New ANDA Cases

Fall 2016

GENERICally Speaking
Case Name Date Filed Judge Drug Patent No(s).
Apotex Inc. v. Eli Lilly & Co., IPR2016-01190 (PTAB) July 1, 2016 N/A Alimta® (pemetrexed disodium for injection) 7,772,209
Apotex Inc. v. Eli Lilly & Co., IPR2016-01191 (PTAB) July 1, 2016 N/A Alimta® (pemetrexed disodium for injection) 7,772,209
Teva Pharms. USA, Inc. v. Eli Lilly & Co., IPR2016-01340 (PTAB) July 1, 2016 N/A Alimta® (pemetrexed disodium for injection) 7,772,209
Teva Pharms. USA, Inc. v. Eli Lilly & Co., IPR2016-01341 (PTAB) July 1, 2016 N/A Alimta® (pemetrexed disodium for injection) 7,772,209
Teva Pharms. USA, Inc. v. Eli Lilly & Co., IPR2016-01343 (PTAB) July 1, 2016 N/A Alimta® (pemetrexed disodium for injection) 7,772,209
Orexo AB v. Actavis Elizabeth LLC, 16-0582 (D. Del.) July 7, 2016 Hon. Sue L. Robinson Zubsolv® (buprenorphine hydrochloride / naloxone hydrochloride sublingual tablets) 9,259,421
AstraZeneca AB v. Apotex Corp., 16-0583 (D. Del.) July 7, 2016 Hon. Gregory M. Sleet Onglyza® (saxagliptin hydrochloride tablets) RE44,186
Mallinckrodt Hospital Products IP Ltd. v. Praxair Distribution Inc., 16-0592 (D. Del.) July 8, 2016 Hon. Gregory M. Sleet INOmax® (nitric oxide for inhalation)
9,265,911
9,295,802
9,279,794
Gilead Sciences, Inc. v. Aurobindo Pharma Ltd., 16-4178 (D.N.J.) July 8, 2016 Hon. Renee Marie Bumb Truvada® (emtricitabine / tenofovir disoproxil fumarate tablets)
6,642,245
6,703,396
8,592,397
8,716,264
Mylan Inc. v. Dr. Falk Pharma GmbH, IPR2016-01386 (PTAB) July 8, 2016 N/A Apriso® (mesalamine extended-release capsules) 8,865,688
Teva Pharms. USA, Inc. v. Eli Lilly & Co., IPR2016-01393 (PTAB) July 8, 2016 N/A Alimta® (pemetrexed disodium for injection) 7,772,209
Imprimis Pharms., Inc. v. Alcon Pharms. Ltd., 16-1794 (S.D. Cal.) July 11, 2016 Hon. Marilyn L. Huff
Vigamox® (moxifloxacin hydrochloride ophthalmic solution)
 
Moxeza® (moxifloxacin hydrochloride ophthalmic solution)
6,716,830
7,671,070
Fohill Capital Partners v. Dr. Falk Pharma GmbH, IPR2016-01409 (PTAB) July 11, 2016 N/A Apriso® (mesalamine extended-release capsules) 8,865,688
Tris Pharma, Inc. v. Actavis Elizabeth LLC, 16-0603 (D. Del.) July 12, 2016 Hon. Gregory M. Sleet QuilliChew ER® (methylphenidate hydrochloride extended-release chewable tablets)
8,202,537
8,287,903
8,999,386
9,295,642
Helsinn Healthcare S.A. v. Zydus Pharms. (USA) Inc., 16-4239 (D.N.J.) July 12, 2016 Hon. Mary L. Cooper Aloxi® (palonosetron hydrochloride injection)
7,947,724
7,947,725
7,960,424
8,598,219
8,729,094
Amneal Pharms. LLC v. Yeda Research & Development Co. Ltd., PGR2016-00028 (PTAB) July 12, 2016 N/A Copaxone® (glatiramer acetate injection) 9,155,776
