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The Hatch-Waxman Litigation practice group at Robins Kaplan LLP is pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the generics business, GENERICally Speaking: A Hatch-Waxman Litigation Bulletin.
Taking on an ANDA patent litigation requires significant corporate resources, time, and money. Staying on top of industry news and outcomes, following trends in the judiciary and the steps others are taking, and keeping informed of recently enacted rules and legislation are critical.
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The Hatch-Waxman Litigation practice group at Robins Kaplan LLP is pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the generics business, GENERICally Speaking: A Hatch-Waxman Litigation Bulletin.
Taking on an ANDA patent litigation requires significant corporate resources, time, and money. Staying on top of industry news and outcomes, following trends in the judiciary and the steps others are taking, and keeping informed of recently-enacted rules and legislation are critical.
This bulletin provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation. We hope you find it helpful.
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In our winter edition of The Robins Kaplan Insurance Insight, we bring you articles on all things tech: from liability exposure in the age of driverless cars and home sharing arrangements, to managing privacy concerns posed by drones and potential coverage for computer hacking. We also discuss the latest initiatives designed to promote gender diversity in the workplace as well as welcome two new women to our team. Finally, we share information on upcoming events for women in the insurance industry.
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In This Issue
The Hatch-Waxman Litigation practice group at Robins Kaplan LLP is pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the generics business, GENERICally Speaking: A Hatch-Waxman Litigation Bulletin.
Taking on an ANDA patent litigation requires significant corporate resources, time, and money. Staying on top of industry news and outcomes, following trends in the judiciary and the steps others are taking, and keeping informed of recently-enacted rules and legislation are critical.
This bulletin provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation. We hope you find it helpful.
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Case Name: Endo Pharm., Inc. v. Actavis LLC, No. 2018-1054, 2019 U.S. App. LEXIS 13348 (Fed. Cir. May 3, 2019) (Circuit Judges Wallach, Clevenger, and Stoll presiding; Opinion by Wallach; Dissent by Stoll) (Appeal from D. Del., Andrews, J.)
Drug Product and Patent(s)-in-Suit: Opana® ER; U.S. Patent No. 8,871,779 (“the ’779 patent)
Nature of Case and Issue(s) Presented: Plaintiffs Endo and Mallinckrodt sued Actavis alleging infringement of the ’779 patent, which Endo licenses from Mallinckrodt. The district court held that Actavis failed to prove that any claims were invalid as obvious or anticipated and entered final judgment of infringement based on a stipulation by the parties. Actavis appealed, contending that the district court erred by misconstruing a claim term and finding claims 1-6 were not obvious in light of prior art. The Federal Circuit, in a majority opinion, affirmed the district court.
The ‘779 patent relates to morphinan alkaloid compounds, such as oxymorphone, which have “great medical importance” and “are used extensively for pain relief.” Id. at *2. Pharmaceutically desirable morphinan compounds often have a ketone group and a single (saturated) bond between two carbon atoms positioned α and β to the ketone group (“morphinan-6-one compounds”). Morphinan-6-one compounds are produced using various processes, many of which involve some form of catalytic hydrogenation of α,β-unsaturated ketone intermediate compounds (“ABUKs”). The relevant ABUKs in this case were 14-hydroxymorphinones, or oxymorphone ABUKs, which are ABUK impurities in oxymorphone that are also considered a precursor to oxymorphone because they can be converted into oxymorphone. Catalytic hydrogenation of oxymorphone ABUKs converts the double (unsaturated) bond to a single (saturated) bond by adding a hydrogen atom. However, this process can result in ABUKs persisting as impurities in the final product and can undesirably reduce ketone, which is a key functional part of oxymorphone.
The ‘779 patent discloses processes for producing oxymorphone that has relatively low concentrations of ABUK impurities. These processes reduce ABUK impurities by treating a reaction mixture including oxymorphone and an ABUK with a sulfur–containing compound. This treatment can reduce ABUK concentrations to levels less than 0.001% by weight or 10 parts per million (“ppm”) with minimal side reactions, ketone reduction, or other undesirable effects.
The 0.001% oxymorphone ABUK concentration level stemmed from FDA communications with Mallinckrodt that outlined the FDA’s processes for addressing the problem of mutagenic oxymorphone impurities. Specifically, the communications disclosed that an ABUK concentration of 0.001% in oxymorphone was required to satisfy FDA approval guidelines.
Why Endo Prevailed: The Federal Circuit first addressed the issue of claim construction. The district court found that a POSA would understand the 14‑hydroxymorphinone, an α, β unsaturated ketone, or “ABUK,” limitations stated in claims 1, 2, and 5 to mean “14-hydroxymorphinone hydrochloride.” Actavis argued that the term did not need to be construed because of its plain meaning and the undisputed chemical difference between 14‑hydroxymorphinone and its hydrochloride salt. The Federal Circuit disagreed. The asserted claims only claimed 14-hydroxymorphinone as part of the salt or hydrochloride form of the claimed compounds, not as a separate non-salt or hydrochloride component, which indicated that 14-hydroxymorphinone as used in the claims meant 14‑hydroxymorphinone hydrochloride. This was confirmed by both parties’ experts.
Next, the Federal Circuit addressed the obviousness issue. Three references constituted prior art. “Weiss” disclosed the use of catalytic hydrogenation to convert oxymorphone ABUK to oxymorphone, specifically, employing palladium charcoal as a catalyst to obtain oxymorphone. “Chapman” disclosed processes that employ catalytic hydrogenation to purify oxycodone ABUK into the salt form of oxycodone. Chapman recites processes that convert oxycodone ABUK to oxycodone diol, a precursor to oxycodone ABUK, which can frustrate purification by reverting to oxycodone ABUK through the compound’s conversion to salt form. Chapman provides a reaction that can remove oxycodone diol from a sample before purification is complete to prevent its reversion to oxycodone ABUK. Finally, “Rapoport” discloses a process to convert oxycodone ABUK to oxycodone by adding bisulfite to separate oxycodone from oxycodone ABUK.
The Federal Circuit agreed with the district court that a POSA would not have a reasonable expectation of success in combining the prior art references. First, a POSA would not have a reasonable expectation of success employing Weiss’s catalytic hydrogenation process for oxymorphone with Chapman’s process for removing diol hydrogenation. While Weiss disclosed a method of purifying oxymorphone ABUK through catalytic hydrogenation, it was missing the following: (i) key reaction conditions, such as the time the reaction is run, the amount and composition of the catalyst, and the pressure of hydrogen gas; (ii) any level of achieved purification of oxymorphone let alone purification to the degree claimed by the ‘779 patent; and (iii) a disclosure that catalytic hydrogenation of oxymorphone ABUK produces oxymorphone diol much more readily than oxycodone ABUK and is thus much less effective on oxymorphone ABUK because oxymorphone diol hinders purification by reverting to oxymorphone ABUK. Similarly, Chapman disclosed a process to hydrogenate oxycodone ABUK that creates oxycodone diol, which can hinder purification by reverting to ABUK after an attempted purification. The Chapman process also likely does not achieve the same purity as the process claimed by the ‘779 patent. The only example provided in Chapman reduced the oxycodone diol content of an oxycodone sample to 400 ppm, well above the 10 ppm limit claimed by the ‘779 patent. The example also had a long reaction time of approximately 20 hours, which is undesirable because the longer a hydrogenation reactions runs, the less diol is removed and the more side reactions that introduce other materials occur. More side reactions result in less of the desired product, ketone, in the final product.
Second, Rapoport’s sulfur addition and separation process did not confer a reasonable expectation of success to remove oxymorphone impurities because: (i) Rapoport does not state that any of its disclosed compounds have the purity levels claimed by the ‘779 patent; and (ii) the processes also resulted in a large loss of the desired compound, ketone.
Third, the teaching of Weiss, Chapman, and Rapoport in view of the FDA communications would not provide a POSA with a reasonable expectation of successfully achieving the oxymorphone purity levels claimed by the ‘779 patent. The FDA mandated a 0.001% or 10 ppm ABUK content in oxymorphone, which incentivized purifying oxymorphone to the level claimed by the ‘779 patent, but did not teach how the mandate could be attained. Accordingly, the FDA communications conveyed nothing that would have led a POSA to believe that the sulfur process described in Rapoport might be more effective on oxymorphone ABUK. Therefore, the FDA communications would not have been enough to overcome the disclosures of Weiss, Chapman, and Rapoport, which indicated that a POSA would not reasonably believe their disclosed methods were fruitful avenues to achieve the FDA-mandated oxymorphone purity level.
Finally, the Federal Circuit held that the district court did not err as a matter of law by imposing a heightened standard for the reasonable expectation test. Actavis argued that the district court’s statement that a POSA would not find a “definitive solution” to the diol problem in Chapman improperly heightened the standard for the reasonable expectation test. However, this was not sufficient to find legal error because the statement was “isolated” and “stripped from its context.”
