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New ANDA Cases
Federal district court cases that are filed pursuant to the Hatch-Waxman Act
Summer 2020
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). |
---|---|---|---|---|
TherapeuticsMD, Inc. v. Teva Pharms. USA, Inc., 20-3485 (D.N.J.) | Apr. 1, 2020 | Hon. Brian R. Martinotti | Imvexxy® (estradiol vaginal inserts) | 9,180,091 9,289,382 10,258,630 10,398,708 10,471,072 |
Merck Sharp & Dohme B.V. v. Mylan Pharms. Inc., 20-0061 (N.D.W.V.) | Apr. 2, 2020 | Hon. Thomas S. Kleeh | Bridion® (sugammadex for injection) | RE44,733 |
Chiesi USA, Inc. v. Hikma Pharms. USA Inc., 20-0484 (D. Del.) | Apr. 8, 2020 | Hon. Leonard P. Stark | Ferriprox® (deferiprone tablets) | 7,049,328 |
Merck Sharp & Dohme B.V. v. Biophore Pharma Inc., 20-3795 (D.N.J.) | Apr. 8, 2020 | Hon. Claire C. Cecchi | Bridion® (sugammadex for injection) | RE44,733 |
Actelion Pharms. Ltd. v. MSN Pharms. Inc., 20-3859 (D.N.J.) | Apr. 9, 2020 | Hon. Renee Marie Bumb | Uptravi® (selexipag tablets) | 7,205,302 8,791,122 9,284,280 |
Eisai R&D Management Co., Ltd. v. Sandoz Inc., 20-3895 (D.N.J.) | Apr. 9, 2020 | Hon. Stanley R. Chesler | Halaven® (eribulin mesylate for injection) | RE46,965 |
Purdue Pharma L.P. v. Intellipharmaceutics Int’l Inc., 20-0515 (D. Del.) | Apr. 15, 2020 | Hon. Richard G. Andrews | OxyContin® (oxycodone HCl extended-release tablets) | 10,407,434 10,369,109 |
Astellas US LLC v. Glenmark Pharms. Ltd., 20-0516 (D. Del.) | Apr. 15, 2020 | Hon. Colm F. Connolly | Lexiscan® (regadenoson for injection) | 8,106,183
RE 47,301 8,524,883 |
Pharmacyclics LLC v. Zydus Worldwide DMCC, 20-0560 (D. Del.) | Apr. 24, 2020 | Hon. Colm F. Connolly | Imbruvica® (ibrutinib tablets) | 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 9,725,455 10,010,507 10,106,548 10,125,140 10,213,386 10,478,439 |
Tris Pharma, Inc. v. Teva Pharms. USA, Inc., 20-5212 (D.N.J.) | Apr. 28, 2020 | Hon. Kevin McNulty | QuilliChew ER® (methylphenidate HCl extended-release tablets) | 9,545,399 9,844,544 9,844,545 |
TherapeuticsMD, Inc. v. Amneal Pharms., Inc., 20-5256 (D.N.J.) | Apr. 29, 2020 | Hon. Freda J. Wolfson | Bijuva® (estradiol / progesterone capsules) | 8,633,178 8,846,648 8,846,649 8,987,237 8,993,548 8,993,549 9,006,222 9,114,145 9,114,146 9,301,920 10,052,386 10,206,932 |
Bausch Health Ireland Ltd. v. Perrigo Israel Pharms. Ltd., 20-5426 (D.N.J.) | 1-May-20 | Hon. Michael A. Shipp | Bryhali® (halobetasol propionate lotion) | 8,809,307 10,478,502 |
Bayer Intellectual Property Gmbh v. Unichem Inc., 20-5439 (D.N.J.) | 1-May-20 | Hon. Madeline Cox Alreo | Xarelto® (rivaroxaban tablets) | 7,157,456 9,539,218 |
Genentech, Inc. v. Intermune, Inc., 20-0624 (D. Del.) | 8-May-20 | 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 8,318,780 8,420,674 8,592,462 8,609,701 |
