New ANDA Cases - Summer 2020

Robins Kaplan LLP

[co-author: Haroon Mian]

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).
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

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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