Actavis Elizabeth LLC v. Novartis Pharms. Corp., 16-0604 (D. Del.) July 13, 2016 Hon. Richard G. Andrews Jadenu® (deferasirox tablets) 9,283,209
Shionogi Inc. v. Actavis Labs. UT, Inc., 16-0606 (D. Del.) July 14, 2016 Hon. Leonard P. Stark Ulesfia® (benzyl alcohol lotion)
6,793,931
7,294,342
Apotex Inc. v. Eli Lilly & Co., IPR2016-01429 (PTAB) July 14, 2016 N/A Alimta® (pemetrexed disodium for injection) 7,772,209
Valeant Pharms. Luxembourg S.A.R.L. v. Actavis Labs. UT, Inc., 16-4344 (D.N.J.) July 15, 2016 Hon. Jose L. Linares Carac® (fluorouracil topical cream) 6,670,335
Amneal Pharms. LLC v. Purdue Pharma L.P., IPR2016-01412 (PTAB) July 15, 2016 N/A OxyContin® (oxycodone hydrochloride extended-release tablets) 9,034,376
Amneal Pharms. LLC v. Purdue Pharma L.P., IPR2016-01413 (PTAB) July 15, 2016 N/A OxyContin® (oxycodone hydrochloride extended-release tablets) 9,034,376
Roxane Labs., Inc. v. Novartis AG, IPR2016-01461 (PTAB) July 19, 2016 N/A Afinitor® (everolimus tablets) 9,006,224
Allergan, Inc. v. TWi Pharms., Inc., 16-0620 (D. Del.) July 20, 2016 Hon. Gregory M. Sleet Restasis® (cyclosporine ophthalmic emulsion)
8,629,111
8,633,162
8,642,556
8,648,048
8,685,930
9,248,191
AstraZeneca AB v. Aurobindo Pharma Ltd., 16-4414 (D.N.J.) July 20, 2016 Hon. Mary L. Cooper Nexium® 24HR (esomeprazole magnesium delayed-release capsules)
6,369,085
7,411,070
Koios Pharms. LLC v. Medac Gesellschaft für klinische Spezialpräparate mbH, IPR2016-01370 (PTAB) July 20, 2016 N/A Rasuvo® (methotrexate solution) 8,664,231
Horizon Therapeutics, Inc. v. Lupin Ltd., 16-4438 (D.N.J.) July 21, 2016 Hon. Robert B. Kugler Ravicti® (glycerol phenylbutyrate oral solution)
9,254,278
9,326,966
Allergan, Inc. v. TWi Pharms., Inc., 16-0820 (E.D. Tex.) July 21, 2016 Hon. William C. Bryson Restasis® (cyclosporine ophthalmic emulsion)
8,629,111
8,633,162
8,642,556
8,648,048
8,685,930
9,248,191
Par Pharm., Inc. v. Novartis AG, IPR2016-01479 (PTAB) July 22, 2016 N/A Afinitor® (everolimus tablets) 9,006,224
Bayer Intellectual Property GmbH v. Breckenridge Pharm., Inc., 16-0628 (D. Del.) July 25, 2016 Hon. Sue L. Robinson Xarelto® (rivaroxaban tablets)
7,157,456
7,592,339
Fustibal LLC v. Bayer HealthCare, LLC, IPR2016-01490 (PTAB) July 25, 2016 N/A Stivarga® (regorafenib tablets) 8,637,553
Vivus, Inc. v. Hetero USA, Inc., 16-4560 (D.N.J.) July 27, 2016 Hon. Katharine S. Hayden Stendra® (avanafil tablets)
6,656,935
7,501,409
Sumitomo Dainippon Pharma Co., Ltd. v. Amneal Pharms. LLC, 16-4596 (D.N.J.) July 29, 2016 Hon. Stanley R. Chesler Latuda® (lurasidone hydrochloride tablets) 5,532,372
Novartis Pharms. Corp. v. Teva Pharms. USA, Inc., 16-0648 (D. Del.) July 29, 2016 Hon. Richard G. Andrews Jadenu® (deferasirox tablets) 6,465,504
