New ANDA Cases

Federal district court cases that are filed pursuant to the Hatch-Waxman Act

Fourth Quarter

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings before the Patent Trial and Appeal Board concerning Orange Book-listed patents.

Case Name Date Filed Judge Drug Patent No(s).
Otsuka Pharm. Co., Ltd. v. Optimus Pharma Pvt. Ltd., 20-1332 (D. Del.) Oct. 1, 2020 Hon. Leonard P. Stark Rexulti® (brexipiprazole tablets) RE48,059
Vanda Pharms. Inc. v. Apotex Inc., 20-1333 (D. Del.) Oct. 1, 2020 Hon. Colm F. Connolly Hetlioz® (tasimelteon capsules) 10,610,510
10,610,511
Otsuka Pharm. Co., Ltd. v. MSN Pharms. Inc., 20-1334 (D. Del.) Oct. 1, 2020 Hon. Colm F. Connolly Hetlioz® (tasimelteon capsules) 10,610,510
10,610,511
Otsuka Pharm. Co., Ltd. v. Ajanta Pharma Ltd., 20-1335 (D. Del.) Oct. 1, 2020 Hon. Leonard P. Stark Rexulti® (brexipiprazole tablets) RE48,059
UCB, Inc. v. Sunshine Lake Pharma Co., Ltd., 20-1343 (D. Del.) Oct. 2, 2020 Hon. Colm. F. Connolly Briviact® (brivaracetam tablets) 6,784,197
6,911,461
8,492,416
Allergan USA, Inc. v. Hetero Labs Ltd., 20-1344 (D. Del.) Oct. 2, 2020 Hon. Richard G. Andrews Viberzi® (eluxadoline tablets) 7,741,356
Actelion Pharms. Ltd. v. Laurus Labs Ltd., 20-13967 (D.N.J.) Oct. 5, 2020 Hon. Freda L. Wolfson Opsumit® (macitentan tablets) 7,094,781
Almirall, LLC v. Torrent Pharms. Ltd., 20-1373 (D. Del.) Oct. 9, 2020 Hon. Maryellen Noreika Aczone® Gel (dapsone) 9,517,219
Celgene Corp. v. Hetero Labs Ltd., 20-14389 (D.N.J.) Oct. 13, 2020 Hon. Susan D. Wigenton Revlimid® (lenalidomide capsules) 7,977,357
8,193,219
Pfizer Inc. v. Alembic Pharms., Inc., 20-1392 (D. Del.) Oct. 16, 2020 Hon. Colm F. Connolly Ibrance® (palbociclib capsules) 10,723,730
Pfizer Inc. v. Cipla USA Inc., 20-1393 (D. Del.) Oct. 16, 2020 Hon. Colm F. Connolly Ibrance® (palbociclib capsules) 10,723,730
Pfizer Inc. v. Mylan Pharms. Inc., 20-1395 (D. Del.) Oct. 16, 2020 Hon. Colm F. Connolly Ibrance® (palbociclib capsules) 10,723,730
Pfizer Inc. v. Zydus Pharms. (USA) Inc., 20-1396 (D. Del.) Oct. 16, 2020 Hon. Colm F. Connolly Ibrance® (palbociclib capsules) 10,723,730
Pfizer Inc. v. Zydus Pharms. (USA) Inc., 20-14580 (D.N.J.) Oct. 16, 2020 Hon. Renee Marie Bumb Ibrance® (palbociclib capsules) 10,723,730
Pfizer Inc. v. Mylan Pharms. Inc., 20-0244 (N.D.W.V.) Oct. 16, 2020 Hon. Thomas S. Kleeh Ibrance® (palbociclib capsules) 10,723,730
Pfizer Inc. v. Sun Pharm. Indus., Ltd, 20-1407 (D. Del.) Oct. 20, 2020 Hon. Colm F. Connolly Ibrance® (palbociclib capsules) 10,723,730
Pfizer Inc. v. Sun Pharm. Indus., Ltd, 20-14717 (D.N.J.) Oct. 20, 2020 Hon. Renee Marie Bumb Ibrance® (palbociclib capsules) 10,723,730
Dermira, Inc. v. Perrigo Pharma Int’l DAC, 20-1413 (D. Del.) Oct. 21, 2020 Hon. Colm F. Connolly Qbrexza® (glycopyrronium cloth) 8,618,160
9,744,105
10,052,267
8,859,610
9,259,414
10,004,717
10,543,192
10,548,875
Teva Branded Pharm. Products R&D, Inc. v. Aurobindo Pharma Ltd., 20-14833 (D.N.J.) Oct. 22, 2020 Hon. Madeline Cox Arleo Qvar® (beclomethasone dipropionate inhalation aerosol) 9,463,289
9,808,587
10,022,509
10,022,510
10,086,156
10,561,808
10,695,512
