New ANDA Cases

November 2019

GENERICally Speaking: A Hatch Waxman Litigation Bulletin
Case Name Date Filed Judge Drug Patent No(s).
Allergan Sales, LLC v. Ajanta Pharma Ltd., 19-1249 (D. Del.) July 2, 2019 Hon. Leonard P. Stark Bystolic® (nebivolol HCl tablets) 6,545,040
Teva Pharms. Int’l Gmbh v. Lupin, Ltd., 19-1251 (D. Del.) July 2, 2019 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
Celgene Corp. v. Cipla Ltd., 19-14731 (D.N.J.) July 3, 2019 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
AstraZeneca LP v. HEC Pharm Co., Ltd., 19-14737 (D.N.J.) July 3, 2019 Hon. Claire C. Cecchi Brilinta® (ticagrelor tablets) RE46,276
7,265,124
Leo Pharma A/S v. Teva Pharms. USA, Inc., 19-1282 (D. Del.) July 9, 2019 Hon. Colm F. Connolly Finacea® (azelaic acid foam) 10,322,085
Boehringer Ingelheim Pharms. Inc. v. Zydus Pharms. (USA) Inc., 19-1295 (D. Del.) July 11, 2019 Hon. Colm F. Connolly Glyxambi® (empagliflozin / linagliptin tablets) 7,579,449
7,713,938
8,551,957
9,949,998
10,258,637
Celgene Corp. v. Dr. Reddy’s Labs., Ltd., 19-15343 (D.N.J.) July 12, 2019 Hon. Esther Salas Pomalyst® (pomalidomide capsules) 8,198,262
8,673,939
8,735,428
8,828,427
9,993,467
Actelion Pharms. Ltd. v. Aurobindo Pharma USA Inc., 19-15437 (D.N.J.) July 16, 2019 Hon. Freda L. Wolfson Opsumit® (macitentan tablets) 7,094,781
Cubist Pharms. LLC v. Amneal Pharms. LLC, 19-15439 (D.N.J.) July 16, 2019 Hon. Brian R. Martinotti Cubicin RF® (daptomycin for injection) 9,138,456
Teijin Ltd. v. Sunshine Lake Pharma Co., Ltd., 19-15448 (D.N.J.) July 16, 2019 Hon. Michael A. Shipp Uloric® (febuxostat tablets) 7,361,676
8,372,872
9,107,912
Celgene Corp. v. Hetero Labs Ltd., 19-15449 (D.N.J.) July 16, 2019 Hon. Susan D. Wigenton Revlimid® (lenalidomide capsules) 7,189,740
7,968,569
8,404,717
8,530,498
8,648,095
9,056,120
9,101,621
9,101,622
Ajanta Pharma Ltd. v. Pfizer Inc., 19-6607 (S.D.N.Y.) July 16, 2019 Hon. Jesse M. Furman Chantix® (varenicline tablets) 6,890,927 7,265,119
UCB, Inc. v. Mylan Technologies, Inc., 19-0128 (D. Vt.) July 16, 2019 Hon. John M. Conroy Neupro® (rotigotine transdermal system) 10,130,589 10,350,174
Eisai Co., Ltd. v. Lupin Ltd., 19-1336 (D. Del.) July 17, 2019 Hon. Leonard P. Stark Banzel® (rufinamide oral suspension) 6,740,669
Alkermes Pharma Ireland Ltd. v. Luye Pharma Group Ltd., 19-1340 (D. Del.) July 17, 2019 Hon. Leonard P. Stark Risperdal Consta® (extended-release risperidone for injection) 6,667,061
Mitsubishi Tanabe Pharma Corp. v. MSN Labs. Private Ltd., 19-15616 (D.N.J.) July 19, 2019 Hon. Peter G. Sheridan Invokamet XR® (canagliflozin / metformin HCl extended-release tablets) 7,943,582
8,513,202
Braintree Labs., Inc. v. Hetero Labs Ltd., 19-15676 (D.N.J.) July 22, 2019 Hon. Michael A. Shipp Suprep® (sodium sulfate / potassium sulfate / magnesium sulfate oral lavage solution) 6,946,149
Corcept Therapeutics, Inc. v. Sun Pharma Global FZE, 19-15678 (D.N.J.) July 22, 2019 Hon. Susan D. Wigenton Korlym® (mifepristone tablets) 8,921,348
10,195,214
9,829,495
AstraZeneca LP v. Dr. Reddy’s Labs., Ltd., 19-15739 (D.N.J.) July 23, 2019 Hon. Claire C. Cecchi Brilinta® (ticagrelor tablets) RE46,276
Bayer Intellectual Property Gmbh v. Sunshine Lake Pharma Co., Ltd., 19-1448 (D. Del.) Aug. 1, 2019 Hon. Timothy Belcher Dyk Xarelto® (rivaroxaban tablets) 9,539,218