Boehringer Ingelheim Pharms. Inc. v. Mylan Pharms. Inc., 20-0090 (N.D.W.V.) | 8-May-20 | Hon. Irene M. Keeley | Jentadueto® (linagliptin / metformin tablets) | 9,415,016 10,022,379 |
Teva Pharms. Int’l Gmbh v. Aurobindo Pharma, Ltd., 20-0632 (D. Del.) | 11-May-20 | Hon. Colm F. Connolly | Bendeka® (bendamustine HCl injection) | 8,609,707 9,265,831 9,572,796 9,572,797 9,034,908 9,144,568 9,572,887 9,597,397 9,597,398 9,597,399 9,000,021 9,579,384 10,010,533 10,052,385 |
Exelixis, Inc. v. MSN Labs. Private Ltd., 20-0633 (D. Del.) | 11-May-20 | Hon. Richard G. Andrews | Cabometyx® (cabozantinib tablets) | 7,579,473 8,497,284 |
Exela Pharma Sciences, LLC v. Sandoz, Inc., 20-0645 (D. Del.) | 14-May-20 | Hon. Maryellen Noreika | Elcys® (cysteine HCl injection) | 10,478,453 10,583,155 |
Sanofi-Aventis U.S. LLC v. MSN Pharms., Inc., 20-0646 (D. Del.) | 14-May-20 | Hon. Richard G. Andrews | Jevtana® Kit (cabazitaxel injection) | 10,583,110 |
Exela Pharma Sciences, LLC v. Sandoz, Inc., 20-1393 (D. Col.) | 15-May-20 | Hon. Michael E. Hegarty | Elcys® (cysteine HCl injection) | 10,478,453 10,583,155 |
Eton Pharms., Inc. v. Exela Pharma Sciences, LLC, PGR2020-00064 (PTAB) | 19-May-20 | N/A | Elcys® (cysteine HCl injection) | 10,478,453 |
Millennium Pharms., Inc. v. Baxter Healthcare Corp., 20-0682 (D. Del.) | 20-May-20 | Hon. Colm F. Connolly | Velcade® (bortezomib for injection) | 6,713,446 6,958,319 |
Vifor Fresenius Medical Care Renal Pharma Ltd. v. Lupin Atlantis Holdings SA, 20-0697 (D. Del.) | 26-May-20 | Hon. Maryellen Noreika | Velphoro® (sucroferric oxyhydroxide chewable tablets) | 10,624,855 |
Boehringer Ingelheim Pharms. Inc. v. HEC Pharm Co., Ltd., 20-2545 (E.D. Pa.) | 29-May-20 | Hon. Wendy Beetlestone | Tradjenta® (linagliptin tablets) Jentadueto® (linagliptin / metformin tablets) | 9,415,016 10,022,379 10,034,877 |
Eisai R&D Management Co., Ltd. v. Shilpa Medicare Ltd., 20-6729 (D.N.J.) | 1-Jun-20 | Hon. Freda L. Wolfson | Lenvima® (lenvatinib mesylate capsules) | 9,006,256 |
Novo Nordisk Inc. v. Sandoz Inc., 20-0747 (D. Del.) | 3-Jun-20 | Hon. Colm F. Connolly | Victoza® (liraglutide recombinant solution injection) | 6,268,343 7,762,994 8,114,833 8,579,869 8,846,618 9,265,893 |
Merck Sharp & Dohme Corp. v. Apotex Inc., 20-0749 (D. Del.) | 3-Jun-20 | Hon. Richard G. Andrews | Janumet XR® (metformin HCl / sitagliptin phosphate extended-release tablets) | 7,326,708 |
Silvergate Pharms., Inc. v. Annora Pharma Private Ltd., 20-0753 (D. Del.) | 4-Jun-20 | Hon. Leonard P. Stark | Epaned® (enalapril powder for oral solution) | 9,669,008 9,808,442 10,039,745 10,154,987 |
