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New ANDA Cases

April 28, 2020, 10:00 pm
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Case NameDate FiledJudgeDrugPatent No(s).
Celgene Corp. v. Mylan Pharms. Inc., 20-0003 (N.D.W.V.)Jan. 3, 2020Hon. Irene M. KeeleyRevlimid® (lenalidomide capsules)7,189,740
7,465,800
7,855,217
7,968,569
8,404,717
8,530,498
8,648,095
9,056,120
9,101,621
9,101,622
Exela Pharma Sciences, LLC v. Avadel Legacy Pharms., LLC, 20-0024 (D. Del.)Jan. 7, 2020Hon. Maryellen NoreikaElcys® (cysteine HCl for injection) Nouress™ (cysteine HCl for injection)10,478,453
Celgene Corp. v. Aurobindo Pharma Ltd., 20-0315 (D.N.J.)Jan. 8, 2020Hon. Susan D. WigentonRevlimid® (lenalidomide capsules)7,465,800
7,855,217
7,968,569
8,530,498
8,648,095
9,101,621
9,101,622
Almirall, LLC v. Zydus Pharms. (USA) Inc., 20-0343 (D.N.J.)Jan. 9, 2020Hon. Freda L. WolfsonAczone® (dapsone gel)9,517,219
Almirall, LLC v. Mylan Pharms. Inc., 20-0006 (N.D.W.V.)Jan. 9, 2020Hon. Irene M. KeeleyAczone® (dapsone gel)9,517,219
Amgen Inc. v. Torrent Pharma Inc., 20-0065 (D. Del.)Jan. 16, 2020Hon. Colm F. ConnollyCorlanor® (ivabradine tablets)7,361,649
7,361,650
7,867,996
7,879,842
Merck Sharp & Dohme Corp. v. Actavis Labs. FL, Inc., 20-0534 (D.N.J.)Jan. 16, 2020Hon. Claire C. CecchiDificid® (fidaxomicin tablets)7,906,489
8,586,551
7,378,508
7,863,249
8,859,510
Novartis Pharms. Corp. v. Alembic Pharms. Ltd., 20-0074 (D. Del.)Jan. 17, 2020Hon. Leonard P. StarkEntresto® (sacubitril / valsartan tablets)8,101,659
8,796,331
8,877,938
9,388,134
Amgen Inc. v. Zydus Pharms. (USA) Inc., 20-0075 (D. Del.)Jan. 17, 2020Hon. Colm F. ConnollyCorlanor® (ivabradine tablets)7,361,649
7,361,650
7,867,996
7,879,842
Merck Sharp & Dohme Corp. v. Actavis Labs. FL, Inc., 20-20217 (S.D. Fla.)Jan. 17, 2020Hon. Ursula UngaroDificid® (fidaxomicin tablets)7,906,489
8,586,551
7,378,508
7,863,249
8,859,510
Vanda Pharms. Inc. v. Apotex Inc., 20-0083 (D. Del.)Jan. 21, 2020Hon. Colm F. ConnollyHetlioz® (tasimelteon capsules)10,449,176
Amgen Inc. v. Zydus Pharms. (USA) Inc., 20-0678 (D.N.J.)Jan. 21, 2020Hon. Freda L. WolfsonCorlanor® (ivabradine tablets)7,361,649
7,361,650
7,867,996
7,879,842
Vanda Pharms. Inc. v. Teva Pharms. USA, Inc., 20-0093 (D. Del.)Jan. 22, 2020Hon. Colm F. ConnollyHetlioz® (tasimelteon capsules)10,449,176
Amgen Inc. v. Bionpharma, Inc., 20-0105 (D. Del.)Jan. 23, 2020Hon. Colm F. ConnollyCorlanor® (ivabradine tablets)7,361,649
7,361,650
7,867,996
7,879,842
Relypsa, Inc. v. Alkem Labs. Ltd., 20-0106 (D. Del.)Jan. 23, 2020Hon. Maryellen NoreikaVeltassa® (patiromer sorbitex calcium powder for oral suspension)8,337,824
9,492,476
9,925,212