AstraZeneca Pharms. LP v. Mylan Institutional LLC, 16-4612 (D.N.J.) July 29, 2016 Hon. Renee Marie Bumb Faslodex® (fulvestrant for injection)
6,774,122
7,456,160
8,329,680
8,466,139
Galderma Labs., L.P. v. Taro Pharms. U.S.A., Inc., 16-2207 (N.D. Tex.) July 29, 2016 Hon. Ed Kinkeade Epiduo® Forte (adapalene / benzoyl peroxide gel)
8,445,543
8,785,420
8,809,305
AstraZeneca Pharms. LP v. Mylan Institutional LLC, 16-0669 (D. Del.) Aug. 5, 2016 Hon. Richard G. Andrews Faslodex® (fulvestrant for injection)
6,774,122
7,456,160
8,329,680
8,466,139
Shionogi Inc. v. Hi-Tech Pharmacal Co., Inc., 16-0676 (D. Del.) Aug. 8, 2016 Hon. Leonard P. Stark Ulesfia® (benzyl alcohol lotion)
6,793,931
7,294,342
Mylan Pharms. Inc. v. Boehringer Ingelheim International GMBH, IPR2016-01563 (PTAB) Aug. 10, 2016 N/A
Tradjenta® (linagliptin tablets)
 
Jentadueto® (linagliptin / metformin hydrochloride tablets)
8,673,927
Mylan Pharms. Inc. v. Boehringer Ingelheim International GMBH, IPR2016-01564 (PTAB) Aug. 10, 2016 N/A
Tradjenta® (linagliptin tablets)
 
Jentadueto® (linagliptin / metformin hydrochloride tablets)
8,846,695
Mylan Pharms. Inc. v. Boehringer Ingelheim International GMBH, IPR2016-01565 (PTAB) Aug. 10, 2016 N/A
Tradjenta® (linagliptin tablets)
 
Jentadueto® (linagliptin / metformin hydrochloride tablets)
8,853,156
Mylan Pharms. Inc. v. Boehringer Ingelheim International GMBH, IPR2016-01566 (PTAB) Aug. 10, 2016 N/A
Tradjenta® (linagliptin tablets)
 
Jentadueto® (linagliptin / metformin hydrochloride tablets)
9,173,859
Amneal Pharms. LLC v. Hospira, Inc., IPR2016-01577 (PTAB) Aug. 10, 2016 N/A Precedex® (dexmedetomidine hydrochloride for injection) 8,242,158
Amneal Pharms. LLC v. Hospira, Inc., IPR2016-01578 (PTAB) Aug. 10, 2016 N/A Precedex® (dexmedetomidine hydrochloride for injection) 8,338,470
Amneal Pharms. LLC v. Hospira, Inc., IPR2016-01579 (PTAB) Aug. 10, 2016 N/A Precedex® (dexmedetomidine hydrochloride for injection) 8,455,527
Amneal Pharms. LLC v. Hospira, Inc., IPR2016-01580 (PTAB) Aug. 10, 2016 N/A Precedex® (dexmedetomidine hydrochloride for injection) 8,648,106
Wockhardt Bio AG v. Janssen Oncology, Inc., IPR2016-01582 (PTAB) Aug. 10, 2016 N/A Zytiga® (abiraterone acetate tablets) 8,822,438
Lupin Atlantis Holdings, S.A. v. InvaGen Pharms., Inc., 16-0708 (D. Del.) Aug. 11, 2016 Hon. Sue L. Robinson Antara® (fenofibrate capsules)
8,026,281
9,314,447
Horizon Pharma, Inc. v. Actavis Labs. FL., Inc., 16-4916 (D.N.J.) Aug. 11, 2016 Hon. Mary L. Cooper Vimovo® (naproxen / esomeprazole magnesium delayed-release tablets)
8,945,621
9,220,698
9,345,695
Horizon Pharma, Inc. v. Dr. Reddy’s Labs. Inc., 16-4918 (D.N.J.) Aug. 11, 2016 Hon. Mary L. Cooper Vimovo® (naproxen / esomeprazole magnesium delayed-release tablets)
8,945,621
9,220,698
