New ANDA Cases

Spring 2013

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
Case Name Date Filed Judge Drug Patent No(s).
Novartis Pharma. Corp. v. Alvogen Pine Brook, Inc., 13-0052 (D. Del.) Jan. 4, 2013 Hon. Richard G. Andrews Exelon® Patch (rivastigmine transdermal system or extended-release film) 6,316,023; 6,335,031
AstraZeneca AB v. Dr. Reddy’s Labs., Inc., 13-0091 (D.N.J.) Jan. 4, 2013 Hon. Joel A. Pisano Vimovo® (naproxen / esomeprazole magnesium delayed-release tablets) 6,926,907; 5,714,504; 7,745,466; 7,411,070; 6,369,085
Allergan, Inc. v. Apotex Inc., 13-0016 (M.D.N.C.) Jan. 8, 2013 Hon. Catherine C. Eagles Latisse® (bimatoprost topical solution, 0.03%) 8,263,054
Cadence Pharma., Inc. v. Fresenius Kabi USA, LLC, 13-0139 (S.D. Ca.) Jan. 17, 2013 Hon. Dana M. Sabraw Ofirmev® (acetaminophen for injection) 6,028,222; 6,992,218
Horizon Pharma, Inc. v. Par Pharma. Cos., Inc., 13-0102 (D. Del.) Jan. 17, 2013 Hon. Leonard P. Stark Duexis® (famotidine / ibuprofen tablets) 8,309,127; 8,318,202
Cadence Pharma., Inc. v. Fresenius Kabi USA, LLC, 13-0453 (N.D. Ill.) Jan. 18, 2013 Hon. Gary Feinerman Ofirmev® (acetaminophen for injection) 6,028,222; 6,992,218
Jazz Pharma., Inc. v. Amneal Pharma., LLC, 13-0391 (N.J.D) Jan. 18, 2013 Hon. Esther Salas Xyrem® (sodium oxybate oral solution) 6,472,431; 6,780,889; 7,262,219; 7,851,506; 7,895,059; 8,263,650; 8,324,275
Endo Pharma. Inc. v. Impax Labs., Inc., 13-0435 (S.D.N.Y.) Jan. 18, 2013 Hon. Thomas P. Griesa Opana® ER (oxymorphone hydrochloride extended-release tablets) 7,851,482; 8,114,383; 8,192,722; 8,309,122; 8,309,060; 8,329,216
Endo Pharma. Inc. v. Actavis, Inc., 13-0436 (S.D.N.Y.) Jan. 18, 2013 Hon. Thomas P. Griesa Opana® ER (oxymorphone hydrochloride extended-release tablets) 7,851,482; 8,114,383; 8,192,722; 8,309,122; 8,309,060; 8,329,216
Hoffman-La Roche Inc. v. Aurobindo Pharma Ltd., 13-0124 (D. Del.) Jan. 22, 2013 Hon Leonard P. Stark Boniva® Once-Monthly (ibandronate sodium tablets) 7,718,634; 7,410,957; 6,294,196
Glenmark Generics Ltd. v. GlaxoSmithKline, PLC, 13-0135 (D. Del.) Jan. 24, 2013 Hon. Christopher J. Burke Bactroban® (mupirocin calcium cream) 6,025,389; 5,569,672
AbbVie, Inc. v. Sun Pharma. Indus. Ltd., 13-0138 (D. Del.) Jan. 24, 2013 Hon. Gregory M. Sleet Zemplar® (paricalcitol capsules) 5,597,815
Pfizer Inc. v. Wockhardt Ltd., 13-0143 (D. Del.) Jan. 25, 2013 Hon. Gregory M. Sleet Lyrica® (pregabalin oral solution) 6,197,819
Santarus, Inc. v. Mylan Inc., 13-0145 (D. Del.) Jan. 28, 2013 Hon. Richard G. Andrews Fenoglide® (fenofibrate orally disintegrating tablets) 7,658,944; 8,124,125
Auxilium Pharma., Inc. v. Upsher-Smith Labs., Inc., 13-0148 (D. Del.) Jan. 28, 2013 Hon. Sue L. Robinson Testim® (testosterone transdermal gel) 7,320,968; 7,608,605; 7,608,606; 7,608,607; 7,608,608; 7,608,609; 7,608,610; 7,935,690; 8,063,029; 8,178,518