Merck Sharp & Dohme Corp. v. Sandoz Inc., 20-0783 (D.N.J.)Jan. 23, 2020Hon. Brian R. MartinottiNoxafil® (posaconazole oral suspension)8,263,600
Janssen Products, L.P. v. Zydus Pharms. (USA) Inc., 20-0787 (D.N.J.)Jan. 23, 2020Hon. Freda L. WolfsonPrezista® (darunavir tablets)7,700,645
8,518,987
7,126,015
7,595,408
Amgen Inc. v. Annora Pharma Private Ltd., 20-0122 (D. Del.)Jan. 24, 2020Hon. Colm F. ConnollyCorlanor® (ivabradine tablets)7,361,649
7,361,650
7,867,996
7,879,842
Amgen Inc. v. Centaur Pharms. Private Ltd., 20-0123 (D. Del.)Jan. 24, 2020Hon. Colm F. ConnollyCorlanor® (ivabradine tablets)7,361,649
7,361,650
7,867,996
7,879,842
Novartis Pharms. Corp. v. Apotex Inc., 20-0133 (D. Del.)Jan. 28, 2020Hon. Leonard P. StarkGilenya® (fingolimod capsules)10,543,179
Sucampo Gmbh v. Zydus Pharms. (USA) Inc., 20-0936 (D.N.J.)Jan. 28, 2020Hon. Freda L. WolfsonAmitiza® (lubiprostone capsules)7,795,312
8,026,393
8,338,639
8,779,187
8,748,481
Amgen Inc. v. MSN Pharms., Inc., 20-0137 (D. Del.)Jan. 29, 2020Hon. Colm F. ConnollyCorlanor® (ivabradine tablets)7,361,649
7,361,650
7,867,996
7,879,842
Pfizer Inc. v. Viwit Pharm. Co., Ltd., 20-0160 (D. Del.)Jan. 31, 2020Hon. Colm F. ConnollyChantix® (varenicline tartrate tablets)6,410,550
6,890,927
7,265,119
Silvergate Pharms., Inc. v. CMP Development LLC, 20-0161 (D. Del.)Jan. 31, 2020Hon. Leonard P. StarkQbrelis® (Lisinopril oral solution)9,463,183
9,616,096
9,814,751
10,039,800
10,265,370
10,406,199
GlaxoSmithKline Consumer Healthcare Holdings (US), LLC v. Cipla Ltd., IPR2020-00368 (PTAB)Jan. 31, 2020N/ADymista® (azelastine HCl / fluticasone propionate metered spray)8,163,723
GlaxoSmithKline Consumer Healthcare Holdings (US), LLC v. Cipla Ltd., IPR2020-00369 (PTAB)Jan. 31, 2020N/ADymista® (azelastine HCl / fluticasone propionate metered spray)8,168,620
GlaxoSmithKline Consumer Healthcare Holdings (US), LLC v. Cipla Ltd., IPR2020-00370 (PTAB)Jan. 31, 2020N/ADymista® (azelastine HCl / fluticasone propionate metered spray)9,259,428
GlaxoSmithKline Consumer Healthcare Holdings (US), LLC v. Cipla Ltd., IPR2020-00371 (PTAB)Jan. 31, 2020N/ADymista® (azelastine HCl / fluticasone propionate metered spray)9,901,585
Boehringer Ingelheim Pharms. Inc. v. Mylan Pharms. Inc., 20-0019 (N.D.W.V.)Feb. 5, 2020Hon. Irene M. KeeleyTradjenta® (linagliptin tablets)9,486,526
Boehringer Ingelheim Pharms. Inc. v. Aurobindo Pharma Ltd., 20-0023 (N.D.W.V.)Feb. 5, 2020Hon. John Preston BaileyTradjenta® (linagliptin tablets)9,486,526
Gilead Sciences, Inc. v. Apotex, Inc., 20-0189 (D. Del.)Feb. 7, 2020Hon. Maryellen NoreikaVemlidy® (tenofovir alafenamide tablets) Descovy® (emtricitabine / tenofovir alafenamide tablets) Odefsey® (emtricitabine / rilpivirine / tenofovir alafenamide tablets)7,390,791
