New ANDA Cases - Winter 2021

Robins Kaplan LLP

Federal District Court Cases That Are Filed Pursuant To The Hatch-Waxman Act

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

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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