New ANDA Cases

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

Summer 2020

Robins Kaplan 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).
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
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