7,803,788
8,754,065
9,296,769
American Regent, Inc. v. Pharmacosmos Therapeutics Inc., 20-1350 (D.N.J.)Feb. 7, 2020Hon. Brian R. MartinottiMonoferric® (ferric derisomaltose for injection)8,431,549
10,478,450
Allergan Sales, LLC v. Breckenridge Pharm., Inc., 20-0199 (D. Del.)Feb. 10, 2020Hon. Mitchell S. GoldbergSaphris® (asenapine maleate sublingual tablets)5,763,476
AstraZeneca AB v. Alembic Pharms. Ltd., 20-0202 (D. Del.)Feb. 11, 2020Hon. Richard G. AndrewsTagrisso® (osimertinib mesylate tablets)10,183,020
Vifor (Int’l) AG v. Mylan Labs. Ltd., 20-1647 (D.N.J.)Feb. 14, 2020Hon. Freda L. WolfsonInjectafer® (ferric carboxymaltose for injection)10,519,252
Vifor (Int’l) AG v. Sandoz Inc., 20-1649 (D.N.J.)Feb. 14, 2020Hon. Freda L. WolfsonInjectafer® (ferric carboxymaltose for injection)10,519,252
Vanda Pharms. Inc. v. MSN Pharms. Inc., 20-0235 (D. Del.)Feb. 19, 2020Hon. Colm F. ConnollyHetlioz® (tasimelteon capsules)10,376,487
Astellas US LLC v. Int’l Medication Systems, Ltd., 20-0273 (D. Del.)Feb. 25, 2020Hon. Colm F. ConnollyLexiscan® (regadenoson for injection)8,106,183
RE47,301
8,524,883
Boehringer Ingelheim Pharms. Inc. v. Annora Pharma Private Ltd., 20-0277 (D. Del.)Feb. 25, 2020Hon. Colm F. ConnollyGlyxambi® (empagliflozin / linagliptin tablets)10,258,637
Millennium Pharms., Inc. v. Sun Pharm. Indus. Ltd., 20-0289 (D. Del.)Feb. 27, 2020Hon. Colm F. ConnollyNinlaro® (ixazomib citrate capsules)7,442,830
8,859,504
9,175,017
ViiV Healthcare Co. v. Lupin Ltd., 20-0293 (D. Del.)Feb. 28, 2020Hon. Mitchell S. GoldbergJuluca® (dolutegravir sodium / rilpivirine HCl tablets)9,242,986
10,426,780
Pfizer Inc. v. Zydus Pharms. (USA) Inc., 20-0300 (D. Del.)Feb. 28, 2020Hon. Leonard P. StarkXeljanz® (tofacitinib citrate tablets)6,965,027
7,301,023
RE41,783
Pfizer Inc. v. Zydus Pharms. (USA) Inc., 20-0301 (D. Del.)Feb. 28, 2020Hon. Leonard P. StarkXeljanz XR® (tofacitinib extended-release tablets)6,965,027
7,301,023
RE41,783
Pfizer Inc. v. Zydus Pharms. (USA) Inc., 20-2222 (D.N.J.)Feb. 28, 2020Hon. Freda L. WolfsonXeljanz XR® (tofacitinib extended-release tablets)6,965,027
7,301,023
RE41,783
Pfizer Inc. v. Zydus Pharms. (USA) Inc., 20-2227 (D.N.J.)Feb. 28, 2020Hon. Freda L. WolfsonXeljanz® (tofacitinib citrate tablets)6,965,027
7,301,023
RE41,783
Vanda Pharms. Inc. v. MSN Pharms. Inc., 20-0318 (D. Del.)Mar. 3, 2020Hon. Colm F. ConnollyHetlioz® (tasimelteon capsules)10,449,176
Takeda Pharms. U.S.A., Inc. v. Alkem Labs. Ltd., 20-0325 (D. Del.)Mar. 3, 2020Hon. Richard G. AndrewsColcrys® (colchicine tablets))7,906,519
7,935,731
8,093,298
7,964,648
8,093,297
7,619,004
7,601,758