9,345,695
Horizon Pharma, Inc. v. Lupin Ltd., 16-4920 (D.N.J.) Aug. 11, 2016 Hon. Mary L. Cooper Vimovo® (naproxen / esomeprazole magnesium delayed-release tablets)
8,945,621
9,220,698
9,345,695
Horizon Pharma, Inc. v. Mylan Pharms. Inc., 16-4921 (D.N.J.) Aug. 11, 2016 Hon. Mary L. Cooper Vimovo® (naproxen / esomeprazole magnesium delayed-release tablets)
8,945,621
9,220,698
9,345,695
Gilead Sciences, Inc. v. Hetero Drugs Ltd., 16-4938 (D.N.J.) Aug. 11, 2016 Hon. Renee Marie Bumb Truvada® (emtricitabine / tenofovir disoproxil fumarate tablets)
6,642,245
6,703,396
8,592,397
8,716,264
Jazz Pharms., Inc. v. Roxane Labs., Inc., 16-4971 (D.N.J.) Aug. 12, 2016 Hon. Esther Salas Xyrem® (sodium oxybate oral solution) 8,731,963
Lupin Atlantis Holdings, S.A. v. InvaGen Pharms., Inc., 16-4535 (E.D.N.Y.) Aug. 12, 2016 Hon. Brian M. Cogan Antara® (fenofibrate capsules)
8,026,281
9,314,447
Horizon Pharma Ireland Ltd. v. Actavis Labs. UT, Inc., 16-5051 (D.N.J.) Aug. 18, 2016 Hon. Noel L. Hillman Pennsaid® (diclofenac sodium topical solution)
9,339,551
9,339,552
9,375,412
9,370,501
Horizon Pharma Ireland Ltd. v. Lupin Ltd., 16-5054 (D.N.J.) Aug. 18. 2016 Hon. Noel L. Hillman Pennsaid® (diclofenac sodium topical solution)
9,339,551
9,339,552
9,375,412
9,370,501
Aurobindo Pharma Ltd. v. AstraZeneca AB, 16-5079 (D.N.J.) Aug. 18, 2016 Hon. Mary L. Cooper Prilosec OTC® (omeprazole magnesium delayed release tablets)
6,403,616
6,428,810
Torrent Pharms. Ltd. v. UCB Pharma GMBH, IPR2016-01636 (PTAB) Aug. 18, 2016 N/A Toviaz® (fesoterodine fumarate extended-release tablets) 6,858,650
Apotex Inc. v. Alcon Research, Ltd., IPR2016-01640 (PTAB) Aug. 18, 2016 N/A Pazeo® (olopatadine hydrochloride ophthalmic solution) 8,791,154
Galderma Labs., L.P. v. Perrigo UK Finco L.P., 16-0732 (D. Del.) Aug. 19, 2016 Hon. Leonard P. Stark Mirvaso® Gel (brimonidine topical gel)
7,439,241
8,426,410
8,859,551
8,410,102
8,513,247
8,513,249
Reckitt Benckiser LLC v. Sun Pharm. Indus., Ltd., 16-5133 (D.N.J.) Aug. 22, 2016 Hon. Renee Marie Bumb Mucinex® (guaifenesin extended-release tablets)
6,372,252
6,955,821
7,838,032
Alembic Pharms. Ltd. v. UCB Pharma GMBH, IPR2016-01596 (PTAB) Aug. 22, 2016 N/A Toviaz® (fesoterodine fumarate extended-release tablets) 6,858,650
Amerigen Pharms. Ltd. v. UCB Pharma GMBH, IPR2016-01665 (PTAB) Aug. 22, 2016 N/A Toviaz® (fesoterodine fumarate extended-release tablets) 6,858,650
Shire Development LLC v. Alkem Labs. Ltd., 16-0747 (D. Del.) Aug. 24, 2016 Hon. Leonard P. Stark Fosrenol® (lanthanum carbonate oral powder)
5,968,976
7,465,465
8,980,327
9,023,397
Otsuka Pharm. Co., Ltd. v. Ajanta Pharma Ltd., 16-5288 (D.N.J.) Aug. 29, 2016 Hon. Jerome B. Simandle Abilify® (aripiprazole tablets) 9,359,302
