New ANDA Cases - Summer 2021

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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

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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