| Case Name | Date Filed | Judge | Drug | Patent No(s). |
|---|---|---|---|---|
| Pharmacyclics LLC v. Hetero USA Inc., 19-0014 (D. Del.) | Jan. 4, 2019 | Hon. Colm F. Connolly | Imbruvica® (ibrutinib capsules) | 10,106,548 |
| Valeant Pharms. North America LLC v. Strides Pharma Inc., 19-0133 (D.N.J.) | Jan. 4, 2019 | Hon. Peter G. Sheridan | Jublia® (efinaconazole topical solution) | 10,105,444 |
| Celgene Corp. v. Aurobindo Pharma Ltd., 19-0143 (D.N.J.) | Jan. 4, 2019 | Hon. Esther Salas | Pomalyst® (pomalidomide capsules) | 9,993,467 |
| Arbor Pharms., LLC v. Teva Pharms. USA, Inc., 19-0053 (D. Del.) | Jan. 9, 2019 | Hon. Colm F. Connolly | Sklice® (ivermectin lotion) | 8,791,153 8,927,595 |
| Bristol-Myers Squibb Co. v. Unichem Labs., Ltd., 19-0055 (D. Del.) | Jan. 9, 2019 | Hon. Leonard P. Stark | Eliquis® (apixaban tablets) | 6,967,208 |
| Sun Pharm. Indus. Ltd. v. Novartis Pharms. Corp., 19-0276 (D.N.J.) | Jan. 9, 2019 | Hon. Susan D. Wigenton | Jadenu® (deferasirox tablets) | 9,283,209 |
| Moderna Therapeutics, Inc. v. Arbutus Biopharma Corp., IPR2019-00554 (PTAB) | Jan. 9, 2019 | N/A | Onpattro® (patisiran sodium for injection) | 8,058,069 |
| Onyx Therapeutics, Inc. v. Breckenridge Pharm., Inc., 19-0071 (D. Del.) | Jan. 11, 2019 | Hon. Leonard P. Stark | Kyprolis® (carfilzomib for injection) | 7,417,042 7,737,112 8,207,125 |
| Genentech, Inc. v. Laurus Labs Ltd., 19-0078 (D. Del.) | Jan. 14, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone capsules) | 7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 7,696,236 7,767,225 7,988,994 8,753,679 |
| Gilead Sciences, Inc. v. Zydus Pharms. (USA) Inc., 19-0529 (D.N.J.) | Jan. 15, 2019 | Hon. Brian R. Martinotti | Truvada® (emtricitabine / tenofovir disoproxil fumarate tablets) | 6,642,245 6,703,396 8,592,397 8,716,264 9,457,036 9,744,181 |
| Genentech, Inc. v. Aurobindo Pharma Ltd., 19-0103 (D. Del.) | Jan. 17, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone capsules) | 7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 7,696,236 7,767,225 7,988,994 8,753,679 |
| Genentech, Inc. v. Laurus Labs Ltd., 19-0104 (D. Del.) | Jan. 17, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone tablets) | 7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 |
| Genentech, Inc. v. Aurobindo Pharma Ltd., 19-0105 (D. Del.) | Jan. 17, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone tablets) | 7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 9,561,217 |
| Beloteca, Inc. v. Apicore US LLC, 19-0360 (N.D. Ill.) | Jan. 17, 2019 | Hon. John J. Tharp, Jr. | Lymphazurin® (isosulfan blue for injection) | 7,662,992 8,969,616 9,353,050 |
| Genentech, Inc. v. Lupin Ltd., 19-0109 (D. Del.) | Jan. 18, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone capsules) | 7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 7,696,236 7,767,225 7,988,994 8,753,679 |
| Genentech, Inc. v. Lupin Ltd., 19-0110 (D. Del.) | Jan. 18, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone tablets) | 7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 |
| Genentech, Inc. v. Micro Labs Ltd., 19-0111 (D. Del.) | Jan. 18, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone tablets) | 7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 |
| Genentech, Inc. v. Apotex Inc., 19-0120 (D. Del.) | Jan. 22, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone capsules) | 7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 7,696,236 7,767,225 7,988,994 8,753,679 |
| Genentech, Inc. v. Apotex Inc., 19-0123 (D. Del.) | Jan. 22, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone tablets) | 7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 9,561,217 |
| Par Pharm., Inc. v. Pfizer Inc., 19-0615 (S.D.N.Y.) | Jan. 22, 2019 | Hon. William H. Pauley, III | Chantix® (varenicline tartrate tablets) | 6,890,927 7,265,119 |
| Genentech, Inc. v. Shilpa Medicare Ltd., 19-0130 (D. Del.) | Jan. 23, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone tablets) | 8,383,150 8,778,947 |
| Genentech, Inc. v. SciGen Pharms. Inc., 19-0131 (D. Del.) | Jan. 23, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone tablets) | 8,383,150 9,561,217 |
| Genentech, Inc. v. SciGen Pharms. Inc., 19-0132 (D. Del.) | Jan. 23, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone capsules) | 8,383,150 8,420,674 7,767,225 7,988,994 8,753,679 |
| Valeant Pharms. North America LLC v. Cipla Ltd., 19-0988 (D.N.J.) | Jan. 23, 2019 | Hon. Peter G. Sheridan | Jublia® (efinaconazole topical solution) | 10,105,444 |
| Valeant Pharms. North America LLC v. Teva Pharms. USA, Inc., 19-0990 (D.N.J.) | Jan. 23, 2019 | Hon. Peter G. Sheridan | Jublia® (efinaconazole topical solution) | 10,105,444 |
| Genentech, Inc. v. Teva Pharms. USA, Inc., 19-0136 (D. Del.) | Jan. 24, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone tablets) | 7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 |
| Taro Pharm. Indus. Ltd. v. Novitium Pharma, LLC, 19-1028 (D.N.J.) | Jan. 24, 2019 | Hon. Freda L. Wolfson | Ovide® (malathion lotion) | 7,560,445 7,977,324 |
| Japan Tobacco Inc. v. Mylan Pharms. Inc., 19-0012 (N.D.W.V.) | Jan. 24, 2019 | Hon. Irene M. Keeley | Stribild® (elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil fumarate tablets) | 8,633,219 |
| Genentech, Inc. v. Accord Healthcare, Inc., 19-0141 (D. Del.) | Jan. 25, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone capsules) | 7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 7,696,236 7,767,225 7,988,994 8,753,679 |
| Genentech, Inc. v. Accord Healthcare, Inc., 19-0142 (D. Del.) | Jan. 25, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone tablets) | 7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 |
| Pharmacyclics LLC v. Zydus Worldwide DMCC, 19-0143 (D. Del.) | Jan. 25, 2019 | Hon. Colm F. Connolly | Imbruvica® (ibrutinib capsules) | 7,514,444 8,008,309 8,697,711 8,735,403 8,957,079 9,181,257 8,754,091 8,497,277 8,952,015 8,476,284 8,754,090 9,296,753 9,725,455 10,125,140 10,106,548 |
| Genentech, Inc. v. Macleods Pharms. Ltd., 19-0154 (D. Del.) | Jan. 28, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone capsules) |
7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 7,696,236 7,767,225 7,988,994 8,753,679 |
| Genentech, Inc. v. Granules Pharms., Inc., 19-0164 (D. Del.) | Jan. 28, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone tablets) | 8,383,150 8,420,674 8,778,947 |
| Genentech, Inc. v. Alembic Pharms., Ltd., 19-0177 (D. Del.) | Jan. 29, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone tablets) | 7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 |
| Genentech, Inc. v. Hetero Labs Ltd., 19-0178 (D. Del.) | Jan. 29, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone tablets) | 7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 |
| Genentech, Inc. v. Amneal Pharms. LLC, 19-0190 (D. Del.) | Jan. 30, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone tablets) | 7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 |
| Genentech, Inc. v. Amneal Pharms. LLC, 19-0195 (D. Del.) | Jan. 30, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone capsules) | 7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 7,696,236 7,767,225 7,988,994 8,753,679 |
| Galephar Pharm. Research, Inc. v. Upsher-Smith Labs., LLC, 19-2546 (D.N.J.) | Jan. 30, 2019 | Hon. Madeline Cox Arleo | Absorica® (isotretinoin capsules) | 7,435,427 8,367,102 8,952,064 9,078,925 9,089,534 |
| Genentech, Inc. v. Sandoz, Inc., 19-0202 (D. Del.) | Jan. 31, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone tablets) | 7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 9,561,217 |
| Genentech, Inc. v. Sandoz, Inc., 19-0203 (D. Del.) | Jan. 31, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone capsules) | 7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 7,696,236 7,767,225 7,988,994 8,753,679 |
| Genentech, Inc. v. MSN Labs. Private Ltd., 19-0205 (D. Del.) | Jan. 31, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone tablets) | 8,383,150 8,778,947 |
| Biogen Int’l GmbH v. Hetero USA Inc., 19-0211 (D. Del.) | Jan. 31, 2019 | Hon. Leonard P. Stark | Tecfidera® (dimethyl fumarate delayed-release capsules) | 7,619,001 |
| Genentech, Inc. v. Cipla Ltd., 19-0219 (D. Del.) | Feb. 1, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone tablets) | 7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 |
| Keryx Biopharmaceuticals, Inc. v. Chemo Research S.L., 19-0220 (D. Del.) | Feb. 1, 2019 | Hon. Leonard P. Stark | Auryxia® (ferric citrate tablets) | 5,753,706 7,767,851 8,093,423 8,299,298 8,338,642 8,609,896 8,754,257 8,754,258 8,846,976 8,901,349 9,050,316 9,328,133 9,387,191 9,757,416 |
| Leo Pharma A/S v. Taro Pharms. U.S.A., 19-0221 (D. Del.) | Feb. 1, 2019 | Hon. Colm F. Connolly | Finacea® (azelaic acid foam) | 7,700,076 8,435,498 8,722,021 8,900,554 9,211,259 9,265,725 10,117,812 |
| Genentech, Inc. v. Aizant Drug Research Solutions Pvt. Ltd., 19-0223 (D. Del.) | Feb. 1, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone tablets) | 7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 |