United Therapeutics Corp. v. Liquidia Technologies, Inc., 20-0755 (D. Del.) | 4-Jun-20 | Hon. Richard G. Andrews | Tyvaso® (treprostinil inhalation solution) | 9,593,066 9,604,901 |
Novo Nordisk Inc. v. Sandoz Inc., 20-6842 (D.N.J.) | 4-Jun-20 | Hon. Renee Marie Bumb | Victoza® (liraglutide recombinant solution injection) | 6,268,343 7,762,994 8,114,833 8,579,869 8,846,618 9,265,893 |
Sanofi-Aventis U.S. LLC v. Mylan Labs. Ltd., 20-0761 (D. Del.) | 5-Jun-20 | Hon. Richard G. Andrews | Jevtana® Kit (cabazitaxel injection) | 10,583,110 |
Slayback Pharma LLC v. Sumitomo Dainippon Pharma Co., Ltd., IPR2020-01053 (PTAB) | 5-Jun-20 | N/A | Latuda® (lurasidone HCl tablets) | 9,815,827 |
Genus Lifesciences Inc. v. Lannett Co., Inc., 20-0770 (D. Del.) | 8-Jun-20 | Hon. Leonard P. Stark | Goprelto® (cocaine HCl nasal solution) Numbrino® (cocaine HCl nasal solution) | 9,867,815 10,016,407 10,420,760 |
Eton Pharms., Inc. v. Exela Pharma Sciences, LLC, PGR2020-000068 (PTAB) | 8-Jun-20 | N/A | Elcys® (cysteine HCl injection) | 10,583,155 |
Merck Sharp & Dohme Corp. v. Lupin Ltd., 20-0776 (D. Del.) | 9-Jun-20 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate tablets) Janumet XR® (metformin HCl / sitagliptin phosphate extended-release tablets) | 7,326,708 |
Bial – Portela & CA S.A. v. Hetero Labs Ltd., 20-0780 (D. Del.) | 9-Jun-20 | Hon. Colm F. Connolly | Aptiom® (esclicarbazepine acetate tablets) | 10,675,287 |
Bial – Portela & CA S.A. v. Torrent Pharms. Ltd., 20-0781 (D. Del.) | 9-Jun-20 | Hon. Colm F. Connolly | Aptiom® (esclicarbazepine acetate tablets) | 10,675,287 |
Bial – Portela & CA S.A. v. Lupin Ltd., 20-0782 (D. Del.) | 9-Jun-20 | Hon. Colm F. Connolly | Aptiom® (esclicarbazepine acetate tablets) | 10,675,287 |
Bial – Portela & CA S.A. v. Jubilant Life Sciences Ltd., 20-0783 (D. Del.) | 9-Jun-20 | Hon. Colm F. Connolly | Aptiom® (esclicarbazepine acetate tablets) | 10,675,287 |
Bial – Portela & CA S.A. v. Dr. Reddy’s Labs., Ltd., 20-0784 (D. Del.) | 9-Jun-20 | Hon. Colm F. Connolly | Aptiom® (esclicarbazepine acetate tablets) | 10,675,287 |
Bial – Portela & CA S.A. v. Apotex Inc., 20-0785 (D. Del.) | 9-Jun-20 | Hon. Colm F. Connolly | Aptiom® (esclicarbazepine acetate tablets) | 10,675,287 |
Bial – Portela & CA S.A. v. Alkem Labs. Ltd., 20-0786 (D. Del.) | 9-Jun-20 | Hon. Colm F. Connolly | Aptiom® (esclicarbazepine acetate tablets) | 10,675,287 |
Astellas US LLC v. USV Private Ltd., 20-0793 (D. Del.) | 11-Jun-20 | Hon. Colm F. Connolly | Lexiscan® (regadenoson for injection) | 8,106,183 RE47,301 8,524,883 |
Dr. Reddy’s Labs., Inc. v. Merck Sharp & Dohme Corp., IPR2020-01060 (PTAB) | 11-Jun-20 | N/A | Januvia® (sitagliptin phosphate tablets) Janumet® (metformin HCl / sitagliptin phosphate tablets) Janumet® XR (metformin HCl / sitagliptin phosphate extended-release tablets) Juvisync® (simvastatin / sitagliptin phosphate tablets) Steglujan® (ertugliflozin / sitagliptin phosphate tablets) | 7,326,708 |
