New ANDA Cases

Summer 2013

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name

Date Filed

Judge

Drug

Patent
No(s).

Purdue Pharma. Products L.P. v. Dr. Reddy’s Labs., Inc., 13-2067 (D.N.J.)

Apr. 2, 2013

Hon. Jose L. Linares

Intermezzo®(zolpidem tartrate sublingual tablet)

7,682,628

8,242,131

8,252,809

Novartis Pharma. Corp. v. Noven Pharma., Inc., 13-0527 (D. Del.)

Apr. 3, 2013

Hon. Richard G. Andrews

Exelon®Patch (rivastigmine transdermal system or extended-release film)

6,316,023

6,335,031

Novartis Pharma. Corp. v. Accord Healthcare Inc., 13-2379 (D.N.J.)

Apr. 12, 2013

Hon. Susan D. Wigenton

Zometa®(zoledronic acid injection)

8,324,189

Braintree Labs., Inc. v. Gator Pharma., Inc., 13-0389 (M.D. Fla.)

Apr. 15, 2013

Hon. Timothy J. Corrigan

Suprep®Bowel Prep Kit (sodium sulfate / potassium sulfate / magnesium sulfate)

6,946,149

Braintree Labs., Inc. v. Gator Pharma., Inc., 13-1975 (E.D. Pa.)

Apr. 15, 2013

Hon. Paul S. Diamond

Suprep®Bowel Prep Kit (sodium sulfate / potassium sulfate / magnesium sulfate)

6,946,149

Shionogi & Co., Ltd. v. Hospira, Inc., 13-2400 (D.N.J.)

Apr. 15, 2013

Hon. Freda L. Wolfson

Doribax®(doripenem for injection)

8,247,402

Helsinn Healthcare S.A. v. Aurobindo Pharma Ltd., 13-0688 (D. Del.)

Apr. 16, 2013

Hon. Sherry R. Fallon

Aloxi®(palonosetron hydrochloride intravenous solution)

7,947,724

7,947,725

7,960,424

Pfizer Inc. v. Inventia Healthcare Private Ltd., 13-2986 (N.D. Ill.)

Apr. 19, 2013

Hon. Edmond E. Chang

Detrol®LA (tolterodine tartrate extended-release capsules)

6,630,162

6,770,295

Par Pharma., Inc. v. Takeda Pharma. Co., Ltd., 13-1927 (N.D. Ca.)

Apr. 26, 2013

Hon. Lucy H. Koh

Dexilant®(dexlansoprazole capsules)

8,105,626

8,173,158

Acura Pharma., Inc. v. Ranbaxy Inc., 13-0750 (D. Del.)

Apr. 29, 2013

Hon. Richard G. Andrews

Oxecta®(oxycodone hydrochloride tablets)

7,510,726

The Medicines Co. v. Apotex Inc., 13-2801 (D.N.J.)

May 1, 2013

Hon. Peter G. Sheridan

Angiomax®(bivalirudin for injection)

7,582,727

7,598,343

AstraZeneca AB v. Watson Labs., Inc.—Florida, 13-13-3038 (D.N.J.)

May 10, 2013

Hon. Joel A. Pisano

Vimovo®(naproxen / esomeprazole magnesium delayed-release tablets)

5,714,504

6,369,085

6,875,872

7,411,070

7,745,466

Purdue Pharma L.P. v. Impax Labs., Inc., 13-3188 (S.D.N.Y.)

May 10, 2013

Hon. Sidney H. Stein

OxyContin®(oxycodone hydrochloride)

8,337,888

Bayer Pharma AG v. Par Pharma., Inc., 13-0845 (D. Del.)

May 14, 2013

Hon. Gregory M. Sleet

Staxyn®(vardenafil hydrochloride orally disintegrating tablets)

6,362,178

7,696,206

Senju Pharma. Co., Ltd. v. Strides, Inc., 13-0851 (D. Del.)