Vifor (Int’l) AG v. Sandoz Inc., 19-16305 (D.N.J.) Aug. 2, 2019 Hon. Freda L. Wolfson Injectafer® (ferric carboxymaltose for injection) 7,612,109
7,754,702
8,895,612
9,376,505
Janssen Pharms., Inc. v. Mylan Labs. Ltd., 19-16484 (D.N.J.) Aug. 8, 2019 Hon. Claire C. Cecchi Invega Sustenna® (paliperidone palmitate extended-release injectable suspension) 9,439,906
Abraxis Bioscience, LLC v. Sun Pharma Advanced Research Co., Ltd., 19-16495 (D.N.J.) Aug. 8, 2019 Hon. Stanley R. Chesler Abraxane® (paclitaxel protein-bound particles for injectable suspension) 7,758,891
7,820,788
7,923,536
8,034,375
8,138,229
8,268,348
8,314,156
8,853,260
9,101,543
9,393,318
9,511,046
9,597,409
Janssen Pharms., Inc. v. Mylan Labs. Ltd., 19-1488 (D. Del.) Aug. 9, 2019 Hon. Colm F. Connolly Invega Sustenna® (paliperidone palmitate extended-release injectable suspension) 9,439,906
Par Pharm., Inc. v. American Regent, Inc., 19-1490 (D. Del.) Aug. 9, 2019 Hon. Colm F. Connolly Vasostrict® (vasopressin for injection) 9,375,478
9,687,526
9,744,209
9,750,785
Boehringer Ingelheim Pharms. Inc. v. Aizant Drug Research Solutions Prv. Ltd., 19-1492 (D. Del.) Aug. 9, 2019 Hon. Colm F. Connolly Jardiance® (empagliflozin tablets) 10,258,637
Boehringer Ingelheim Pharms. Inc. v. Alkem Labs. Ltd., 19-1493 (D. Del.) Aug. 9, 2019 Hon. Colm F. Connolly Jardiance® (empagliflozin tablets)    Glyxambi® (empagliflozin / linagliptin tablets) 10,258,637
Boehringer Ingelheim Pharms. Inc. v. Cipla Ltd., 19-1494 (D. Del.) Aug. 9, 2019 Hon. Colm F. Connolly Synjardy® XR (empagliflozin / metformin extended-release tablets) 10,258,637
Boehringer Ingelheim Pharms. Inc. v. Dr. Reddy’s Labs., Ltd., 19-1495 (D. Del.) Aug. 9, 2019 Hon. Colm F. Connolly Jardiance® (empagliflozin tablets) 10,258,637
Boehringer Ingelheim Pharms. Inc. v. Invagen Pharms., Inc., 19-1496 (D. Del.) Aug. 9, 2019 Hon. Colm F. Connolly Jardiance® (empagliflozin tablets) 10,258,637
Boehringer Ingelheim Pharms. Inc. v. Lupin Ltd., 19-1497 (D. Del.) Aug. 9, 2019 Hon. Colm F. Connolly Jardiance® (empagliflozin tablets)    Glyxambi® (empagliflozin / linagliptin tablets) 10,258,637
Boehringer Ingelheim Pharms. Inc. v. Mankind Pharma Ltd., 19-1498 (D. Del.) Aug. 9, 2019 Hon. Colm F. Connolly Jardiance® (empagliflozin tablets) 10,258,637
Boehringer Ingelheim Pharms. Inc. v. Prinston Pharm. Inc., 19-1499 (D. Del.) Aug. 9, 2019 Hon. Colm F. Connolly Glyxambi® (empagliflozin / linagliptin tablets) 10,258,637
Boehringer Ingelheim Pharms. Inc. v. Sun Pharm. Indus. Ltd., 19-1500 (D. Del.) Aug. 9, 2019 Hon. Colm F. Connolly Jardiance® (empagliflozin tablets)    Glyxambi® (empagliflozin / linagliptin tablets) 10,258,637
Boehringer Ingelheim Pharms. Inc. v. Zydus Pharms. (USA) Inc., 19-1501 (D. Del.) Aug. 9, 2019 Hon. Colm F. Connolly Jardiance® (empagliflozin tablets)    Synjardy® (empagliflozin / metformin tablets) 10,258,637
Janssen Pharms., Inc. v. Mylan Labs. Ltd., 19-0153 (N.D.W.V.) Aug. 9, 2019 Hon. Thomas S. Kleeh Invega Sustenna® (paliperidone palmitate extended-release injectable suspension) 9,439,906
Novo Nordisk Inc. v. Mylan Institutional LLC, 19-1551 (D. Del.) Aug. 20, 2019 Hon. Colm F. Connolly Victoza® (liraglutide recombinant solution for injection) 6,268,343