7,820,681
7,915,269
7,964,647
7,981,938
8,093,296
8,097,655
8,415,395
8,415,396
8,440,721
8,440,722
Encore Dermatology Inc. v. Glenmark Pharms. Ltd., 20-2509 (D.N.J.)Mar. 6, 2020Hon. Kevin McNultyImpoyz® (clobetasol propionate cream)9,956,231
Astellas US LLC v. Gland Pharma Ltd., 20-0347 (D. Del.)Mar. 9, 2020Hon. Colm F. ConnollyLexiscan® (regadenoson for injection)8,106,183
RE47,301
8,524,883
Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 20-2576 (D.N.J.)Mar. 10, 2020Hon. Claire C. CecchiBridion® (sugammadex for injection)RE44,733
Celgene Corp. v. Apotex Inc., 20-2593 (D.N.J.)Mar. 10, 2020Hon. Esther SalasPomalyst® (pomalidomide capsules)10,555,939
Celgene Corp. v. Breckenridge Pharm., Inc., 20-2597 (D.N.J.)Mar. 10, 2020Hon. Esther SalasPomalyst® (pomalidomide capsules)10,555,939
Celgene Corp. v. Hetero Labs Ltd., 20-2601 (D.N.J.)Mar. 10, 2020Hon. Esther SalasPomalyst® (pomalidomide capsules)10,555,939
Celgene Corp. v. Aurobindo Pharma Ltd., 20-2606 (D.N.J.)Mar. 10, 2020Hon. Esther SalasPomalyst® (pomalidomide capsules)10,555,939
Celgene Corp. v. Dr. Reddy’s Labs., Ltd., 20-2607 (D.N.J.)Mar. 10, 2020Hon. Esther SalasPomalyst® (pomalidomide capsules)10,555,939
Celgene Corp. v. Mylan Pharms. Inc., 20-2608 (D.N.J.)Mar. 10, 2020Hon. Esther SalasPomalyst® (pomalidomide capsules)10,555,939
Celgene Corp. v. Teva Pharms. USA, Inc., 20-2614 (D.N.J.)Mar. 10, 2020Hon. Esther SalasPomalyst® (pomalidomide capsules)10,555,939
Bausch Health US, LLC v. Aleor Dermaceuticals Ltd., 20-2735 (D.N.J.)Mar. 12, 2020Hon. Brian R. MartinottiJublia® (efinaconazole topical solution)10,512,640
10,342,875
10,478,601
Bausch Health US, LLC v. Alkem Labs. Ltd., 20-2737 (D.N.J.)Mar. 12, 2020Hon. Brian R. MartinottiJublia® (efinaconazole topical solution)10,512,640
10,342,875
10,478,601
Bausch Health US, LLC v. Aurobindo Pharma USA Inc., 20-2738 (D.N.J.)Mar. 12, 2020Hon. Brian R. MartinottiJublia® (efinaconazole topical solution)10,512,640
10,342,875
10,478,601
Amneal Pharms. LLC v. Cubist Pharms. LLC, IPR2020-00193 (PTAB)Nov. 27, 2019N/ACubicin RF® (daptomycin for injection)9,138,456
Bausch Health US, LLC v. KVK-Tech, Inc., 20-2742 (D.N.J.)Mar. 12, 2020Hon. Brian R. MartinottiJublia® (efinaconazole topical solution)10,512,640
10,342,875
10,478,601
Bausch Health US, LLC v. Lupin Ltd., 20-2744 (D.N.J.)Mar. 12, 2020Hon. Brian R. MartinottiJublia® (efinaconazole topical solution)10,512,640
10,342,875
10,478,601
Bausch Health US, LLC v. Strides Pharma Inc., 20-2746 (D.N.J.)Mar. 12, 2020Hon. Brian R. MartinottiJublia® (efinaconazole topical solution)10,512,640
10,342,875
10,478,601
