New ANDA Cases

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

Second Quarter

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).
United Therapeutics Corp. v. ANI Pharms., Inc., 21-0489 (D. Del.) Apr. 1, 2021 Hon. Richard G. Andrews Orenitram® (treprostinil extended-release tablets) 7,417,070
7,544,713
8,252,839
8,349,892
8,410,169
8,747,897
9,050,311
9,278,901
9,393,203
9,422,223
9,593,066
9,604,901
EPI Health, LLC v. Perrigo UK Finco Ltd. Partnership, 21-0498 (D. Del.) Apr. 5, 2021 Hon. Colm F. Connolly Rhofade® (oxymetazoline HCl cream) 7,812,049
8,420,688
8,815,929
8,883,838
9,974,773
10,335,391
10,751,325
Azurity Pharms., Inc. v. Amneal Pharms. LLC, 21-8717 (D.N.J.) Apr. 8, 2021 Hon. Freda L. Wolfson Katerzia® (amlodipine oral suspension) 10,695,329
10,799,453
10,894,039
10,952,998
Purdue Pharma L.P. v. Collegium Pharm., Inc., 21-10598 (D. Mass.) Apr. 9, 2021 Hon. F. Dennis Saylor, IV OxyContin® (oxycodone HCl extended-release tablets) Xtampza® ER (oxycodone extended-release capsules) 10,407,434
Boehringer Ingelheim Pharms. Inc. v. Lupin Ltd., 21-0530 (D. Del.) Apr. 13, 2021 Hon. Colm F. Connolly Trijardy® XR (empagliflozin / linagliptin / metformin HCl extended-release tablets) 8,551,957
9,155,705
9,415,016
9,949,998
10,022,379
10,258,637
10,406,172
Duchesnay Inc. v. Hetero Labs Ltd., 21-0538 (D. Del.) Apr. 14, 2021 Hon. Leonard P. Stark Osphena® (ospemifene tablets) 8,642,079
CMP Development, LLC v. Amneal Pharms. LLC, 21-0549 (D. Del.) Apr. 16, 2021 Hon. Maryellen Noreika CaroSpir® (spironolactone oral suspension) 9,757,394
10,493,083
10,624,906
10,660,907
10,888,570
AstraZeneca AB v. Zydus Pharms. (USA), Inc., 21-0550 (D. Del.) Apr. 16, 2021 Hon. Richard G. Andrews Tagrisso® (osimertinib mesylate tablets) 10,183,020
Bayer Pharma AG v. Accord Healthcare Inc., 21-0566 (D. Del.) Apr. 22, 2021 Hon. Richard G. Andrews Xarelto® (rivaroxaban tablets) 10,828,310
Bausch Health Ireland Ltd. v. MSN Labs. Private Ltd., 21-10057 (D.N.J.) Apr. 22, 2021 Hon. Stanley R. Chesler Trulance® (plecanatide tablets) 7,041,786
7,799,897
8,637,451
9,610,321
9,616,097
9,919,024
9,925,231
10,011,637
Otsuka Pharm. Co., Ltd. v. Sandoz Inc., 21-0580 (D. Del.) Apr. 26, 2021 Hon. Leonard P. Stark Rexulti® (brexpiprazole tablets) RE48,059
Celgene Corp. v. Hikma Pharms. USA, Inc., 21-10398 (D.N.J.) Apr. 28, 2021 Hon. Susan D. Wigenton Revlimid® (lenalidomide capsules) 7,189,740
7,465,800
7,855,217
7,968,569
8,404,717
8,530,498
8,648,095
9,056,120
9,101,621
9,101,622
Bausch Health Ireland Ltd. v. Mylan Labs. Ltd., 21-10403 (D.N.J.) Apr. 28, 2021 Hon. Stanley R. Chesler Trulance® (plecanatide tablets) 7,041,786
7,799,897
8,637,451
9,610,321
9,616,097
9,919,024
9,925,231
10,011,637
Bausch Health Ireland Ltd. v. Mylan Labs. Ltd., 21-0611 (D. Del.) Apr. 29, 2021 Hon. Leonard P. Stark Trulance® (plecanatide tablets) 7,041,786
7,799,897
8,637,451
9,610,321
9,616,097
9,919,024
9,925,231
10,011,637
