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New ANDA Cases
Federal district court cases that are filed pursuant to the Hatch-Waxman Act
Fourth Quarter
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 |
GENERICally Speaking Winter 2021
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GENERICally Speaking Winter 2021
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