7,762,994
8,114,833
8,579,869
8,846,618
9,265,893
RE41,956
Novo Nordisk Inc. v. Mylan Institutional LLC, 19-0164 (N.D.W.V.) Aug. 22, 2019 Hon. Thomas S. Kleeh Victoza® (liraglutide recombinant solution for injection) 6,268,343
7,762,994
8,114,833
8,579,869
8,846,618
9,265,893
RE41,956
Currax Pharms. LLC v. Zydus Pharms. (USA) Inc., 19-1569 (D. Del.) Aug. 23, 2019 Hon. Richard G. Andrews Silenor® (doxepin HCl tablets) 8,513,299
9,107,898
9,486,437
9,532,971
9,861,607
9,907,780
10,238,620
Assertio Therapeutics Inc. v. Alkem Labs. Ltd., 19-17170 (D.N.J.) Aug. 23, 2019 Hon. Claire C. Cecchi Nucynta® ER (tapentadol HCl extended-release tablets) 8,309,060
Boehringer Ingelheim Pharms. Inc. v. Annora Pharma Private Ltd., 19-1594 (D. Del.) Aug. 28, 2019 Hon. Colm F. Connolly Jardiance® (empagliflozin tablets) 10,258,637
Boehringer Ingelheim Pharms. Inc. v. Laurus Labs Ltd., 19-1596 (D. Del.) Aug. 28, 2019 Hon. Colm F. Connolly Jardiance® (empagliflozin tablets) 10,258,637
Bial – Portela & CA. S.A. v. Torent Pharms. Ltd., 19-1673 (D. Del.) Sept. 6, 2019 Hon. Colm F. Connolly Aptiom® (eslicarbazepine acetate tablets) 9,750,747
Allergan USA, Inc. v. Aurobindo Pharma Ltd., 19-1674 (D. Del.) Sept. 6, 2019 Hon. Richard G. Andrews Viberzi® (eluxadoline tablets) 7,741,356
7,786,158
8,344,011
8,609,709
8,772,325
9,205,076
9,700,542
10,213,415
Amgen Inc. v. The ACME Labs. Ltd., 19-1702 (D. Del.) Sept. 11, 2019 Hon. Mitchell S. Goldberg Sensipar® (cinacalcet HCl tablets) 9,375,405
Allergan USA, Inc. v. Aurobindo Pharma Ltd., 19-1727 (D. Del.) Sept. 13, 2019 Hon. Richard G. Andrews Viberzi® (eluxadoline tablets) 8,691,860
9,115,091
9,364,489
9,675,587
9,789,125
10,188,632
Genzyme Corp. v. Aizant Drug Research Solutions Private Ltd., 19-1734 (D. Del.) Sept. 16, 2019 Hon. Colm F. Connolly Cerdelga® (eliglustat tablets) 6,916,802
7,253,185
7,615,573
Boehringer Ingelheim Pharms. Inc. v. Macleods Pharms. Ltd., 19-1772 (D. Del.) Sept. 20, 2019 Hon. Colm F. Connolly Tradjenta® (linagliptin tablets) 8,673,927
8,853,156
9,173,859
Horizon Medicines LLC v. Ajanta Pharma Ltd., 19-1814 (D. Del.) Sept. 27, 2019 Hon. Richard G. Andrews Vimovo® (naproxen / esomeprazole magnesium delayed-release tablets) 9,345,695
8,852,636
8,858,996
9,161,920
9,198,888
9,707,181
Horizon Medicines LLC v. Ajanta Pharma Ltd., 19-18555 (D.N.J.) Sept. 30, 2019 Hon. Brian R. Martinotti Vimovo® (naproxen / esomeprazole magnesium delayed-release tablets) 9,345,695
8,852,636
8,858,996
9,161,920
9,198,888
9,707,181
Chiesi USA Inc. v. MSN Pharms. Inc., 19-18564 (D.N.J.) Sept. 30, 2019 Hon. Madeline Cox Arleo Kengreal® (cangrelor for injection) 8,680,052
9,295,687
9,427,448
9,439,921
9,700,575
9,925,265
10,039,780
Chiesi USA Inc. v. Gland Pharma Ltd., 19-18565 (D.N.J.) Sept. 30, 2019 Hon. Madeline Cox Arleo Kengreal® (cangrelor for injection) 9,295,687
Salix Pharms., Ltd. v. Sandoz Inc., 19-18566 (D.N.J.) Sept. 30, 2019 Hon. Michael A. Shipp Xifaxan® (rifaximin tablets) 7,045,620
7,612,199
7,902,206
7,906,542
7,915,275
8,158,644
8,158,781
8,193,196
8,309,569
8,518,949
8,741,904
8,835,452
8,853,231
9,271,968

Oren D. Langer

Partner

Assistant Managing Partner, New York Office
Member of Executive Board

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