Mayne Pharma LLC v. Perrigo Israel Pharms. Ltd., 21-0612 (D. Del.) Apr. 29, 2021 Hon. Colm F. Connolly Lexette® (halobetasol propionate topical foam) 10,857,159
Bausch Health Ireland Ltd. v. Mylan Labs. Ltd., 21-0573 (W.D. Pa.) Apr. 30, 2021 Hon. W. Scott Hardy Trulance® (plecanatide tablets) 7,041,786
7,799,897
8,637,451
9,610,321
9,616,097
9,919,024
9,925,231
10,011,637
Novartis Pharms. Corp. v. Handa Neuroscience, LLC, 21-0645 (D. Del.) 4-May-21 Hon. Leonard P. Stark Gilenya® (fingolimod tablets) 9,187,405
10,543,179
Novartis Pharms. Corp. v. Handa Neuroscience, LLC, 21-3397 (N.D. Ca.) 6-May-21 Hon. Edward J. Davila Gilenya® (fingolimod tablets) 9,187,405
10,543,179
Amgen Inc. v. Aurobindo Pharma Ltd., 21-0662 (D. Del.) 6-May-21 Hon. Maryellen Noreika Parsabiv® (etelcalcetide for injection) 9,820,938
10,344,765
Astellas Pharma Inc. v. Sandoz Inc., 21-0664 (D. Del.) 7-May-21 Hon. Joseph F. Bataillon Myrbetriq® (mirabegron extended-release tablets) 10,842,780
Astellas US LLC v. American Regent, Inc., 21-0671 (D. Del.) 7-May-21 Hon. Colm F. Connolly Lexiscan® (regadenoson for injection) 8,106,183
RE47,301
8,524,883
Jazz Pharms., Inc. v. Avadel Pharms. PLC, 21-0691 (D. Del.) 12-May-21 Hon. Maryellen Noreika Xyrem® (sodium oxybate oral solution) 8,731,963
10,758,488
10,813,885
10,959,956
10,966,931
Teva Pharms. Int’l GmbH v. Dr. Reddy’s Labs., Ltd., 21-0695 (D. Del.) 13-May-21 Hon. Colm F. Connolly Bendeka® (bendamustine HCl for 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
Melinta Therapeutics, LLC v. Nexus Pharms., Inc., 21-11198 (D.N.J.) 13-May-21 Hon. Brian R. Martinotti Minocin® (minocycline for injection) 9,278,105
9,084,802
Melinta Therapeutics, LLC v. Nexus Pharms., Inc., 21-2636 (N.D. Ill.) 14-May-21 Hon. John F. Kness Minocin® (minocycline for injection) 9,278,105
9,084,802
Bausch Health Ireland Ltd. v. Lupin Ltd., 21-11258 (D.N.J.) 14-May-21 Hon. Renee Marie Bumb Plenvu® (PEG 3350 / sodium ascorbate / sodium sulfate / ascorbic acid / sodium chloride / potassium chloride oral solution) 10,918,723
Celgene Corp. v. Biocon Pharma Ltd., 21-11261 (D.N.J.) 14-May-21 Hon. Susan D. Wigenton Revlimid® (lenalidomide capsules) 7,189,740
7,465,800
7,855,217
7,968,569
8,404,717
8,530,498
8,648,095
9,056,120
9,101,621
9,101,622
Amgen Inc. v. MSN Labs. Private Ltd., 21-0712 (D. Del.) 19-May-21 Hon. Maryellen Noreika Parsabiv® (etelcalcetide for injection) 8,377,880
8,999,932
9,278,995
9,701,712
9,820,938
10,344,765
Bayer Pharma AG v. Dr. Reddy’s Labs., Inc., 21-0732 (D. Del.) 24-May-21 Hon. Richard G. Andrews Xarelto® (rivaroxaban tablets) 10,828,310
Almirall, LLC v. Acrux DDS Pty. Ltd., 21-11948 (D.N.J.) 28-May-21 Hon. Madeline Cox Arleo Aczone® (dapsone gel) 9,517,219
Supernus Pharms., Inc. v. Riconpharma LLC, 21-12133 (D.N.J.) 3-Jun-21 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
Merck Sharp & Dohme Corp. v. Alkem Labs. Ltd., 21-0824 (D. Del.) 4-Jun-21 Hon. Richard G. Andrews Januvia® (sitagliptin phosphate tablets) 7,326,708