Galderma Labs., L.P. v. Zydus Pharms. (USA) Inc., 20-14857 (D.N.J.) Oct. 22, 2020 Hon. Freda L. Wolfson Epiduo® Forte (adapalene / benzoyl peroxide gel) 8,936,800
9,814,690
8,785,420
8,703,820
9,387,187
8,445,543
Otsuka Pharm. Co., Ltd. v. Teva Pharms. USA, Inc., 20-1423 (D. Del.) Oct. 23, 2020 Hon. Leonard P. Stark Rexulti® (brexipiprazole tablets) RE48,059
Novartis Pharms. Corp. v. Aurobindo Pharma Ltd., 20-1426 (D. Del.) Oct. 23, 2020 Hon. Leonard P. Stark Xiidra® (lifitegrast ophthalmic solution) 7,314,938
7,745,460
7,790,743
7,928,122
9,216,174
10,124,000
8,084,047
8,592,450
8,168,655
8,367,701
9,447,077
8,927,574
9,353,088
9,890,141
9,085,553
Otsuka Pharm. Co., Ltd. v. MSN Labs. Pvt. Ltd., 20-1428 (D. Del.) Oct. 23, 2020 Hon. Leonard P. Stark Rexulti® (brexipiprazole tablets) RE48,059
Teva Branded Pharm. Products R&D, Inc. v. Cipla Ltd., 20-14890 (D.N.J.) Oct. 23, 2020 Hon. Madeline Cox Arleo Qvar® (beclomethasone dipropionate inhalation aerosol) 10,695,512
TherapeuticsMD, Inc. v. Amneal Pharms., Inc., 20-14933 (D.N.J.) Oct. 23, 2020 Hon. Freda L. Wolfson Bijuva® (estradiol / progesterone capsules) 10,806,740
Allergan USA, Inc. v. Sun Pharm. Indus. Ltd., 20-1479 (D. Del.) Oct. 29, 2020 Hon. Richard G. Andrews Viberzi® (eluxadoline tablets) 7,741,356
Fresenius Kabi USA, LLC v. Custopharm, Inc., 20-3254 (D. Col.) Oct. 30, 2020 Hon. Michael E. Hegarty levothyroxine sodium for injection 9,782,376
10,398,669
Fresenius Kabi USA, LLC v. Custopharm, Inc., 20-15342 (D.N.J.) Oct. 30, 2020 Hon. Susan D. Wigenton levothyroxine sodium for injection 9,782,376
10,398,669
Fresenius Kabi USA, LLC v. Custopharm, Inc., 20-1091 (D. Col.) Oct. 30, 2020 Hon. Lee Yeakel levothyroxine sodium for injection 9,782,376
10,398,669
Merck Sharp & Dohme Corp. v. Ajanta Pharma Ltd., 20-1496 (D. Del.) Nov. 4, 2020 Hon. Richard G. Andrews Janumet® (sitagliptin phosphate / metformin HCl tablets) 7,326,708
Otsuka Pharm. Co., Ltd. v. Prinston Pharm. Inc., 20-1502 (D. Del.) Nov. 6, 2020 Hon. Leonard P. Stark Rexulti® (brexpiprazole tablets) RE48,059
Pfizer Inc. v. Aurobindo Pharma, Ltd., 20-1528 (D. Del.) Nov. 13, 2020 Hon. Colm F. Connolly Ibrance® (palbociclib capsules) 10,723,730
Pfizer Inc. v. Dr. Reddy’s Labs., Inc., 20-1530 (D. Del.) Nov. 13, 2020 Hon. Colm F. Connolly Ibrance® (palbociclib capsules) 10,723,730
Otsuka Pharm. Co., Ltd. v. Hetero Labs Ltd., 20-1531 (D. Del.) Nov. 13, 2020 Hon. Leonard P. Stark Rexulti® (brexpiprazole tablets) RE48,059
Pfizer Inc. v. Dr. Reddy’s Labs., Inc., 20-16117 (D. Del.) Nov. 13, 2020 Hon. Renee Marie Bumb Ibrance® (palbociclib capsules) 10,723,730
Sanofi-Aventis U.S. LLC v. Hong Kong King-Friend Industrial Co. Ltd., 20-1547 (D. Del.) Nov. 17, 2020 Hon. Richard G. Andrews Jevtana® Kit (cabazitaxel for injection) 10,583,110
10,716,777
Otsuka Pharm. Co., Ltd. v. Aurobindo Pharma Ltd., 20-1581 (D. Del.) Nov. 23, 2020 Hon. Leonard P. Stark Rexulti® (brexpiprazole tablets) RE48,059
Boehringer Ingelheim Pharms. Inc. v. Sun Pharm. Indus. Ltd., 20-1585 (D. Del.) Nov. 23, 2020 Hon. Colm F. Connolly Trijardy XR® (empagliflozin / linagliptin / metformin extended-release tablets) 7,579,449