| Par Pharm., Inc. v. Merck Sharp & Dohme Corp., 19-4432 (D.N.J.) | Feb. 1, 2019 | Hon. Madeline Cox Arleo | Janumet® XR (sitagliptin phosphate / metformin HCl extended-release tablets) | 7,326,708 |
| Leo Pharma A/S v. Taro Pharms. U.S.A., 19-1051 (S.D.N.Y.) | Feb. 4, 2019 | Hon. Colleen McMahon | Finacea® (azelaic acid foam) | 7,700,076 8,435,498 8,722,021 8,900,554 9,211,259 9,265,725 10,117,812 |
| Genzyme Corp. v. Zenara Pharma Private Ltd., 19-0264 (D. Del.) | Feb. 7, 2019 | Hon. Colm F. Connolly | Cerdelga® (eliglustat capsules) | 6,916,802 7,196,205 7,253,185 7,615,573 |
| Corcept Therapeutics Inc. v. Teva Pharms. USA, Inc., 19-5066 (D.N.J.) | Feb. 8, 2019 | Hon. Susan D. Wigenton | Korlym® (mifepristone tablets) | 10,166,242 10,166,243 10,195,214 |
| Genzyme Corp. v. Zenara Pharma Private Ltd., 19-5160 (D.N.J.) | Feb. 8, 2019 | Hon. Brian R. Martinotti | Cerdelga® (eliglustat capsules) | 6,916,802 7,196,205 7,253,185 7,615,573 |
| Valeant Pharms. North America LLC v. Zydus Pharms. (USA) Inc., 19-5162 (D.N.J.) | Feb. 8, 2019 | Hon. Peter G. Sheridan | Jublia® (efinaconazole topical solution) | 10,105,444 |
| Biogen Int’l GmbH v. Accord Healthcare Inc., 19-0303 (D. Del.) | Feb. 12, 2019 | Hon. Leonard P. Stark | Tecfidera® (dimethyl fumarate delayed-release capsules) | 7,619,001 |
| Meda Pharms. Inc. v. Aurobindo Pharma Ltd., 19-5501 (D.N.J.) | Feb. 12, 2019 | Hon. Brian R. Martinotti | Astepro® (azelastine HCl nasal spray) | 8,071,073 8,518,919 9,919,050 |
| Merck Sharp & Dohme Corp. v. Alvogen Pine Brook LLC, 19-0310 (D. Del.) | Feb. 13, 2019 | Hon. Richard G. Andrews | Janumet® XR (sitagliptin phosphate / metformin HCl extended-release tablets) | 7,326,708 |
| Merck Sharp & Dohme Corp. v. Anchen Pharms., Inc., 19-0311 (D. Del.) | Feb. 13, 2019 | Hon. Richard G. Andrews | Janumet® XR (sitagliptin phosphate / metformin HCl extended-release tablets) | 7,326,708 |
| Merck Sharp & Dohme Corp. v. Sandoz Inc., 19-0312 (D. Del.) | Feb. 13, 2019 | Hon. Richard G. Andrews | Janumet® XR (sitagliptin phosphate / metformin HCl extended-release tablets) Januvia® (sitagliptin phosphate) | 7,326,708 |
| Merck Sharp & Dohme Corp. v. Apotex Inc., 19-0313 (D. Del.) | Feb. 13, 2019 | Hon. Richard G. Andrews | Janumet® XR (sitagliptin phosphate / metformin HCl extended-release tablets) Januvia® (sitagliptin phosphate) Janumet® (sitagliptin phosphate / metformin HCl) | 7,326,708 |
| Merck Sharp & Dohme Corp. v. Zydus Pharms. (USA) Inc., 19-0314 (D. Del.) | Feb. 13, 2019 | Hon. Richard G. Andrews | Janumet® XR (sitagliptin phosphate / metformin HCl extended-release tablets) Januvia® (sitagliptin phosphate) Janumet® (sitagliptin phosphate / metformin HCl) | 7,326,708 |
| Merck Sharp & Dohme Corp. v. Mylan Pharms. Inc., 19-0315 (D. Del.) | Feb. 13, 2019 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate) | 7,326,708 8,414,921 |
| Merck Sharp & Dohme Corp. v. Macleods Pharms. Ltd., 19-0316 (D. Del.) | Feb. 13, 2019 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate) Janumet® (sitagliptin phosphate / metformin HCl) | 7,326,708 |
| Merck Sharp & Dohme Corp. v. Watson Labs., Inc., 19-0317 (D. Del.) | Feb. 13, 2019 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate) | 7,326,708 8,414,921 |
| Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc., 19-0318 (D. Del.) | Feb. 13, 2019 | Hon. Richard G. Andrews | Janumet® XR (sitagliptin phosphate / metformin HCl extended-release tablets) Januvia® (sitagliptin phosphate) Janumet® (sitagliptin phosphate / metformin HCl) Juvisync® (simvastatin/ sitagliptin phosphate) | 7,326,708 |
| Merck Sharp & Dohme Corp. v. Sun Pharma Global FZE, 19-0319 (D. Del.) | Feb. 13, 2019 | Hon. Richard G. Andrews | Janumet® XR (sitagliptin phosphate / metformin HCl extended-release tablets) Januvia® (sitagliptin phosphate) Janumet® (sitagliptin phosphate / metformin HCl) | 7,326,708 8,414,921 |
| Merck Sharp & Dohme Corp. v. Torrent Pharms. Ltd., 19-0320 (D. Del.) | Feb. 13, 2019 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate) | 7,326,708 |
| Merck Sharp & Dohme Corp. v. Wockhardt Bio AG, 19-0321 (D. Del.) | Feb. 13, 2019 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate) Janumet® (sitagliptin phosphate / metformin HCl) | 7,326,708 |
| Genentech, Inc. v. Torrent Pharms. Ltd., 19-0324 (D. Del.) | Feb. 14, 2019 | Hon. Richard G. Andrews | Esbriet® (pirfenidone tablets) | 8,383,150 8,778,947 |
| Celgene Corp. v. Hetero Labs Ltd., 19-5797 (D.N.J.) | Feb. 14, 2019 | Hon. Esther Salas | Pomalyst® (pomalidomide capsules) | 10,093,647 10,093,648 10,093,649 |
| Celgene Corp. v. Aurobindo Pharma Ltd., 19-5799 (D.N.J.) | Feb. 14, 2019 | Hon. Esther Salas | Pomalyst® (pomalidomide capsules) | 10,093,647 10,093,648 10,093,649 |
| Celgene Corp. v. Mylan Pharms. Inc., 19-5802 (D.N.J.) | Feb. 14, 2019 | Hon. Esther Salas | Pomalyst® (pomalidomide capsules) | 10,093,647 10,093,648 10,093,649 |
| Celgene Corp. v. Breckenridge Pharm., Inc., 19-5804 (D.N.J.) | Feb. 14, 2019 | Hon. Esther Salas | Pomalyst® (pomalidomide capsules) | 10,093,647 10,093,648 10,093,649 |
| Celgene Corp. v. Apotex Inc., 19-5806 (D.N.J.) | Feb. 14, 2019 | Hon. Esther Salas | Pomalyst® (pomalidomide capsules) | 10,093,647 10,093,648 10,093,649 |
| Valeant Pharms. North America LLC v. Apotex Inc., 19-5939 (D.N.J.) | Feb. 15, 2019 | Hon. Peter G. Sheridan | Jublia® (efinaconazole topical solution) | 10,105,444 |
| Biogen Int’l GmbH v. Zydus Pharms. (USA) Inc., 19-5987 (D.N.J.) | Feb. 15, 2019 | Hon. Brian R. Martinotti | Tecfidera® (dimethyl fumarate delayed-release capsules) | 7,619,001 |
| Merck Sharp & Dohme Corp. v. Lupin Ltd., 19-0347 (D. Del.) | Feb. 19, 2019 | Hon. Richard G. Andrews | Janumet® (sitagliptin phosphate / metformin HCl) | 7,326,708 |
| Galderma Labs. L.P. v. Teva Pharms. USA, Inc., 19-0351 (D. Del.) | Feb. 19, 2019 | Hon. Richard G. Andrews | Soolantra® (ivermectin cream) | 10,206,939 |
| Nalox-1 Pharms., LLC v. Opiant Pharms., Inc., IPR2019-000685 (PTAB) | Feb. 19, 2019 | N/A | Narcan® (naloxone HCl nasal spray) | 9,211,253 |
| Nalox-1 Pharms., LLC v. Opiant Pharms., Inc., IPR2019-000686 (PTAB) | Feb. 19, 2019 | N/A | Narcan® (naloxone HCl nasal spray) | 9,211,253 |
| Nalox-1 Pharms., LLC v. Opiant Pharms., Inc., IPR2019-000687 (PTAB) | Feb. 19, 2019 | N/A | Narcan® (naloxone HCl nasal spray) | 9,211,253 |
| Nalox-1 Pharms., LLC v. Opiant Pharms., Inc., IPR2019-000688 (PTAB) | Feb. 19, 2019 | N/A | Narcan® (naloxone HCl nasal spray) | 9,468,747 |
| Nalox-1 Pharms., LLC v. Opiant Pharms., Inc., IPR2019-000689 (PTAB) | Feb. 19, 2019 | N/A | Narcan® (naloxone HCl nasal spray) | 9,468,747 |
| Nalox-1 Pharms., LLC v. Opiant Pharms., Inc., IPR2019-000690 (PTAB) | Feb. 19, 2019 | N/A | Narcan® (naloxone HCl nasal spray) | 9,468,747 |
| Nalox-1 Pharms., LLC v. Opiant Pharms., Inc., IPR2019-000691 (PTAB) | Feb. 19, 2019 | N/A | Narcan® (naloxone HCl nasal spray) | 9,561,177 |
| Nalox-1 Pharms., LLC v. Opiant Pharms., Inc., IPR2019-000692 (PTAB) | Feb. 19, 2019 | N/A | Narcan® (naloxone HCl nasal spray) | 9,561,177 |
| Nalox-1 Pharms., LLC v. Opiant Pharms., Inc., IPR2019-000693 (PTAB) | Feb. 19, 2019 | N/A | Narcan® (naloxone HCl nasal spray) | 9,561,177 |
| Nalox-1 Pharms., LLC v. Opiant Pharms., Inc., IPR2019-000694 (PTAB) | Feb. 19, 2019 | N/A | Narcan® (naloxone HCl nasal spray) | 9,629,965 |
| Nalox-1 Pharms., LLC v. Opiant Pharms., Inc., IPR2019-000695 (PTAB) | Feb. 19, 2019 | N/A | Narcan® (naloxone HCl nasal spray) | 9,629,965 |
| Nalox-1 Pharms., LLC v. Opiant Pharms., Inc., IPR2019-000696 (PTAB) | Feb. 19, 2019 | N/A | Narcan® (naloxone HCl nasal spray) | 9,629,965 |
| Nalox-1 Pharms., LLC v. Opiant Pharms., Inc., IPR2019-000697 (PTAB) | Feb. 19, 2019 | N/A | Narcan® (naloxone HCl nasal spray) | 9,775,838 |
| Nalox-1 Pharms., LLC v. Opiant Pharms., Inc., IPR2019-000698 (PTAB) | Feb. 19, 2019 | N/A | Narcan® (naloxone HCl nasal spray) | 9,775,838 |
| Nalox-1 Pharms., LLC v. Opiant Pharms., Inc., IPR2019-000699 (PTAB) | Feb. 19, 2019 | N/A | Narcan® (naloxone HCl nasal spray) | 9,775,838 |
| Celgene Corp. v. Apotex Inc., 19-6999 (D.N.J.) | Feb. 26, 2019 | Hon. Susan D. Wigenton | Revlimid® (lenalidomide capsules) | 7,189,740 8,404,717 9,056,120 |
| Mitsubishi Tanabe Pharma Corp. v. Lupin Ltd., 19-7165 (D.N.J.) | Feb. 27, 2019 | Hon. Peter G. Sheridan | Invokamet XR® (canagliflozin / metformin HCl extended-release tablets) | 7,943,582 8,513,202 |
| Valeant Pharms. North America LLC v. Macleods Pharms. Ltd., 19-7296 (D.N.J.) | Feb. 28, 2019 | Hon. Peter G. Sheridan | Jublia® (efinaconazole topical solution) | 10,105,444 |
| Pharmacyclics LLC v. Alvogen Pine Brook LLC, 19-0434 (D. Del.) | Mar. 1, 2019 | Hon. Colm F. Connolly | Imbruvica® (ibrutinib capsules) | 7,514,444 8,008,309 8,476,284 8,497,277 8,697,711 8,735,403 8,754,090 8,754,091 8,952,015 8,957,079 9,181,257 9,296,753 9,655,857 9,725,455 10,010,507 10,106,548 10,125,140 |
| Endo Pharms. Inc. v. Perrigo UK Finco Ltd., 19-0437 (D. Del.) | Mar. 1, 2019 | Hon. Maryellen Noreika | Nascobal® (cyanocobalamin nasal spray) | 7,229,636 7,404,489 7,879,349 8,003,353 8,940,714 9,415,007 |