Depomed, Inc. v. Purdue Pharma L.P., 13-0571 (D.N.J.) Jan. 29, 2013 Hon. Joel A. Pisano OcyContin® (oxycodone hydrochloride controlled-release tablets) 6,340,475; 6,635,280; 6,723,340
Santarus, Inc. v. Mylan Pharma., Inc., 13-0017 (N.D.W.V.) Jan. 30, 2013 Hon. Irene M. Keeley Fenoglide® (fenofibrate orally disintegrating tablets) 7,658,944; 8,124,125
Purdue Pharma L.P. v. Epic Pharma, LLC, 13-0683 (S.D.N.Y.) Jan. 30, 2013 Hon. Sidney H. Stein OcyContin® (oxycodone hydrochloride extended-release tablets) 7,674,799; 7,674,800; 7,683,072
Purdue Pharma L.P. v. Impax Labs., Inc., 13-0684 (S.D.N.Y.) Jan. 30, 2013 Hon. Sidney H. Stein OcyContin® (oxycodone hydrochloride extended-release tablets) 7,674,799; 7,674,800; 7,683,072
Merck Sharp & Dohme Corp. v. APP Pharma., Inc., 13-0166 (D. Del.) Jan. 31, 2013 Hon. Richard G. Andrews Integrilin® (eptifibatide injection) 5,807,825; 5,747,447; 5,968,902
Purdue Pharma L.P. v. Watson Labs., Inc.—Florida, 13-0762 (S.D.N.Y.) Feb. 1, 2013 Hon. Sidney H. Stein OcyContin® (oxycodone hydrochloride extended-release tablets) 8,309,060
Purdue Pharma L.P. v. Impax Labs., Inc., 13-0763 (S.D.N.Y.) Feb. 1, 2013 Hon. Sidney H. Stein OcyContin® (oxycodone hydrochloride extended-release tablets) 8,114,383; 8,309,060
Cadence Pharma., Inc. v. Sandoz Inc., 13-0278 (S.D. Ca.) Feb. 4, 2013 Hon. John A. Houston Ofirmev® (acetaminophen for injection) 6,028,222; 6,992,218
Cadence Pharma., Inc. v. Sandoz Inc., 13-0733 (D.N.J.) Feb. 5, 2013 Hon. Freda L. Wolfson Ofirmev® (acetaminophen for injection) 6,028,222; 6,992,218
Sucampo AG v. Anchen Pharma., Inc., 13-0202 (D. Del.) Feb. 7, 2013 Hon. Gregory M. Sleet Amitiza® (lubiprostone capsules) 6,414,016; 7,795,312; 8,026,393; 8,071,613; 8,097,653; 8,338,639
Unimed Pharma., LLC v. Perrigo Co., 13-0236 (D. Del.) Feb. 15, 2013 Hon. Leonard P. Stark AndroGel® (testosterone gel) 6,503,894
Novartis Pharma. Corp. v. Actavis LLC, 13-1028 (D.N.J.) Feb. 20, 2013 Hon. Susan D. Wigenton Zometa® (zoledronic acid for injection); Reclast® (zoledronic acid for injection) 7,932,241; 8,052,987; 8,324,189
Purdue Pharma L.P. v. Watson Labs., Inc.—Florida, 13-1272 (S.D.N.Y.) Feb. 25, 2013 Hon. Sidney H. Stein OcyContin® (oxycodone hydrochloride extended-release tablets) 8,337,888
Depomed, Inc. v. Watson Labs., Inc.—Florida, 13-0342 (D. Del.) Feb. 28, 2013 Hon. Sue L. Robinson Glumetza® (metformin hydrochloride extended-release tablets) 6,488,962; 6,723,340; 6,635,280; 6,340,475
Eli Lilly and Co. v. Accord Healthcare, Inc., USA, 13-0335 (S.D. Ind.) Feb. 28, 2013 Hon. William T. Lawrence Alimta® (pemetrexed disodium for injection) 7,772,209