Astellas Pharma Inc. v. Sandoz Inc., 20-1589 (D. Del.) Nov. 24, 2020 Hon. Joseph F. Bataillon Myrbetriq® (mirabegron extended-release tablets) 10,842,780
Otsuka Pharm. Co., Ltd. v. Zenara Pharma Private Ltd., 20-1599 (D. Del.) Nov. 24, 2020 Hon. Leonard P. Stark Rexulti® (brexpiprazole tablets) RE48,059
Adverio Pharma GmbH v. MSN Labs. Private Ltd., 20-1617 (D. Del.) Nov. 25, 2020 Hon. Leonard P. Stark Adempas® (riociguat tablets) 10,662,188
Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., 20-1630 (D. Del.) Nov. 30, 2020 Hon. Richard G. Andrews Vascepa® (icosapent ethyl capsules) 9,700,537
8,642,077
10,568,861
TherapeuticsMD, Inc. v. Teva Pharms. USA, Inc., 20-17496 (D.N.J.) Nov. 30, 2020 Hon. Brian R. Martinotti Imvexxy® (estradiol vaginal insert) 10,806,697
10,835,487
Eli Lilly and Co. v. Shilpa Medicare Ltd., 20-3132 (S.D. Ind.) Dec. 4, 2020 Hon. Tanya Walton Pratt Alimta® (pemetrexed for injection) 7,772,209
Par Pharm., Inc. v. Eagle Pharms. Inc., 20-18319 (D.N.J.) Dec. 7, 2020 Hon. Brian R. Martinotti Vasostrict® (vasopressin for injection) 10,844,435
Par Pharm., Inc. v. Amneal EU, Ltd., 20-18322 (D.N.J.) Dec. 7, 2020 Hon. Brian R. Martinotti Vasostrict® (vasopressin for injection) 10,844,435
Par Pharm., Inc. v. Dr. Reddy’s Labs., Inc., 20-18328 (D.N.J.) Dec. 7, 2020 Hon. Brian R. Martinotti Vasostrict® (vasopressin for injection) 10,844,435
Par Pharm., Inc. v. Aurobindo Pharma U.S.A., Inc., 20-18334 (D.N.J.) Dec. 7, 2020 Hon. Brian R. Martinotti Vasostrict® (vasopressin for injection) 10,844,435
Merck Sharp & Dohme B.V. v. Teva Pharms. USA, Inc., 20-18972 (D.N.J.) Dec. 14, 2020 Hon. Claire C. Cecchi Bridion® (sugammadex for injection) RE44,733
Acrotech Biopharma LLC v. Alembic Global Holding SA, 20-19295 (D.N.J.) Dec. 15, 2020 Hon. Freda L. Wolfson Evomela® (captisol®-enabled melphalan HCl for injection) 10,864,183
Bausch Health Ireland Ltd. v. Lupin Ltd., 20-19379 (D.N.J.) Dec. 16, 2020 Hon. Renee Marie Bumb Plenvu® (polyethylene glycol / sodium ascorbate / sodium sulfate / ascorbic acid / sodium chloride / potassium chloride oral solution) 10,780,112
10,792,306
Galderma Labs., L.P. v. Zydus Pharms. (USA) Inc., 20-19578 (D.N.J.) Dec. 17, 2020 Hon. Renee Marie Bumb Soolantra® (ivermectin cream) 9,089,587
9,233,117
9,233,118
9,782,425
10,206,939
Merz Pharms., LLC v. Aurobindo Pharma Ltd., 20-1760 (D. Del.) Dec. 23, 2020 Hon. Richard G. Andrews Cuvposa® (glycopyrrolate oral solution) 7,638,552
7,816,396
Otsuka Pharm. Co., Ltd. v. Zydus Pharms. (USA) Inc., 20-1763 (D. Del.) Dec. 23, 2020 Hon. Leonard P. Stark Rexulti® (brexpiprazole tablets) RE48,059
Otsuka Pharm. Co., Ltd. v. Zydus Pharms. (USA) Inc., 20-20269 (D.N.J.) Dec. 23, 2020 Hon. Michael A. Shipp Rexulti® (brexpiprazole tablets) RE48,059
Eagle Pharms., Inc. v. Shilpa Medicare Ltd., 20-20270 (D.N.J.) Dec. 23, 2020 Hon. John Michael Vazquez Pemfexy® (pemetrexed for injection) 9,604,990
Merz Pharms., LLC v. Aurobindo Pharma Ltd., 20-20346 (D.N.J.) Dec. 28, 2020 Hon. Freda L. Wolfson Cuvposa® (glycopyrrolate oral solution) 7,638,552
7,816,396

Oren D. Langer

Partner

Assistant Managing Partner, New York Office
Member of Executive Board

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