Galdrema Labs., L.P. v. Seegpharm S.A., 16-2497 (N.D. Tex.) Aug. 29, 2016 Hon. David C. Godbey MetroGel® (metronidazole topical gel)
6,881,726
7,348,317
Neos Therapeutics, Inc. v. Actavis Labs. FL, Inc., 16-0766 (D. Del.) Sept. 1, 2016 Hon. Gregory M. Sleet Adzenys XR-ODT™ (amphetamine extended-release orally disintegrating tablets)
8,709,491
8,840,924
9,017,731
9,265,737
Otsuka Pharm. Co., Ltd. v. Macleods Pharms. Ltd., 16-5400 (D.N.J.) Sept. 2, 2016 Hon. Jerome B. Simandle Abilify® (aripiprazole tablets) 9,359,302
Eli Lilly and Co. v. Sun Pharma Indus. Ltd., 16-0518 (E.D. Va.) Sept. 2, 2016 Hon. Raymond A. Jackson Cialis® (tadalafil tablets) 6,943,166
Eli Lilly and Co. v. Teva Pharms. (USA) Inc., 16-0519 (E.D. Va.) Sept. 2, 2016 Hon. Raymond A. Jackson Cialis® (tadalafil tablets) 6,943,166
Eli Lilly and Co. v. Zydus Pharms. (USA), Ltd., 16-0520 (E.D. Va.) Sept. 2, 2016 Hon. Raymond A. Jackson Cialis® (tadalafil tablets) 6,943,166
Eli Lilly and Co. v. Actavis Labs. UT, Inc., 16-1119 (E.D. Va.) Sept. 2, 2016 Hon. Anthony J. Trenga Cialis® (tadalafil tablets) 6,943,166
Eli Lilly and Co. v. Alembic Pharms. Ltd., 16-1120 (E.D. Va.) Sept. 2, 2016 Hon. Anthony J. Trenga Cialis® (tadalafil tablets) 6,943,166
Eli Lilly and Co. v. Aurobindo Pharma Ltd., 16-1121 (E.D. Va.) Sept. 2, 2016 Hon. Anthony J. Trenga Cialis® (tadalafil tablets) 6,943,166
Eli Lilly and Co. v. Mylan Pharms. Inc., 16-1122 (E.D. Va.) Sept. 2, 2016 Hon. Anthony J. Trenga Cialis® (tadalafil tablets) 6,943,166
West-Ward Pharms. Corp. v. Par Pharm. Inc., 16-5456 (D.N.J.) Sept. 8, 2016 Hon. Brian R. Martinotti Mitigare® (colchicine capsules) 8,927,607
Meda Pharms. Inc. v. Perrigo UK Finco Ltd. Partnership, 16-0794 (D. Del.) Sept. 9, 2016 Hon. Leonard P. Stark Dymista® (azelastine hydrochloride / fluticasone propionate nasal spray)
8,168,620
9,259,428
Unimed Pharms., LLC v. TWi Pharms., Inc., 16-0810 (D. Del.) Sept. 16, 2016 Hon. Richard G. Andrews AndroGel® (testosterone gel)
6,503,894
8,729,057
8,741,881
8,754,070
8,759,329
9,125,816
9,132,089
Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., 16-0812 (D. Del.) Sept. 16, 2016 Hon. Richard G. Andrews Lantus® / Lantus® SoloSTAR® (insulan glargine for injection)
7,918,833
8,512,297
8,556,864
8,603,044
8,992,486
8,679,069
9,011,391
9,233,211
7,476,652
7,713,930
Sanofi-Aventis U.S. LLC v. Sandoz Inc., 16-5678 (D.N.J.) Sept. 16, 2016 Hon. Michael A. Shipp Jevtana® Kit (cabazitaxel for injection)
5,847,170
8,927,592
Otsuka Pharm. Co., Ltd. v. Orchid Pharma Ltd., 16-5688 (D.N.J.) Sept. 16, 2016 Hon. Jerome B. Simandle Abilify® (aripiprazole tablets) 9,359,302
Otsuka Pharm. Co., Ltd. v. Intas Pharms. Ltd., 16-5743 (D.N.J.) Sept. 19, 2016 Hon. Jerome B. Simandle Abilify® (aripiprazole tablets)