| Cipla Ltd. v. AstraZeneca AB, 19-0438 (D. Del.) | Mar. 1, 2019 | Hon. Maryellen Noreika | Nexium® (esomeprazole magnesium delayed-release oral suspension) | 6,428,810 |
| Galderma Labs., L.P. v. Amneal Pharms. LLC, 19-0440 (D. Del.) | Mar. 1, 2019 | Hon. Leonard P. Stark | Oracea® (doxycycline capsules) | 10,058,564 |
| Biodelivery Sciences Int’l, Inc. v. Chemo Research, S.L., 19-0444 (D. Del.) | Mar. 1, 2019 | Hon. Colm F. Connolly | Belbuca® (buprenorphine buccal film) | 8,147,866 9,655,843 9,901,539 |
| Sun Pharm. Indus. Ltd. v. Vistapharm, Inc., 19-7536 (D.N.J.) | Mar. 1, 2019 | Hon. Stanley R. Chesler | Riomet® (metformin HCl oral solution) | 6,890,957 |
| Apicore US LLC v. Beloteca, Inc., 19-0077 (E.D. Tex.) | Mar. 4, 2019 | Hon. Rodney Gilstrap | Isosulfan blue for injection | 8,969,616 9,353,050 |
| Sawai USA, Inc. v. Biogen MA, Inc., IPR2019-00789 (PTAB) | Mar. 4, 2019 | N/A | Tecfidera® (dimethyl fumarate delayed-release capsules) | 8,399,514 |
| Millennium Pharms., Inc. v. Aurobindo Pharma USA Inc., 19-0471 (D. Del.) | Mar. 6, 2019 | Hon. Colm F. Connolly | Velcade® (bortezomib for injection) | 6,713,446 6,958,319 |
| UCB, Inc. v. Actavis Labs. UT, Inc., 19-0474 (D. Del.) | Mar. 6, 2019 | Hon. Leonard P. Stark | Neupro® (rotigotine transdermal system) | 10,130,589 |
| Valeant Pharms. North America LLC v. Slayback Pharma, LLC, 19-8218 (D.N.J.) | Mar. 8, 2019 | Hon. Peter G. Sheridan | Jublia® (efinaconazole topical solution) | 10,105,444 |
| Valeant Pharms. North America LLC v. Mylan Pharms. Inc., 19-8233 (D.N.J.) | Mar. 8, 2019 | Hon. Peter G. Sheridan | Jublia® (efinaconazole topical solution) | 10,105,444 |
| Valeant Pharms. North America LLC v. Mylan Pharms. Inc., 19-0037 (N.D.W.V.) | Mar. 11, 2019 | Hon. Thomas S. Kleeh | Jublia® (efinaconazole topical solution) | 10,105,444 |
| Pfizer Inc. v. Ajanta Pharma Ltd., 19-0517 (D. Del.) | Mar. 15, 2019 | Hon. Leonard P. Stark | Xeljanz® (tofacitinib tablets) | 6,965,027 RE41,783 |
| Biodelivery Sciences Int’l, Inc. v. Chemo Research, S.L., 19-8660 (D.N.J.) | Mar. 15, 2019 | Hon. Kevin McNulty | Belbuca® (buprenorphine buccal film) | 8,147,866 9,655,843 9,901,539 |
| Keryx Biopharmaceuticals, Inc. v. Mylan Pharms. Inc., 19-0040 (N.D.W.V.) | Mar. 15, 2019 | Hon. Thomas S. Kleeh | Auryxia® (ferric citrate tablets) | 5,753,706 7,767,851 8,093,423 8,299,298 8,338,642 8,609,896 8,754,257 8,754,258 8,846,976 8,901,349 9,050,316 9,328,133 9,387,191 9,757,416 |
| Celgene Corp. v. Teva Pharms. USA, Inc., 19-8758 (D.N.J.) | Mar. 19, 2019 | Hon. Esther Salas | Pomalyst® (pomalidomide capsules) | 10,093,647 10,093,648 10,093,649 |
| Mayne Pharma Int’l Pty Ltd. v. Prinston Pharm. Inc., 19-0549 (D. Del.) | Mar. 21, 2019 | Hon. Richard G. Andrews | Doryx® MPC (doxycycline hyclate delayed-release tablets) | 9,295,652 9,446,057 9,511,031 |
| Sandoz Inc. v. Pharmacyclics LLC, IPR2019-00865 (PTAB) | Mar. 21, 2019 | N/A | Imbruvica® (ibrutinib tablets) Imbruvica® (ibrutinib capsules) | 9,795,604 |
| Mallinckrodt Hospital Products IP Ltd. v. Altan Pharma Ltd., 19-0552 (D. Del.) | Mar. 22, 2019 | Hon. Leonard P. Stark | Ofirmev® (acetaminophen for injection) | 9,399,012 9,610,265 9,987,238 6,992,218 |
| Vanda Pharms. Inc. v. Teva Pharms. USA, Inc., 19-0560 (D. Del.) | Mar. 22, 2019 | Hon. Colm F. Connolly | Hetlioz® (tasimelteon capsules) | 10,149,829 |
| Indivior Inc. v. Aveva Drug Delivery Systems, Inc., 19-60757 (S.D. Fla.) | Mar. 22, 2019 | Hon. Beth Bloom | Suboxone® (buprenorphine HCl / naloxone HCl sublingual film) | 8,017,150 8,603,514 9,687,454 9,931,305 |
| Boehringer Ingelheim Pharma GmbH & Co. KG v. Aurobindo Pharma Ltd., 19-8840 (D.N.J.) | Mar. 22, 2019 | Hon. Brian R. Martinotti | Pradaxa® (dabigatran etexilate mesylate capsules) | 6,087,380 |
| Eli Lilly and Co. v. Dr. Reddy’s Labs., Ltd., 19-1246 (S.D. Ind.) | Mar. 27, 2019 | Hon. Jane Magnus-Stinson | Alimta® (pemetrexed for injection) | 7,772,209 |
| Eagle Pharms., Inc. v. Accord Healthcare, Inc., 19-0344 (M.D.N.C.) | Mar. 27, 2019 | Hon. William L. Osteen, Jr. | Argatroban Injections | 7,589,106 7,687,516 |
| Eagle Pharms., Inc. v. Accord Healthcare, Inc., 19-9031 (D.N.J.) | Mar. 27, 2019 | Hon. Claire C. Cecchi | Argatroban Injections | 7,589,106 7,687,516 |
| Reference Listed Drug | NDA Holder | Generic Drug Name | ANDA Applicant(s) | Indication | Launch Date |
|---|---|---|---|---|---|
| Lidex Ointment | County Line Pharmaceuticals | Fluocinonide Ointment | Lupin | indicated for the relief of the inflammatory and pruritic manifestations of Corticosteroid-Responsive Dermatoses | 3/28/2019 |
| Ritalin | Novartis | Methylphenidate HCl ER Tablets | ANI | indicated for the treatment of ADHD in children 6 years of age and older, adolescents, and adults up to the age of 65 | 3/27/2019 |
| E.E.S. | Abbott Labs | Erythromycin Ethylsuccinate for Oral Suspension | ANI | indicated in the treatment of infections caused by susceptible strains of selected diseases | 3/27/2019 |
| Cialis | Eli Lilly and Company | Tadalafil Tablets | Apotex | used to treat Erectile Dysfunction (Impotence) and symptoms of Benign Prostatic Hypertrophy (Enlarged Prostate) | 3/27/2019 |
| Cialis | Eli Lilly and Company | Tadalafil Tablets | Dr. Reddy's | used to treat Erectile Dysfunction (Impotence) and symptoms of Benign Prostatic Hypertrophy (Enlarged Prostate) | 3/27/2019 |
| Prozac | Eli Lilly and Company | Fluoxetine Tablets | Upsher-Smith | used to treat depression, panic attacks, obsessive compulsive disorder, a certain eating disorder (Bulimia), and a severe form of premenstrual syndrome (Premenstrual Dysphoric Disorder) | 3/27/2019 |
| Cialis | Eli Lilly and Company | Tadalafil Tablets | Zydus | used to treat Erectile Dysfunction (Impotence) and symptoms of Benign Prostatic Hypertrophy (Enlarged Prostate) | 3/27/2019 |
| Remodulin | United Therapeutics Corporation | Treprostinil Injection | Sandoz | indicated for Pulmonary Arterial Hypertension (PAH) | 3/25/2019 |
| Levophed | Hospira | Norepinephrine Bitartrate Injection | Hikma | indicated for blood pressure control in certain acute hypotensive states | 3/22/2019 |
| Synthroid | AbbVie | Levothyroxine Sodium Tablets | Lupin | indicated for Hypothyroidisn and Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) | 3/22/2019 |
| Exjade | Novartis | Deferasirox Tablets for Oral Suspension | Teva | indicated for the treatment of chronic iron overload due to blood transfusions inpatients two years of age and older | 3/22/2019 |
| Exelon Patch | Novartis | Rivastigmine Transdermal System | Amneal | used to treat mild to moderate dementia caused by Alzheimer's or Parkinson's disease | 3/12/2019 |
| Rythmol SR | GlaxoSmithKline | Propafenone HCl ER Capsules | Vitruvias and Sinotherapeutics | is used to help prevent certain types of serious (possibly fatal) irregular heartbeat (such as Paroxysmal Supraventricular is indicated for the treatment of sustained Ventricular Tachycardia that is deemed to be life-threatening | 3/8/2019 |
| Amrix | Teva | Cyclobenzaprine HCl ER Capsules | Teva | for use as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful masculoskeleal conditions | 3/6/2019 |
| Humalog | Eli Lilly and Company | Insulin Lispro Injection | Eli Lilly and Company (ImClone) | used to control high blood sugar in adults and children with diabetes mellitus | 3/4/2019 |
| Tekturna | Noden Pharma DAC | Aliskiren Hemifumarate Tablets | Prasco | indicated for the treatment of Hypertension in adults and children 6 years of age and older | 3/4/2019 |
| Amrix | Teva | Cyclobenzaprine HCl ER Capsules | Apotex | is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions | 3/1/2019 |
| Lovaza | GlaxoSmithKline | Omega-3 Acid Ethyl Esters Capsules | Camber Pharmaceuticals | used to lower levels of Triglycerides and may raise "good" Cholesterol | 3/1/2019 |
| Flector Patch | IBSA Institute Biochimique SA | Diclofenac Epolamine Topical Patch | Teva | used as a pain reliver indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions | 3/1/2019 |
| Amrix | Teva | Cyclobenzaprine HCl ER Capsules | Twi | indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions | 3/1/2019 |
| Rocephin | Hoffmann La Roche | Ceftriaxone for Injection | Apotex | used to treat conditions such as lower respiratory tract infections, skin and skin structure infections, urinary tract infections, pelvic inflammatory disease, bacterial septicemia, bone and joint infections, and Meningitis | 2/28/2019 |
| Ranexa | Gilead Sciences | Ranolazine ER Tablets | Lupin | indicated for the treatment of chronic angina | 2/28/2019 |
| Ocuflox | Allergan | Ofloxacin Ophthalmic Solution | Apotex | used to treat bacterial infections of the eye, including Conjunctivitis (pink eye) and ulcers of the cornea | 2/27/2019 |
| Solodyn | Medicis Pharmaceutical | Minocycline HCl ER Tablets | Lupin | indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older | 2/26/2019 |
| Suboxone | Indivior | Buprenorphine HCl / Naloxone HCl | Mylan | for treatment of Opioid dependence | 2/22/2019 |
| Solodyn | Medicis Pharmaceutical | Minocycline HCl ER Tablets | Teva | indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older | 2/21/2019 |