Bausch Health US, LLC v. Taro Pharms. U.S.A., Inc., 20-2747 (D.N.J.)Mar. 12, 2020Hon. Brian R. MartinottiJublia® (efinaconazole topical solution)10,512,640
10,342,875
10,478,601
Bausch Health US, LLC v. Zydus Pharms. (USA) Inc., 20-2748 (D.N.J.)Mar. 12, 2020Hon. Brian R. MartinottiJublia® (efinaconazole topical solution)10,512,640
10,342,875
10,478,601
Bausch Health US, LLC v. Mylan Pharms. Inc., 20-2749 (D.N.J.)Mar. 12, 2020Hon. Brian R. MartinottiJublia® (efinaconazole topical solution)10,512,640
10,342,875
10,478,601
Merck Sharp & Dohme B.V. v. Gland Pharma Ltd., 20-2750 (D.N.J.)Mar. 12, 2020Hon. Claire C. CecchiBridion® (sugammadex for injection)RE44,733
Merck Sharp & Dohme B.V. v. Teva Pharms. USA, Inc., 20-2751 (D.N.J.)Mar. 12, 2020Hon. Claire C. CecchiBridion® (sugammadex for injection)RE44,733
Braintree Labs., Inc. v. Alkem Labs. Ltd., 20-0362 (D. Del.)Mar. 13, 2020Hon. Colm F. ConnollySuprep® Bowel Prep Kit (sodium sulfate / potassium sulfate / magnesium sulfate oral lavage solution)6,946,149
Merck Sharp & Dohme B.V. v. Lupin Ltd., 20-2786 (D.N.J.)Mar. 13, 2020Hon. Claire C. CecchiBridion® (sugammadex for injection)RE44,733
Merck Sharp & Dohme B.V. v. Mankind Pharma Ltd., 20-2787 (D.N.J.)Mar. 13, 2020Hon. Claire C. CecchiBridion® (sugammadex for injection)RE44,733
6,949,527
Bausch Health US, LLC v. Mylan Pharms. Inc., 20-0046 (N.D.W.V.)Mar. 13, 2020Hon. Irene M. KeeleyJublia® (efinaconazole topical solution)10,512,640
10,342,875
10,478,601
Exela Pharma Sciences, LLC v. Eton Pharms., Inc., 20-0365 (D. Del.)Mar. 16, 2020Hon. Maryellen NoreikaElcys® (cysteine HCl for injection)10,478,453
10,583,155
Merck Sharp & Dohme B.V. v. Fresenius Kabi USA, LLC, 20-2892 (D.N.J.)Mar. 16, 2020Hon. Claire C. CecchiBridion® (sugammadex for injection)RE44,733
Braintree Labs., Inc. v. Alkem Labs. Ltd., 20-2904 (D.N.J.)Mar. 16, 2020Hon. Peter G. SheridanSuprep® Bowel Prep Kit (sodium sulfate / potassium sulfate / magnesium sulfate oral lavage solution)6,946,149
Merck Sharp & Dohme B.V. v. Dr. Reddy’s Labs., Inc., 20-2909 (D.N.J.)Mar. 16, 2020Hon. Claire C. CecchiBridion® (sugammadex for injection)RE44,733
Merck Sharp & Dohme B.V. v. Fisiopharma S.R.L., 20-2964 (D.N.J.)Mar. 17, 2020Hon. Claire C. CecchiBridion® (sugammadex for injection)RE44,733
Merck Sharp & Dohme B.V. v. Sun Pharm. Indus., Inc., 20-3007 (D.N.J.)Mar. 18, 2020Hon. Claire C. CecchiBridion® (sugammadex for injection)RE44,733
Hoffmann-La Roche, Inc. v. Fresenius Kabi USA, LLC, 20-0394 (D. Del.)19-Mar-20Hon. Richard G. AndrewsAlcensa® (alectinib HCl capsules)9,126,931
9,440,922
9,365,514
10,350,214
Merck Sharp & Dohme B.V. v. Zydus Pharms. (USA) Inc., 20-3068 (D.N.J.)Mar. 19, 2020Hon. Claire C. CecchiBridion® (sugammadex for injection)RE44,733