9,359,302
9,387,182
Genzyme Corp. v. Mylan Labs. Ltd., 16-5828 (D.N.J.) Sept. 19, 2016 Hon. Stanley R. Chesler Clolar® (clofarabine for injection) 5,661,136
Amgen Inc. v. Aurobindo Pharma Ltd., 16-0853 (D. Del.) Sept. 22, 2016 Hon. Gregory M. Sleet Sensipar® (cinacalcet hydrochloride tablets) 9,375,405
Amgen Inc. v. Micro Labs Ltd., 16-0854 (D. Del.) Sept. 22, 2016 Hon. Gregory M. Sleet Sensipar® (cinacalcet hydrochloride tablets) 9,375,405
Amgen Inc. v. Watson Labs., Inc., 16-0855 (D. Del.) Sept. 22, 2016 Hon. Gregory M. Sleet Sensipar® (cinacalcet hydrochloride tablets) 9,375,405
Eli Lilly and Co. v. Cipla Ltd., 16-1208 (E.D. Va.) Sept. 22, 2016 Hon. Anthony J. Trenga Cialis® (tadalafil tablets) 6,943,166
Impax Labs., Inc. v. Par Pharm., Inc., 16-0856 (D. Del.) Sept. 23, 2016 Hon. Richard G. Andrews Zomig® (zolmitriptan nasal spray) 7,220,767
Otsuka Pharm. Co., Ltd. v. Macleods Pharms. Ltd., 16-5949 (D.N.J.) Sept. 23, 2016 Hon. Jerome B. Simandle Abilify® (aripiprazole tablets) 9,387,182
Genzyme Corp. v. Mylan Labs. Ltd., 16-0188 (N.D.W.V.) Sept. 23, 2016 Hon. Irene M. Keeley Clolar® (clofarabine for injection) 5,661,136
Otsuka Pharm. Co., Ltd. v. Alkem Labs. Ltd., 16-6067 (D.N.J.) Sept. 26, 2016 Hon. Jerome B. Simandle Abilify® (aripiprazole tablets) 9,359,302
Silvergate Pharms., Inc. v. Bionpharma, Inc., 16-0876 (D. Del.) Sept. 28, 2016 Hon. Sue L. Robinson Epaned® (enalapril maleate for oral solution) 8,568,747
Hospira, Inc. v. Par Sterile Products, LLC, 16-0879 (D. Del.) Sept. 29, 2016 Hon. Richard G. Andrews Precedex® (dexmedetomidine hydrochloride for injection)
8,242,158
8,338,470
8,455,527
8,648,106
Amgen Inc. v. Cipla Ltd., 16-0880 (D. Del.) Sept. 29, 2016 Hon. Gregory M. Sleet Sensipar® (cinacalcet hydrochloride tablets) 9,375,405
Amgen Inc. v. Strides Pharma Global PTE Ltd., 16-0881 (D. Del.) Sept. 29, 2016 Hon. Gregory M. Sleet Sensipar® (cinacalcet hydrochloride tablets) 9,375,405
Amgen Inc. v. Sun Pharm. Indus., Ltd., 16-0882 (D. Del.) Sept. 29, 2016 Hon. Gregory M. Sleet Sensipar® (cinacalcet hydrochloride tablets) 9,375,405
Adare Pharms., Inc. v. Apotex, Inc., 16-0884 (D. Del.) Sept. 29, 2016 Hon. Sue L. Robinson Amrix® (cyclobenzaprine hydrochloride extended-release capsules) 9,399,025
Pfizer Inc. v. Aurobindo Pharma Ltd., 16-0886 (D. Del.) Sept. 30, 2016 Hon. Gregory M. Sleet Toviaz® (fesoterodine fumarate extended-release tablets)
6,858,650
7,384,980
7,855,230
7,985,772
8,338,478
Arena Pharms., Inc. v. Lupin Ltd., 16-0887 (D. Del.) Sept. 30, 2016 Hon. Richard G. Andrews Belviq® (lorcaserin hydrochloride tablets)
6,953,787
7,514,422
7,977,329
8,207,158
8,273,734
8,546,379
8,575,149
8,999,970
9,169,213
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