| Acanya Gel | Dow Pharmaceutical Sciences | Clindamycin Phosphate / Benzoyl Peroxide Gel | Teva | indicated for the topical treatment of acne vulgaris in patients 12 years or older | 2/21/2019 |
| Suboxone | Indivior | Buprenorphine HCl / Naloxone HCl | Alvogen | for treatment of Opioid dependence | 2/20/2019 |
| Suboxone | Indivior | Buprenorphine HCl / Naloxone HCl | Dr. Reddy's | for treatment of Opioid dependence | 2/20/2019 |
| Zarontin | Pfizer | Ethosuximide Softgel Capsules | Strides Shasun | is an anti‐epileptic medication to control brief, sudden loss of consciousness and uncontrolled jerking movements in children and adults | 2/20/2019 |
| Suboxone | Indivior | Buprenorphine HCl / Naloxone HCl | Sandoz | for treatment of Opioid dependence | 2/19/2019 |
| Onfi | Lundbeck | Clobazam Oral Suspension | Lupin | indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older | 2/15/2019 |
| Zytiga | Janssen | Abiraterone Acetate Tablets | Hikma | indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) | 2/14/2019 |
| Detrol LA | Pharmacia & Upjohn | Tolterodine Tartrate ER Capsules | Camber Pharmaceuticals | used to treat overactive bladder | 2/13/2019 |
| Achromycin | Heritage Pharms | Tetracycline Capsules | Breckenridge | used to treat many different bacterial infections, such as Urinary Tract Infections (UTI), Acne, Gonorrhea, Chlamydia, and others | 2/12/2019 |
| Adcirca | Eli Lilly and Company | Tadalafil Tablets | Dr. Reddy's | indicated for the treatment of Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise ability | 2/12/2019 |
| Adcirca | Eli Lilly and Company | Tadalafil Tablets | Lupin | indicated for the treatment of Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise ability | 2/12/2019 |
| Advair Diskus | Glaxo | Fluticasone Propionate / Salmeterol Inhalation Powder | Mylan | is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma or ongoing lung disease (Chronic Obstructive Pulmonary Disease-COPD, which includes Chronic Bronchitis and Emphysema) | 2/12/2019 |
| Advair Diskus | Glaxo | Fluticasone Propionate / Salmeterol Inhalation Powder | Prasco | is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma or ongoing lung disease (Chronic Obstructive Pulmonary Disease-COPD, which includes Chronic Bronchitis and Emphysema) | 2/8/2019 |
| Adcirca | Eli Lilly and Company | Tadalafil Tablets | Cipla | indicated for the treatment of Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise ability | 2/7/2019 |
| Adcirca | Eli Lilly and Company | Tadalafil Tablets | Camber Pharmaceuticals | indicated for the treatment of Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise ability | 2/6/2019 |
| Sabril | Lundbeck | Vigabatrin Tablets | Teva | indicated as adjunctive therapy for adults and children (10 years of age or older) with refractory Complex Partial Seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss | 2/6/2019 |
| Norco | Warner Chilcott | Hydrocodone APAP Tablets | Camber Pharmaceuticals | used to relieve moderate to severe pain | 2/5/2019 |
| Anafranil | SpecGx | Clomipramine HCl Capsules | Lupin | treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD) | 2/5/2019 |
| Adcirca | Eli Lilly and Company | Tadalafil Tablets | Teva | indicated for the treatment of Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise ability | 2/5/2019 |
| Diprivan | Fresenius Kabi | Propofol Injectable Emulsion | Dr. Reddy's | used as initiation and maintenance of Monitored Anesthesia Care (MAC) sedation; combined sedation and regional anesthesia; induction of General Anesthesia Patients greater than or equal to 3 years of age; maintenance of General Anesthesia Patients greater than or equal to 2 months of age; Intensive Care Unit (ICU) sedation of intubated, mechanically ventilated patients | 1/24/2019 |
| Suprane | Baxter Healthcare | Desflurane, Liquid for Inhalation | Sandoz | is an inhalation agent indicated: for induction and/or maintenance of anesthesia in adults (1.1); for maintenance of anesthesia in pediatric patients following induction with agents other than Suprane and intubation | 1/24/2019 |
| Comtan | Novartis | Entacapone Tablets | Lannett | used in the treatment of Parkinson's Disease as an adjunct to Levodopa/Carbidopa Therapy | 1/22/2019 |
| Lovenox | Sanofi Aventis | Enoxaparin Sodium Injection | Apotex | is an anticoagulant (blood thinner) used to prevent blood clots that are sometimes called Deep Vein Thrombosis (DVT), which can lead to blood clots in the lungs | 1/16/2019 |
| Symjepi | Adamis Pharmaceuticals | Epinephrine for Injection | Sandoz | for the emergency treatment of allergic reactions (Type 1), including Anaphylaxis | 1/16/2019 |
| Trandate | County Line Pharmaceuticals | Labetalol HCL Tablets | TWi Pharmaceuticals | indicated for the treatment of Hypertension | 1/16/2019 |
| Albenza | Impax Labs | Albendazole Tablets | Camber Pharmaceuticals | used to treat infections of tapeworms or other parasites | 1/14/2019 |
| Zytiga | Janssen | Abiraterone Acetate | Amneal | is used along with prednisone to treat men with prostate cancer that has spread to other areas of the body | 1/9/2019 |
| Levitra | Baxter Healthcare | Vardenafil HCl Tablets | Teva | indicated for the treatment of Erectile Dysfunction | 1/8/2019 |
| Amgen | Sensipar | Cinacalcet HCl Tablets | Teva | indicated for secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis; also used for the treatment of Hypercalcemia in adult patients with Parathyroid Carcinoma and severe Hypercalcemia in adult patients with primary HPT who are unable to undergo Parathyroidectomy | 12/27/2018 |
| Case Name | Drug | Patent No(s). | Publicly Available Terms |
|---|---|---|---|
| Allergan, Inc. v. Saptalis Pharms., LLC, 18-1231 (D. Del.) | Restasis® (cyclosporine ophthalmic emulsion) | 8,633,162 8,642,556 | N/A |
| Allergan, Inc. v. Amneal Pharms. LLC, 18-1457 (D. Del.) | Restasis® (cyclosporine ophthalmic emulsion) | 8,633,162 8,642,556 | N/A |
| AstraZeneca LP v. Prinston Pharm. Inc., 17-1639 (D. Del.) | Brilinta® (ticagrelor tablets) | 6,251,910 RE 46,276 7,250,419 7,265,124 | Prinston is enjoined from infringing the ’276, ’419, and ’124 patents. All claims, counterclaims, affirmative defenses and demands in this action are hereby dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party. |
| Amgen Inc. v. Watson Labs., Inc., 18-2414 (Fed. Cir.) | Sensipar® (cinacalcet hydrochloride tablets) | 9,375,405 | After launching at-risk, Watson will withdraw its product from the market. Watson will pay Amgen an undisclosed amount. Waston will wait until 2021 to re-launch its generic product. |
| Senju Pharm. Co., Ltd. v. Amneal Pharms. LLC, 18-16991 (D.N.J.) | Prolensa® (bromfenac ophthalmic solution) | 8,129,431 8,669,290 8,754,131 8,871,813 8,927,606 9,144,609 9,517,220 9,561,277 10,085,958 | In the event that the asserted patents against Amneal are not held invalid or unenforceable, Amneal’s admits that its ANDA product infringes those patents. Amneal is enjoined from selling its ANDA product except as permitted by the settlement agreement. Each party to bear its own costs. |
| Chiesi U.S.A., Inc. v. Teva Pharms. USA, Inc., 17-1772 (D. Del.) | Bethkis® (tobramycin injection solution) | 6,987,094 7,696,178 7,939,502 | Teva is enjoined from selling its ANDA product until the expiration of the patents-in-suit. Each party waives its appeal rights. Each party to bear its own costs. All claims are dismissed without prejudice. |
| Delcor Asset Corp. v. Glenmark Pharms. Ltd., 18-0460 (D. Del.) | Olux-E® (clobetasol propionate aerosol foam) | 6,730,288 | Glenmark submitted a patent amendment to revise its certification from Paragraph IV to Paragraph III. All claims and counterclaims are dismissed without prejudice. Parties to bear their own costs and fees. |
| Gilead Sciences, Inc. v. Strides Pharma, Inc., 18-11134 (D.N.J.) | Truvada® (emtricitabine / tenofovir disoproxil fumarate tablets) | 6,642,245 6,703,396 8,592,397 8,716,264 9,457,036 9,744,181 | All claims and counterclaims dismissed with prejudice. Parties to bear their own costs and fees. |
| Sumitomo Dainippon Pharma Co., Ltd. v. Macleods Pharms. Ltd., 18-13833 (D.N.J.) | Latuda® (lurasidone HCl tablets) | 9,815,827 9,907,794 | Macleods admits that the ’827 patent is enforceable and valid. Macleods is enjoined from infringing the ’827 patent. All claims and demands for relief prayed for by Plaintiffs against Macleods and Macleods against Plaintiffs in this action are deemed to be satisfied. |
| Mayne Pharma Int’l Pty Ltd. v. Lupin Ltd., 17-1637 (D. Del.) | Doryx® MPC (doxycycline hyclate delayed-release tablets) | 9,295,652 9,446,057 9,511,031 | Each asserted claim would be infringed by any unlicensed manufacture, sale, offer for sale, use, or importation in the US of the Lupin ANDA Product. Each asserted claim of each of the Licensed Patents is valid and enforceable. Lupin is is enjoined from making, having made, using, selling, offering to sell or distributing the Lupin ANDA Product in, or importing into, the US. Lupin shall be entitled to contest the infringement, validity, and/or enforceability of the Licensed Patents in any future litigation of the Licensed Patents, pertaining to any product that is not the Lupin ANDA Product. Each Party acknowledges and agrees that the 30-month stay with respect to the Lupin ANDA is terminated. All claims, counterclaims, and affirmative defenses are dismissed with prejudice, without costs and fees. |