Endo Pharma. Inc. v. Watson Pharma., Inc., 13-0192 (E.D. Tex.) Feb. 28, 2013 Hon. J. Rodney Gilstrap Fortesta® (testosterone gel) 6,319,913; 6,579,865
AbbVie Inc. v. The Kennedy Trust for Rheumatology Research, 13-1358 (S.D.N.Y.) Feb. 28, 2013 Hon. Paul A. Crotty Humira® (adalimumab) 8,298,537; 8,383,120
G.D. Searle LLC v. Lupin Pharma., Inc., 13-0121 (E.D. Va.) Mar. 5, 2013 Hon. Arenda L. Wright Allen Celebrex® (celecoxib capsules) RE44,048
Novartis Pharma. Corp. v. Alvogen Pine Brook, Inc., 13-0370 (D. Del.) Mar. 7, 2013 Hon. Richard G. Andrews Exelon® Patch (rivastigmine transdermal system or extended-release film) 6,316,023; 6,335,031
Novartis Pharma. Corp. v. Actavis, Inc., 13-0371 (D. Del.) Mar. 7, 2013 Hon. Richard G. Andrews Exelon® Patch (rivastigmine transdermal system or extended-release film) 6,316,023; 6,335,031
Merck, Sharp & Dohme Corp. v. Hetero USA Inc., 13-1402 (D.N.J.) Mar. 7, 2013 Hon. Jerome B. Simandle Sustiva® (efavirenz tablets) 6,639,071; 6,939,964; 6,673,372
Janssen Products, L.P. v. Hetero Drugs, Ltd., 13-1444 (D.N.J.) Mar. 8, 2013 Hon. William H. Walls Prezista® (darunavir) 7,126,015; 7,595,408
Intendis Gmbh v. Glenmark Generics Ltd., 13-0421 (D. Del.) Mar. 14, 2013 Hon. Sue L. Robinson Finacea® (azelaic acid gel) 6,534,070
Apotex, Inc. v. Teva Pharma. Indus., Ltd., 13-60601 (S.D. Fl.) Mar. 14, 2013 Hon. Donald M. Middlebrooks Accupril® (quinapril hydrochloride) 6,531,486
Boehringer Ingelheim Pharma Gmbh & Co. KG v. Kremers Urban Pharma. Inc., 13-1580 (D.N.J.) Mar. 14, 2013 Hon. Noel L. Hillman Aggrenox® (dipyridamole / aspirin extended-release capsules) 6,015,577
Pharmacia & Upjohn Co. LLC v. Apotex Inc., 13-2034 (N.D. Ill.) Mar. 15, 2013 Hon. Matthew F. Kennelly Zyvox® (linezolid tablets) 5,688,792
AstraZeneca AB v. Watson Labs., Inc.—Florida, 13-1669 (D.N.J.) Mar. 19, 2013 Hon. Joel A. Pisano Nexium® (esomeprazole magnesium delayed-release capsules) 5,714,504; 5,877,192; 6,369,085; 6,875,872; 7,411,070
Pfizer Inc. v. Lupin Ltd., 13-1778 (D.N.J.) Mar. 21, 2013 Hon. Dennis M. Cavanaugh Detrol® LA (tolterodine tartrate extended-release capsules) 6,630,162; 6,770,295
Millenium Pharma., Inc. v. Fresenius KABI USA, LLC, 13-0467 (D. Del.) Mar. 22, 2013 Hon. Gregory M. Sleet Velcade® (bortezomib) 6,713,446; 6,958,319
Takeda Pharma. U.S.A., Inc. v. Amneal Pharma., LLC, 13-0493 (D. Del.) Mar. 28, 2013 Hon. Sue L. Robinson Colcrys® (colchicine) 7,619,004; 7,601,758; 7,820,681; 7,915,269; 7,964,647; 7,964,648; 7,981,938; 8,093,296; 8,093,297; 8,097,655
Mallinckrodt LLC v. Taro Pharma. Indus. Ltd., 13-0494 (D. Del.) Mar. 28, 2013 Hon. Richard G. Andrews Pennsaid® (diclofenac sodium topical solution) 8,217,078
Unimed Pharma., LLC v. Watson Labs., Inc., 13-0496 (D. Del.) Mar. 29, 2013 Hon. Leonard P. Stark AndroGel® (testosterone gel) 6,503,894