Taiho Pharm. Co., Ltd. v. Accord Healthcare Inc., 21-0838 (D. Del.) 9-Jun-21 Hon. Colm F. Connolly Lonsurf® (tipiracil HCl / trifluridine tablets) 10,960,004
Newron Pharms. S.p.A. v. Aurobindo Pharma Ltd., 21-0843 (D. Del.) 10-Jun-21 Hon. Richard G. Andrews Xadago® (safinamide tablets) 8,076,515
8,278,485
8,283,380
Pfizer Inc. v. MSN Pharms. Inc., 21-0858 (D. Del.) 15-Jun-21 Hon. Colm F. Connolly Ibrance® (palbociclib tablets) 10,723,730
Exelixis, Inc. v. Teva Pharm. Indus. Ltd., 21-0871 (D. Del.) 17-Jun-21 Hon. Richard G. Andrews Cabometyx® (cabozantinib s-malate tablets) 9,724,342
10,039,757
10,034,873
Novartis Pharms. Corp. v. Fresenius Kabi USA, LLC, 21-0870 (D. Del.) 17-Jun-21 Hon. Leonard P. Stark Kisqali® (ribociclib tablets) Kisqali® Femara® Co-pack (ribociclib / letrozole tablets) 8,324,225
8,415,355
8,685,980
8,962,630
9,193,732
9,416,136
9,868,739
10,799,506
Apotex Inc. v. Pfizer Inc., IPR2021-01132 (PTAB) 17-Jun-21 N/A Chantix® (varenicline tartrate tablets) 6,890,927
AstraZeneca AB v. Alembic Pharms. Ltd., 21-0875 (D. Del.) 18-Jun-21 Hon. Richard G. Andrews Brilinta® (ticagrelor tablets) 8,425,934
10,300,065
TherapeuticsMD, Inc. v. Teva Pharms. USA, Inc., 21-12794 (D.N.J.) 21-Jun-21 Hon. Brian R. Martinotti Imvexxy® (estradiol vaginal inserts) 10,888,516
Tris Pharma, Inc. v. Ascent Pharms., Inc., 21-12867 (D.N.J.) 22-Jun-21 Hon. Kevin McNulty QuilliChew ER® (methylphenidate HCl extended-release chewable tablets) 8,999,386
9,295,642
9,545,399
9,844,544
Azurity Pharms., Inc. v. Bionpharma Inc., 21-12870 (D.N.J.) 22-Jun-21 Hon. Michael A. Shipp Epaned® (enalapril maleate oral solution) 11,040,023
Otsuka Pharm. Co., Ltd. v. Lupin Ltd., 21-0900 (D. Del.) 23-Jun-21 Hon. Richard G. Andrews Jynarque® (tolvaptan tablets) 8,501,730
10,905,694
Celgene Corp. v. Torrent Pharms. Ltd., 21-12927 (D.N.J.) 23-Jun-21 Hon. Susan D. Wigenton Revlimid® (lenalidomide capsules) 7,189,740
7,465,800
7,855,217
7,968,569
8,404,717
8,530,498
8,648,095
9,056,120
9,101,621
9,101,622
Takeda Pharms. America, Inc. v. Apotex, Inc., 21-12998 (D.N.J.) 25-Jun-21 Hon. Kevin McNulty Iclusig® (ponatinib HCl tablets) 9,493,470
Pfizer Inc. v. Qilu Pharm. Co., Ltd., 21-0929 (D. Del.) 29-Jun-21 Hon. Colm F. Connolly Ibrance® (palbociclib capsules) 10,723,730
Teva Pharms. Int’l GmbH v. Accord Healthcare Inc., 21-0952 (D. Del.) 29-Jun-21 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
Amphastar Pharms. Inc. v. Eli Lilly and Co., 21-1922 (S.D. Ind.) 29-Jun-21 Hon. Richard L. Young Forteo® (teriparatide injection) 7,517,334
Novartis Pharms. Corp. v. Micro Labs Ltd., 21-0969 (D. Del.) 30-Jun-21 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
Astellas Pharma Inc. v. Sandoz Inc., 21-13177 (D.N.J.) 30-Jun-21 Hon. John Michael Vazquez Xtandi® (enzalutamide tablets) 7,709,517
8,183,274
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