| AstraZeneca AB v. Apotex Corp., 16-0583 (D. Del.) | Onglyza® (saxagliptin hydrochloride tablets) | RE44,186 | The ’186 patent is enforceable and valid. Apotex ANDA product infringes the ’186 patent. Apotex is enjoined from making, having made, using, selling, offering to sell, importing or distributing its ANDA product until the expiration of the ’186 patent. Pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of the approval of Apotex’s ANDA shall be no earlier than the expiration date of the the ’186 patent. All remaining claims and counterclaims are dismissed with prejudice. The parties waive any right to appeal. |
| Forest Labs., LLC v. Prinston Pharm. Inc., 17-7191 (D.N.J.) | Byvalson® (nebivolol / valsartan tablets) | 7,803,838 7,838,552 | The patents-in-suit are enforceable and valid. Prinston’s filing of its ANDA infringes the patents-in-suit. Prinston is enjoined from making, having made, using, selling, offering to sell, importing or distributing its ANDA product until the expiration of the patents-in-suit. All remaining claims and counterclaims are dismissed with prejudice. The parties waive any right to appeal. |
| Cephalon Inc. v. Innopharma Inc., Nos. 17-2377, 17-2378 (Fed. Cir.) | Treanda® (bendamustine hydrochloride injection) | 8,436,190 8,609,863 8,791,270 8,895,756 | N/A |
| Shire Development LLC v. SpecGx LLC, 18-0800 (D. Del.) | Mydayis® (dextroamphetamine saccharate / amphetamine aspartate monohydrate / dextroamphetamine sulfate / amphetamine sulfate extended-release capsules) | 6,913,768 8,846,100 9,173,857 | SpecGx acknowledges that the ’768 patent is valid and enforceable. SpecGx acknowledges that its ANDA product infringes the ’768 patent. Shire acknowledges that the SpecGx ANDA product does not infringe the ’100 and ’857 patents. Shire and SpecGx agree to dismiss without prejudice all other claims, counterclaims and affirmative defenses. Both parties waive their right to appeal and to seek costs and fees. |
| Pfizer Inc. v. Prinston Pharm. Inc., 18-0380 (D. Del.) | Xeljanz® (tofacitinib tablets) | RE41,783 | All claims and counterclaims between Plaintiffs and Prinston are dismissed without prejudice. Any protective orders entered by the Court shall remain in full force and effect notwithstanding the dismissal of this action. The parties waive any right of appeal. Each party shall bear its own costs and fees. |
| Almirall, LLC v. Taro Pharms. Indus. Ltd., 17-0663 (D. Del.) | Aczone® (dapsone gel) | 9,517,219 | N/A |
| Indivior Inc. v. Alvogen Pine Brook LLC, 18-5285 (D.N.J.) | Suboxone® (buprenorphine HCl / naloxone HCl sublingual film) | 9,931,305 | N/A |
| Pharmacyclics LLC v. Fresenius Kabi USA, LLC, 18-0192 (D. Del.) | Imbruvica® (ibrutinib tablets) | 8,008,309 7,514,444 8,697,711 8,735,403 8,957,079 9,181,257 8,754,091 8,497,277 8,952,015 8,476,284 8,754,090 9,296,753 9,725,455 9,540,382 9,713,617 | No party admits liability. Each party shall bear its own costs, attorney fees, and expenses incurred in connection with the claims dismissed by this Order. Plaintiffs’ claims against Teva and Hetero are dismissed without prejudice. Tevaand Hetero’s claims against Plaintiffs are dismissed without prejudice. |
| Valeant Pharms. North America LLC v. Perrigo Pharma Int’l DAC, 18-17518 (D.N.J.) | Jublia® (efinaconazole topical solution) | 10,105,444 | Perrigo’s ANDA product infringes the ‘444 patent. Perrigo is enjoined from (i) making, using, offering to sell, selling, or importing until expiration of the ‘444 patent the Perrigo ANDA product in the United States, and (ii) participating in the profits from making, using, offering to sell, selling, or importing the Perrigo Product in the United States, and (iii) indemnifying others with respect to any making, using, offering to sell, selling, or importing the Perrigo Product in the United States. Each party will bear its own attorneys’ fees and costs. Perrigo is entitled to maintain its Paragraph IV certification to the ‘444 Patent pursuant to 21 C.F.R. § 314.94(a)(12)(v). The 30-month stay with respect to the approval of the Perrigo ANDA is terminated. |
| Osi Pharms., LLC v. Shilpa Medicare Ltd., 18-1096 (D. Del.) | Tarceva® (erlotinib HCl tablets) | 6,900,221 | The complaint is dismissed, without prejudice. Each party shall bear its own costs and attorneys’ fees. |
| Genzyme Corp. v. Fresenius Kabi USA, LLC, 18-1934 (D. Del.) | Mozobil® (plerixafor for injection) | 7,897,590 6,987,102 | Fresenius Kabi is enjoined from making, having made, using, selling, offering to sell and/or importing in or into the US any product under ANDA No. 212395. All claims are dismissed with prejudice. Each party shall bear its own costs and attorneys’ fees. The parties each expressly waive any right to appeal. |
| Arena Pharms., Inc. v. Teva Pharms. USA, Inc., 17-0231 (D. Del.) | Belviq XR® (lorcaserin HCl tablets) | 6,953,787 7,514,422 7,977,329 8,207,158 8,273,734 8,546,379 8,575,149 8,999,970 9,169,213 | Teva has infringed the patents-in-suit by filing ANDA No. 209918. Except as permitted by the Settlement Agreement, Teva is enjoined from making, having made, using, selling, offering to sell, importing or distributing any lorcaserin HCl product pursuant to ANDA No. 209918, until any grant of license to the patents-in-suit provided in the Settlement Agreement to Teva becomes effective. All claims and counterclaims, affirmative defenses and demands are dismissed without prejudice and without costs, disbursements or attorneys’ fees. The parties each expressly waive any right to appeal. |
| Apotex Inc. v. Symplmed Pharms., LLC, 17-0276 (D. Del.) | Prestalia® (perindopril arginine / amlodipine besylate oral tablets) | 6,696,481 7,846,961 | Defendants grant to Apotex a non-exclusive license to manufacture, import, offer for sale, and sell the Apotex ANDA Product in the U.S. as of the date, and upon the terms, set forth in the Confidential License Agreement. Apotex’s action is dismissed with prejudice. |
| Delcor Asset Corp. v. Glenmark Pharms. Ltd., 17-1653 (D. Del.) | Evoclin® (clindamycin phosphate aerosol, foam) | 7,141,237 7,374,747 | All claims, defenses, and counterclaims between the parties are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses. |
| Biogen MA Inc. v. Sun Pharma Global FZE, 17-0848 (D. Del.) | Tecfidera® (dimethyl fumarate delayed-release capsules) | 8,399,514 | N/A |
| Pharmacyclics LLC v. Shilpa Medicare Ltd., 18-0237 (D. Del.) | Imbruvica® (ibrutinib tablets) | 9,296,753 9,725,455 8,999,999 9,801,881 9,801,883 | No party admits liability. Each party shall bear its own costs, attorney fees, and expenses. Plaintiffs’ claims against Defendant are dismissed without prejudice. Defendant’s claims against Plaintiffs are dismissed without prejudice. |
| Shionogi Inc. v. Aurobindo Pharma Ltd., 17-0072 (D. Del.) | Fortamet® (metformin extended-release tablets) | 6,790,459 6,866,866 | All claims dismissed with prejudice. Each party to bear its own costs, expenses, and attorneys’ fees. |
| Novo Nordisk Inc. v. Teva Pharms. USA, Inc., 17-0227 (D. Del.) | Victoza® (liraglutide recombinant solution injection) | 6,268,343 8,114,833 8,846,618 9,265,893 RE41,956 | The patents-in-suit are infringed by any unlicensed manufacture, sale, offer for sale, use, or importation in the United States of the generic product that is subject of Teva’s ANDA. Teva will be enjoined until expiration of patents-in-suit from making, using, offering to sell, selling, or importing into the US the Teva ANDA Product. Teva shall be entitled to contest the infringement, validity and/or enforceability of the patents-in-suit in any future litigation over the patents-in-suit pertaining to any product that is not the Teva Product. Each party will bear its own attorneys’ fees and costs. |
| Novartis Pharms. Corp. v. West-ward Pharms. Int’l Ltd., 14-1196, -1508, 15-0128 (D. Del.) | Afinitor® (everolimus tablets) | 5,665,772 7,297,703 7,741,338 6,004,973 6,239,124 6,455,518 | Parties stipulate and agree that all claims and counterclaims and affirmative defenses are dismissed without prejudice, and without costs, disbursements or attorneys’ fees to any party. |
| Adare Pharms., Inc. v. Teva Pharms. Int’l GMBH, 18-1079 (D. Del.) | Amrix® (cyclobenzaprine HCl extended-release capsules) | 9,399,025 9,375,410 | All claims asserted by Plaintiffs against Inventia are hereby dismissed with prejudice, and all counterclaims asserted by Inventia are hereby dismissed without prejudice. Each party to bear its own costs, attorneys’ fees, and expenses. |
| Astellas Pharma Inc. v. Aurobindo Pharma Ltd., 16-0942 (D. Del.) | Myrbetriq® (mirabegron extended-release tablets) | 7,342,117 7,982,049 8,835,474 RE44,872 | All claims and counterclaims dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. Court shall retain jurisdiction over the settlement agreement in this case. |