Sanofi-Aventis U.S. LLC v. Accord Healthcare Inc., 20-0803 (D. Del.) | 12-Jun-20 | Hon. Richard G. Andrews | Jevtana® Kit (cabazitaxel injection) | 10,583,110 |
Sanofi-Aventis U.S. LLC v. Actavis LLC, 20-0804 (D. Del.) | 12-Jun-20 | Hon. Richard G. Andrews | Jevtana® Kit (cabazitaxel injection) | 10,583,110 |
Sun Pharm. Indus. Ltd. Inc. v. Merck Sharp & Dohme Corp., IPR2020-01072 (PTAB) | 12-Jun-20 | N/A | Januvia® (sitagliptin phosphate tablets) Janumet® (metformin HCl / sitagliptin phosphate tablets) Janumet® XR (metformin HCl / sitagliptin phosphate extended-release tablets) Juvisync® (simvastatin / sitagliptin phosphate tablets) Steglujan® (ertugliflozin / sitagliptin phosphate tablets) |
7,326,708 |
Takeda Pharms. U.S.A., Inc. v. Granules Pharms., Inc., 20-0812 (D. Del.) | 16-Jun-20 | Hon. Richard G. Andrews | Colcrys® (colchicine tablets) | 7,906,519 7,935,731 7,964,648 8,093,297 8,093,298 |
Merck Sharp & Dohme Corp. v. Ajanta Pharma Ltd., 20-0815 (D. Del.) | 17-Jun-20 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate tablets) | 7,326,708 |
Takeda Pharms. U.S.A., Inc. v. Dr. Reddy’s Labs., Ltd., 20-0845 (D. Del.) | 24-Jun-20 | Hon. Richard G. Andrews | Colcrys® (colchicine tablets) | 7,906,519 7,935,731 7,964,648 8,093,297 8,093,298 |
Merck Sharp & Dohme Corp. v. Dr. Reddy’s Labs., Inc., 20-0847 (D. Del.) | 24-Jun-20 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate tablets) Janumet® (metformin HCl / sitagliptin phosphate tablets) | 7,326,708 |
Merz Pharms., LLC v. Granules Pharms., Inc., 20-0848 (D. Del.) | 24-Jun-20 | Hon. Richard G. Andrews | Cuvposa® (glycopyrrolate oral solution) | 7,638,552 7,816,396 |
Celgene Corp. v. Cipla Ltd., 20-7759 (D.N.J.) | 24-Jun-20 | Hon. Susan D. Wigenton | Revlimid® (lenalidomide capsules) | 7,465,800 7,855,217 7,968,569 8,530,498 8,648,095 9,101,621 9,101,622 7,189,740 8,404,717 9,056,120 |
Bristol-Myers Squibb Co. v. Lupin Ltd., 20-0854 (D. Del.) | 25-Jun-20 | Hon. Colm F. Connolly | Sprycel® (dasatinib tablets) | 7,491,725 8,680,103 |
Bristol-Myers Squibb Co. v. Lupin Ltd., 20-7810 (D.N.J.) | 25-Jun-20 | Hon. Michael A. Shipp | Sprycel® (dasatinib tablets) | 7,491,725 8,680,103 |
Supernus Pharms., Inc. v. Apotex Inc., 20-7870 (D.N.J.) | 26-Jun-20 | Hon. Freda L. Wolfson | Oxtellar XR® (oxcarbazepine extended-release tablets) |
7,722,898 7,910,131 8,617,600 8,821,930 9,119,791 9,351,975 9,370,525 9,855,278 10,220,042 |
Astellas US LLC v. Hospira, Inc., 20-0893 (D. Del.) | 30-Jun-20 | Hon. Colm F. Connolly | Lexiscan® (regadenoson for injection) | 8,106,183 RE 47,301 8,524,883 |
GENERICally Speaking Summer 2020
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