Merck Sharp & Dohme B.V. v. USV Private Ltd., 20-3072 (D.N.J.)Mar. 19, 2020Hon. Claire C. CecchiBridion® (sugammadex for injection)RE44,733
Pharmacyclics LLC v. Sun Pharma Global FZE, 20-0403 (D. Del.)Mar. 20, 2020Hon. Colm F. ConnollyImbruvica® (ibrutinib tablets)10,478,439
Mitsubishi Tanabe Pharma Corp. v. Aurobindo Pharma USA, Inc. 20-3102 (D.N.J.)Mar. 20, 2020Hon. Renee Marie BumbInvokamet XR® (canagliflozin / metformain HCl extended-release tablets)7,943,582
8,513,202
Mitsubishi Tanabe Pharma Corp. v. Aurobindo Pharma USA, Inc. 20-3106 (D.N.J.)Mar. 20, 2020Hon. Freda L. WolfsonInvokamet XR® (canagliflozin / metformain HCl extended-release tablets)7,943,788
8,222,219
8,785,403
Merck Sharp & Dohme B.V. v. Aspiro Pharma Ltd., 20-3112 (D.N.J.)Mar. 20, 2020Hon. Claire C. CecchiBridion® (sugammadex for injection)RE44,733
6,949,527
Merck Sharp & Dohme B.V. v. Sandoz Inc., 20-3117 (D.N.J.)Mar. 20, 2020Hon. Claire C. CecchiBridion® (sugammadex for injection)RE44,733
Cubist Pharms. LLC v. Mylan Pharms Inc., 20-3168 (D.N.J.)Mar. 23, 2020Hon. Brian R. MartinottiCubicin RF® (daptomycin for injection)9,138,456
Novartis Pharms. Corp. v. Lupin Atlantis Holdings, S.A., 20-0415 (D. Del.)Mar. 24, 2020Hon. Leonard P. StarkEntresto® (sacubitril / valsartan tablets)8,101,659
8,796,331
8,877,938
9,388,134
Cubist Pharms. LLC v. Mylan Pharms. Inc., 20-0052 (N.D.W.V.)Mar. 24, 2020Hon. Irene M. KeeleyCubicin RF® (daptomycin for injection)9,138,456
Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 20-3229 (D.N.J.)Mar. 25, 2020Hon. Michael A. ShippSprycel® (dasatinib tablets)7,491,725
Merck Sharp & Dohme B.V. v. Mylan API US LLC, 20-3270 (D.N.J.)Mar. 25, 2020Hon. Claire C. CecchiBridion® (sugammadex for injection)RE44,733
Salix Pharms., Ltd. v. Norwich Pharms., Inc., 20-0430 (D. Del.)Mar. 26, 2020Hon. Richard G. AndrewsXifaxan® (rifaximin tablets)7,045,620
7,612,199
7,902,206
7,906,542
7,915,275
8,158,644
8,158,781
8,193,196
8,309,569
8,518,949
8,642,573
8,741,904
8,829,017
8,835,452
8,853,231
8,946,252
8,969,398
9,271,968
9,421,195
9,629,828
10,314,828
10,335,397
10,456,384
Ferring Pharms. Inc. v. Fresenius Kabi USA, LLC, 20-0431 (D. Del.)Mar. 26, 2020Hon. Maryellen NoreikaFirmagon® (degarelix for injection)9,579,359
9,415,085
8,841,081
9,877,999
8,828,938
Merck Sharp & Dohme B.V. v. MSN Labs. Private Ltd., 20-3314 (D.N.J.)Mar. 26, 2020Hon. Claire C. CecchiBridion® (sugammadex for injection)RE44,733
Mallinckrodt Hospital Products IP Ltd. v. Baxter Healthcare Corp., 20-0434 (D. Del.)Mar. 27, 2020Hon. Leonard P. StarkOfirmev® (acetaminophen for injection)9,399,012
9,610,265
9,987,238
10,383,834
6,992,218
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