| Sun Pharm. Indus. Ltd. v. Novartis Pharms. Corp., 19-0276 (D.N.J.) | Jadenu® (deferasirox tablets) | 9,283,209 | Sun voluntarily dismisses, without prejudice, its complaint. All parties shall pay their own costs, including attorneys’ fees. |
| Novartis Pharms. Corp. v. Teva Pharms. USA, Inc., 18-1039 (D. Del.) | Gilenya® (fingolimod capsules) | 9,187,405 | N/A |
| Valeant Pharms. North America LLC v. Macleods Pharms. Ltd., 18-14204 (D.N.J.) | Jublia® (efinaconazole topical solution) | 7,214,506 8,039,494 8,486,978 9,302,009 9,566,272 9,662,394 9,861,698 9,877,955 | The patents-in-suit are infringed by Macleods’s ANDA product. Macleods will be enjoined until expiration of patents-in-suit from making, using, offering to sell, selling, or importing into the US its ANDA Product. Macleods shall be entitled to contest the infringement, validity and/or enforceability of the patents-in-suit in any future litigation over the patents-in-suit pertaining to any product that is not the Macleods Product. Each party will bear its own attorneys’ fees and costs. |
| Purdue Pharma L.P. v. Ascent Pharms., Inc., 18-0855 (D. Del.) | OxyContin® (oxycodone HCl extended-release tablets) | 9,060,976 9,073,933 9,522,919 9,147,533 9,861,582 8,309,060 9,675,610 | All claims and counterclaims are dismissed with prejudice. No right, written or oral license or sublicense, covenant not to sue, waiver or release or other written or oral authorization is or has been granted or implied by this Stipulated Dismissal. The Action is hereby dismissed without costs or attorney’s fees, save that the Court shall retain jurisdiction over the Action, including without limitation, over implementation of, or disputes arising out of, this Stipulated Dismissal or the settlement of the Action. |
| Celgene Corp. v. Lotus Pharm. Co., Ltd., 18-11518 (D.N.J.) | Revlimid® (lenalidomide capsules) | 7,977,357 8,193,219 8,431,598 | Lotus is enjoined from infringing the patents-in-suit until their expiration, unless authorized by Celgene. All claims, counterclaims, affirmative defenses and demands in this action are hereby dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party. Nothing prohibits Lotus from maintaining any “Paragraph IV Ccrtiflcation” pursuant to 21 U.S.C. § 355G)(2)(A)(vii)(IV) or pursuant to 21 C.F.R. § 31 4.94(a)( 12) with respect to the Patents-in-Suit. Nothing herein restricts or is intended to restrict the FDA from approving Lotus’s ANDA application. |
| In re: copaxone patent litigation, C.A. 16-1267 (D. Del.) | Copaxone® (glatiramer acetate injection) | 9,155,775 9,763,993 | Plaintiff Teva and Defendants Sandoz and Momenta dismiss with prejudice all calims and counterclaims against each other in this action. Each party to bear its own costs and fees. The Court shall retain jurisdiction to enforce the terms and conditions of this dismissal and the agreement and any disputes that may arise thereunder. |
| Approval Date | Reference Listed Drug | Generic Drug Name | NDA Holder | ANDA Applicant |
|---|---|---|---|---|
| 1/2/2019 | Mirapex ER | Pramipexole Dihydrochloride | Boehringer Ingelheim | Alembic Pharms |
| 1/3/2019 | Latuda | Lurasidone HCl | Sunovion | Amneal |
| 1/3/2019 | Latuda | Lurasidone HCl | Sunovion | Invagen Pharms |
| 1/3/2019 | Latuda | Lurasidone HCl | Sunovion | Lupin |
| 1/3/2019 | Latuda | Lurasidone HCl | Sunovion | Accord Hlthcare |
| 1/3/2019 | Aubagio | Teriflunomide | Sanofi Aventis | Sandoz |
| 1/3/2019 | Dolophine | Methadone HCl | West-Ward Pharms | Ascent Pharms |
| 1/4/2019 | Naproxen Sodium | Naproxen Sodium (OTC) | Bionpharma | Catalent |
| 1/4/2019 | Latuda | Lurasidone HCl | Sunovion | Sun Pharma |
| 1/4/2019 | Rythmol SR | Propafenone HCl | GlaxoSmithKline | Sinotherapeutics |
| 1/7/2018 | Abilify | Aripiprazole | Otsuka | Zydus |
| 1/7/2018 | Zytiga | Abiraterone Acetate | Janssen | Amneal |
| 1/7/2018 | Picato | Ingenol Mebutate | Leo Labs | Perrigo UK Finco |
| 1/7/2018 | Aubagio | Teriflunomide | Sanofi Aventis | Accord Healthcare |
| 1/8/2019 | Exelon | Rivastigmine | Novartis | Amneal |
| 1/8/2019 | CellCept | Mycophenolate Mofetil | Roche | Concord Biotech |
| 1/9/2019 | Picato | Ingenol Mebutate | Leo Labs | Perrigo |
| 1/9/2019 | Medrol | Methylprednisolone | Pharmacia and Upjohn | RiconPharma |
| 1/10/2019 | Benicar | Olmesartan Medoxomil | Daiichi Sankyo | Qilu Pharm |
| 1/10/2019 | Fluoxetine HCl | Fluoxetine HCl | Alvogen | Sciegen |
| 1/11/2019 | Caduet | Amlodipine Besylate / Atorvastatin Calcium | Pfizer | Zydus |
| 1/11/2019 | Betamethasone Dipropionate | Betamethasone Dipropionate | Fougera | Zydus |
| 1/11/2019 | Zovirax | Acyclovir | Bausch & Lomb | Torrent |
| 1/11/2019 | Femara | Letrozole | Novartis | Eugia Pharma |
| 1/14/2019 | Viramune | Nevirapine | Boehringer Ingelheim | MacLeods |
| 1/14/2019 | Microzide | Hydrochlorothiazide | Allergan Sales | Sciegen |
| 1/14/2019 | Busulfex | Busulfan | Otsuka | Nexus Pharms |
| 1/14/2019 | Lotronex | Alosetron HCl | Sebela | Rising Pharms |
| 1/14/2019 | Sabril | Vigabatrin | Lundbeck | Teva |
| 1/15/2019 | Relpax | Eletriptan Hydrobromide | Pfizer | Aurobindo |
| 1/15/2019 | Plaquenil | Hydroxychloroquine Sulfate | Concordia Pharms | Laurus Labs |
| 1/16/2019 | Diamox | Acetazolamide | Teva | Xylopia |
| 1/16/2019 | Effient | Prasugrel | Eli Lilly and Co | HEC Pharm |
| 1/16/2019 | Syprine | Trientine HCl | Aton | Navinta |
| 1/17/2019 | Gleevec | Imatinib Mesylate | Novartis | Shilpa Medicare |
| 1/17/2019 | Gleevec | Imatinib Mesylate | Novartis | Wockhardt |
| 1/18/2019 | Precedex | Dexmedetomidine HCl | Hospira | Cipla |
| 1/18/2019 | Prevacid | Lansoprazole | Takeda | Alkem Labs |
| 1/18/2019 | Levo-T / Synthroid / Thyro-Tabs/ Unithroid | Levothyroxine Sodium | Cediprof / AbbVie / Lloyd / Stevens | Lupin |
| 1/18/2019 | Cyclophosphamide | Cyclophosphamide | West-Ward Pharms | Cipla |
| 1/18/2019 | Zovirax | Acyclovir | Bausch & Lomb | Cipla |
| 1/22/2019 | Adderall XR | Dextroamp Saccharate / AMP Aspartate / Dextroamp Sulfate / AMP Sulfate | Shire | Amerigen Pharms |
| 1/22/2019 | Klor-Con | Potassium Chloride | Upsher-Smith Labs | PII |
| 1/22/2019 | Tikosyn | Dofetilde | Pfizer | Aurobindo |
| 1/22/2019 | Retin-A | Tretinoin | Valeant | Taro Pharms |
| 1/23/2019 | Brilinta | Ticagrelor | AstraZeneca | Amneal |
| 1/23/2019 | Brilinta | Ticagrelor | AstraZeneca | Hisun Pharm Hangzhou |
| 1/24/2019 | Trusopt | Dorzolamide HCl | Merck | FDC |
| 1/24/2019 | Suboxone | Buprenorphine HCl / Naloxone HCl | Indivior | Alvogen Pine Brook |
| 1/25/2019 | Aleve PM | Naproxen Sodium / Diphenhydramine Chloride | Bayer Healthcare | Actavis |
| 1/25/2019 | Integrilin | Eptifibatide | Schering | Hainan Poly Pharm |
| 1/25/2019 | Bentyl | Dicyclomine HCl | Allergan | Fresenius Kabi |
| 1/25/2019 | Depo-Provera | Medroxyprogesterone Acetate | Pharmacia and Upjohn | Cipla |
| 1/25/2019 | Retin-A | Tretinoin | Valeant | Taro Pharms |
| 1/25/2019 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride | Alvogen | Dr Reddy's Labs |
| 1/25/2019 | Zanaflex | Tizanidine HCl | Covis Pharma | Alkem Labs |
| 1/25/2019 | Lialda | Mesalamine | Shire | Sun Pharm |
| 1/28/2019 | Lactated Ringer's in Plastic Container | Sodium Chloride / Sodium Lactate / Potssium Chloride / Calcium Chloride in Water | Baxter Healthcare | Fresenius Kabi |
| 1/28/2019 | Cleocin T | Clindamycin Phosphate | Pharmacia and Upjohn | Encube Ethicals |
| 1/28/2019 | DDAVP | Desmopressin Acetate | Ferring Pharms | Abhai |
| 1/28/2019 | Wellbutrin XL | Bupropion HCl | Valeant | Graviti Pharms |
| 1/28/2019 | Rapamune | Sirolimus | PF Prism | Novitium Pharma |
| 1/29/2019 | Vazculep | Phenylephrine HCl | West-Ward Pharm / Avadel Legacy | Fresenius Kabi |
| 1/30/2019 | Advair | Wixela Inhub | Glaxo | Mylan |
| 1/30/2019 | Vazculep | Phenylephrine HCl | Avadel Legacy | Fresenius Kabi |
| 1/30/2019 | Desonide | Desonide | Perrigo | Encube Ethicals |
| 1/30/2019 | Onfi | Clobazam | Lundbeck | Micro Labs |
| 1/31/2019 | Vazculep | Phenylephrine HCl | West-Ward Pharm / Avadel Legacy | Sandoz |
| 1/31/2019 | Protopic | Tacrolimus | Leo Pharma | Accord Healthcare |
| 2/1/2019 | Bentyl | Dicyclomine HCl | Allergan | Nexus Pharms |
| 2/1/2019 | Ritalin | Methylphenidate HCl | Novartis | Cediprof |
| 2/4/2019 | Trandate | Labetalol HCl | County Line Pharms | Invatech Pharma |
| 2/4/2019 | Zovirax | Acyclovir | Bausch & Lomb | Perrigo |
| 2/4/2019 | Fetzima | Levomilnacipran HCl | Allergan | Amneal |
| 2/4/2019 | Oxycodone HCl | Oxycodone HCl | Genus Lifesciences | Alkem Labs |
| 2/5/2019 | Adcirca | Tadalafil | Eli Lilly and Co | Aurobindo |
| 2/5/2019 | Adcirca | Tadalafil | Eli Lilly and Co | Hetero |
| 2/5/2019 | Adcirca | Alyq | Eli Lilly and Co | Teva |
| 2/5/2019 | Adcirca | Tadalafil | Eli Lilly and Co | Dr Reddy's Labs |
| 2/5/2019 | Adcirca | Tadalafil | Eli Lilly and Co | Cipla |
| 2/5/2019 | Adcirca | Tadalafil | Eli Lilly and Co | Ajanta Pharma |
| 2/5/2019 | Adcirca | Tadalafil | Eli Lilly and Co | Lupin |
| 2/5/2019 | Vivelle-Dot | Estradiol | Novartis | Amneal |
| 2/6/2019 | Seasonale | Sylevia | Teva | Sun Pharm |
| 2/7/2019 | Tegretol-XR | Carbamazepine | Novartis | Zydus |
| 2/7/2019 | Nicorette | Nicotine Polacrilex | GlaxoSmithKline | PLD Acquisitions |
| 2/7/2019 | Benicar HCT | Olmesartan Medoxomil / Hydrochlorothiazide | Daiichi Sankyo | Accord Healthcare |
| 2/7/2019 | Oxycodone HCl | Oxycodone HCl | Genus Lifesciences / VistaPharm | Alkem Labs |
| 2/8/2019 | Renagel | Sevelamer HCl | Genzyme | Glenmark |
| 2/8/2019 | Gleevec | Imatinib Mesylate | Novartis | Breckenridge |
| 2/8/2019 | Gleevec | Imatinib Mesylate | Novartis | Amneal |
| 2/8/2019 | Ferriprox | Deferiprone | Apopharma | Taro Pharm |
| 2/8/2019 | Syprine | Trientine HCl | Aton | Amneal |
| 2/8/2019 | Colcrys | Colchicine | Takeda | Alkem Labs |
| 2/8/2019 | Fluoxetine HCl | Fluoxetine HCl | Alvogen | Lupin |
| 2/8/2019 | Lipitor | Atorvastatin Calcium | Pfizer | MSN Labs |
| 2/11/2019 | Dyazide | Triamterene and Hydrochlorothiazide | GlaxoSmithKline | Zydus |
| 2/11/2019 | Omeprazole | Omeprazole (OTC) | Dexcel Pharma | Apotex |
| 2/11/2019 | Triamcinolone Acetonide | Triamcinolone Acetonide | Mylan | Strides Pharma |
| 2/11/2019 | Bentyl | Dicyclomine HCl | Allergan | Custopharm |
| 2/12/2019 | CellCept | Mycophenolate Mofetil | Roche | VistaPharm |
| 2/13/2019 | Vigamox | Moxifloxacin HCl | Novartis | Alembic Pharms |
| 2/13/2019 | Synalar | Fluocinolone Acetonide | Medimetriks Pharms | Encube Ethicals |
| 2/14/2019 | DDAVP | Desmopressin Acetate | Ferring | Luitpold |
| 2/14/2019 | Gemcitabine HCl | Gemcitabine HCl | Hospira | Ingenus Pharms |
| 2/14/2019 | Advil PM | Ibuprofen / Diphenhydramine HCl | Pfizer | Aurobindo Pharma |
| 2/15/2019 | Eloxatin | Oxaliplatin | Sanofi Aventis / Teva | Sun Pharma |
| 2/15/2019 | Actonel | Risedronate Sodium | Apil | Hangzhou Binjiang |
| 2/15/2019 | Olux | Clobetasol Propionate | Mylan | Glenmark |
| 2/19/2019 | Micardis | Telmisartan | Boehringer Ingelheim | Hisun Pharm Hangzhou |
| 2/19/2019 | Diamox | Acetazolamide | Teva | Alembic Pharms |
| 2/19/2019 | Levo-T / Levoxyl / Synthroid / Unithroid | Levothyroxine Sodium | Cediprof / King Pharms / AbbVie / Stevens | Amneal |
| 2/19/2019 | Marcaine | Bupivacaine HCl | Hospira | Novocol Healthcare |
| 2/19/2019 | Colcrys | Colchicine | Takeda | Zydus |
| 2/19/2019 | Zarontin | Ethosuximide | Parke Davis | Strides |
| 2/20/2019 | Zovirax | Acyclovir | Bausch & Lomb | Perrigo |
| 2/20/2019 | Nimbex | Cisatracurium Besylate Preservative Free | AbbVie | Somerset Theraps |
| 2/20/2019 | Mephyton | Phytonadione | Bausch & Lomb | Zydus |
| 2/21/2019 | Rocaltrol | Calcitriol | Validus Pharms | Sun Pharm |
| 2/21/2019 | Abilify | Aripiprazole | Otsuka | Alkem Labs |
| 2/21/2019 | Aromasin | Exemestane | Pharmacia and Upjohn | Breckenridge |
| 2/22/2019 | Niaspan | Niacin | AbbVie | Mylan |
| 2/22/2019 | Antivert | Meclizine HCl | Casper Pharma | Indicus Pharma |
| 2/22/2019 | Gemzar | Gemcitabine HCl | Eli Lilly and Co | Shilpa Medicare |
| 2/22/2019 | Medrol | Methylprednisolone | Pharmacia and Upjohn | Lupin |
| 2/22/2019 | Cyklokapron | Tranexamic Acid | Pharmacia and Upjohn | Acic Pharms |
| 2/22/2019 | Busulfex | Busulfan | Otsuka | Accord Healthcare |
| 2/22/2019 | Benicar | Olmesartan Medoxomil | Daiichi Sankyo | Sunshine Lake |
| 2/22/2019 | Tessalon | Benzonatate | Pfizer | Ascent Pharms |
| 2/22/2019 | Clolar | Clofarabine | Genzyme | Accord Healthcare |
| 2/25/2019 | Flagyl I.V. RTU in Plastic Container / Metro I.V. in Plastic Container / Metronidazole in Plastic Container | Metronidazole in Plastic Container | Baxter Healthcare / B Braun / Hospira | Inforlife |
| 2/25/2019 | Lovaza | Omega-3-Acid Ethyl Esters | SmithKline Beecham | Ascent Pharms |
| 2/25/2019 | Zytiga | Abiraterone Acetate | Janssen | Rising Pharms |
| 2/26/2019 | Zithromax | Azithromycin | Pfizer | Bionpharma |
| 2/26/2019 | Zithromax | Azithromycin | Pfizer | Bionpharma |
| 2/27/2019 | Zytiga | Abiraterone Acetate | Janssen | Wockhardt |
| 2/27/2019 | Vidaza | Azacitidine | Celgene | Lupin |
| 2/27/2019 | Tamiflu | Oseltamivir Phosphate | Roche | Teva |
| 2/28/2019 | Ditropan XL | Oxybutynin Chloride | Janssen | Ajanta |
| 3/1/2019 | Perphenazine | Perphenazine | Sandoz | Rising Pharms |
| 3/1/2019 | Crestor | Rosuvastatin Calcium | IPR | Zydus |
| 3/1/2019 | Gleevec | Imatinib Mesylate | Novartis | Natco Pharma |
| 3/1/2019 | Protonix | Pantoprazole Sodium | Wyeth | Ingenus Pharms |
| 3/4/2019 | Micardis HCT | Telmisartan / Hydrochlorothiazide | Boehringer Ingelheim | Glenmark |
| 3/4/2019 | Exelon | Rivastigmine | Novartis | Zydus |
| 3/4/2019 | Faslodex | Fulvestrant | AstraZeneca | Amneal |
| 3/5/2019 | Epivir | Lamivudine | ViiV Healthcare | Mylan |
| 3/5/2019 | Bepreve | Bepotastine Besilate | Bausch and Lomb | Apotex |
| 3/5/2019 | Nexium 24Hr | Esomeprazole Magnesium | AstraZeneca | Actavis |
| 3/5/2019 | Kapvay | Clonidine HCl | Concordia Pharms | Novast Labs |
| 3/6/2019 | Lipitor | Atorvastatin Calcium | Pfizer | Lupin |
| 3/8/2019 | Tenoretic | Atenolol and Chlorthalidone | Alvogen Malta | Zydus |
| 3/8/2019 | Mestinon | Pyridostigmine Bromide | Bausch | Novitium Pharma |
| 3/11/2019 | Integrilin | Eptifibatide | Schering | USV |
| 3/11/2019 | Micro-K / Micro-K 10 | Potassium Chloride | Nesher Pharms | Zydus |
| 3/11/2019 | Ampyra | Dalfampridine | Acorda | Micro Labs |
| 3/12/2019 | Diovan | Valsartan | Novartis | Alkem |
| 3/12/2019 | Claritin | Loratadine | Bayer Healthcare | Newgen Pharms |
| 3/12/2019 | Zanaflex | Tizanidine HCl | Covis Pharma | RiconPharma |
| 3/12/2019 | Procardia XL | Nifedipine | Pfizer | Novast Labs |
| 3/12/2019 | Zyloprim | Allopurinol | Casper Pharma | Unichem Labs |
| 3/12/2019 | Desonide | Desonide | Perrigo | Teligent Pharma |
| 3/13/2019 | Yasmin | Kemeya | Bayer Healthcare | Sun Pharm |
| 3/13/2019 | Sodium Chloride 3% in Plastic Container | Sodium Chloride 3% in Plastic Container | Baxter Healthcare | Fresenius Kabi |
| 3/13/2019 | Children's Zyrtec | Cetirizine HCl | J and J Consumer | Hetero Labs Ltd III |
| 3/14/2019 | Integrilin | Epifibatide | Schering | USV |
| 3/14/2019 | Lovenox | Enoxaparin Sodium | Sanofi Aventis | Amphastar |
| 3/15/2019 | Diovan HCT | Valsartan / Hydrochlorothiazide | Novartis | Zydus |
| 3/15/2019 | Zovirax | Acyclovir | Bausch | Zydua |
| 3/18/2019 | Bepreve | Bepotastine Besilate | Bausch and Lomb | Micro Labs |
| 3/18/2019 | Lidex | Fluocinonide | County Line Pharms | Teligent Pharma |
| 3/19/2019 | Invanz | Ertapenem Sodium | Merck Sharp Dohme | Savior Lifetec |
| 3/19/2019 | Latuda | Lurasidone HCl | Sunovion | Zydus |
| 3/20/2019 | Aggrenox | Aspirin / Dipyridamole | Boehringer Ingelheim | Lannett |
| 3/20/2019 | Naftin | Naftifine HCl | Sebela | Tolmar |
| 3/21/2019 | Epivir-HBV | Lamivudine | GlaxoSmithKline | Annora |
| 3/22/2019 | Tekturna | Aliskiren Hemifumarate | Noden Pharma | Anchen Pharms |
| 3/22/2019 | Daliresp | Roflumilast | AstraZeneca | Micro Labs |
| 3/22/2019 | Makena Preservative Free | Hydroxyprogesterone Caproate | Amag Pharma | Slayback Pharma |
| 3/22/2019 | Yaz | Drospirenone / Ethinyl Estradiol | Bayer Healthcare | Hetero |
| 3/22/2019 | Viagra | Sildenafil Citrate | Pfizer | Lupin |
| 3/25/2019 | Viagra | Sildenafil Citrate | Pfizer | Mylan |
| 3/25/2019 | Nuvigil | Armodafinil | Cephalon | Apotex |
| 3/26/2019 | Baraclude | Entecavir | Bristol-Myers Squibb | Mylan |
| 3/26/2019 | Cialis | Tadalafil | Eli Lilly and Co | Alembic |
| 3/26/2019 | Cialis | Tadalafil | Eli Lilly and Co | Aurobindo |
| 3/26/2019 | Cialis | Tadalafil | Eli Lilly and Co | Zydus |
| 3/26/2019 | Cialis | Tadalafil | Eli Lilly and Co | Sun Pharm |
| 3/26/2019 | Cialis | Tadalafil | Eli Lilly and Co | Accord Healthcare |
| 3/26/2019 | Cialis | Tadalafil | Eli Lilly and Co | Unichem Labs |
| 3/26/2019 | Cialis | Tadalafil | Eli Lilly and Co | Cipla |
| 3/26/2019 | Cialis | Tadalafil | Eli Lilly and Co | Ajanta |
| 3/26/2019 | Cialis | Tadalafil | Eli Lilly and Co | Amneal |
| 3/26/2019 | Cialis | Tadalafil | Eli Lilly and Co | Hetero |
| 3/26/2019 | Cialis | Tadalafil | Eli Lilly and Co | Dr Reddy's Labs |
| 3/26/2019 | Cialis | Tadalafil | Eli Lilly and Co | Qilu Pharm |
| 3/26/2019 | Cialis | Tadalafil | Eli Lilly and Co | Lupin |
| 3/26/2019 | Cialis | Tadalafil | Eli Lilly and Co | Sunshine Lake |
| 3/26/2019 | Cialis | Tadalafil | Eli Lilly and Co | Torrent |
| 3/26/2019 | Adcirca | Tadalafil | Eli Lilly and Co | Torrent |
| 3/26/2019 | Zanaflex | Tizanidine HCl | Covis Pharma | Cadila |
| 3/27/2019 | Zanaflex | Tizanidine HCl | Covis Pharma | Alkem Labs |
| 3/28/2019 | Letairis | Ambrisentan | Gilead | Watson |
| 3/28/2019 | Letairis | Ambrisentan | Gilead | Mylan |
| 3/28/2019 | Letairis | Ambrisentan | Gilead | Zydus |
| 3/28/2019 | Letairis | Ambrisentan | Gilead | Sun Pharm |
| 3/28/2019 | Xyzal Allergy 24Hr | Levocetirizine Dihydrochloride | Sanofi Avenits | Perrigo |
| 3/29/2019 | Cialis | Tadalafil | Eli Lilly and Co | Watson |
| 3/29/2019 | Azilect | Rasagiline Mesylate | Teva | Micro Labs |
| 3/29/2019 | Potassium Chloride | Potassium Chloride | Genus Lifesciences | Pharm Assoc |