May 15, 2013

Hon. Sue L. Robinson

Zymar®/ Zymaxid®(gatifloxacin ophthalmic solution)

6,333,045

Abbvie, Inc. v. Hetero USA Inc., 13-0852 (D. Del.)

May 15, 2013

Hon. Richard G. Andrews

Norvir®(ritonavir tablets)

7,148,359

7,364,752

8,268,349

6,037,157

6,703,403

Endo Pharma. Inc. v. Par Pharma. Co., Inc., 13-3284 (S.D.N.Y.)

May 15, 2013

Hon. Thomas P. Griesa

Opana®ER CRF (oxymorphone hydrochloride extended-release tablets)

7,851,482

8,309,122

8,329,216

Endo Pharma. Inc. v. Teva Pharma. USA Inc., 13-3285 (S.D.N.Y.)

May 15, 2013

Hon. Thomas P. Griesa

Opana®ER CRF (oxymorphone hydrochloride extended-release tablets)

7,851,482

8,309,122

8,329,216

Endo Pharma. Inc. v. Mallinckrodt, LLC, 13-3286 (S.D.N.Y.)

May 15, 2013

Hon. Thomas P. Griesa

Opana®ER CRF (oxymorphone hydrochloride extended-release tablets)

7,851,482

8,309,122

8,329,216

Endo Pharma. Inc. v. Sandoz, Inc., 13-3287 (S.D.N.Y.)

May 15, 2013

Hon. Thomas P. Griesa

Opana®ER CRF (oxymorphone hydrochloride extended-release tablets)

7,851,482

8,309,122

8,329,216

Endo Pharma. Inc. v. Roxane Labs., Inc., 13-3288 (S.D.N.Y.)

May 15, 2013

Hon. Thomas P. Griesa

Opana®ER CRF (oxymorphone hydrochloride extended-release tablets)

7,851,482

8,309,122

8,329,216

Purdue Pharma L.P. v. Amneal Pharma., LLC, 13-3372 (S.D.N.Y.)

May 17, 2013

Hon. Sidney H. Stein

OxyContin®(oxycodone hydrochloride)

8,337,888

Purdue Pharma L.P. v. Par Pharma., Inc., 13-3374 (S.D.N.Y.)

May 17, 2013

Hon. Sidney H. Stein

OxyContin®(oxycodone hydrochloride)

8,337,888

8,309,060

Fresenius Kabi USA, LLC v. Dr. Reddy’s Labs., Ltd., 13-0925 (D. Del.)

May 23, 2013

Hon. Sue L. Robinson

Diprivan®(propofol 1% injectable emulsion)

5,714,520

5,731,355

5,731,356

5,908,869

Eli Lilly and Co. v. Perrigo Co., 13-0851 (S.D. Ind.)

May 24, 2013

Hon. Sarah Evans Barker

Axiron®(testosterone metered transdermal solution)

8,435,944

8,419,307

8,177,449

Takeda Pharma. Co., Ltd. v. Impax Labs., Inc., 13-2416 (N.D. Cal.)

May 29, 2013

Hon. Elizabeth D. Laporte

Dexilant®(dexlansoprazole delayed-release capsules)

8,173,158

Takeda Pharma. Co., Ltd. v. Sandoz Inc., 13-2418 (N.D. Cal.)

May 29, 2013

Hon. Donna M. Ryu

Dexilant®(dexlansoprazole delayed-release capsules)

8,173,158

Takeda Pharma. Co., Ltd. v. TWI Pharma. Inc., 13-2420 (N.D. Cal.)

May 29, 2013

Hon. Laurel Beeler

Dexilant®(dexlansoprazole delayed-release capsules)

8,173,158

Avanir Pharma. Inc. v. Sandoz, Inc., 13-0961 (D. Del.)

May 30, 2013

Hon. Leonard P. Stark

Nuedexta®(dextromethorphan hydrobromide / quinidine sulfate capsules)

7,659,282

8,227,484

RE38,115

Merck & CIE v. Watson Labs., Inc., 13-0978 (D. Del.)

June 4, 2013

Hon. Richard G. Andrews

Safyral®(drospirenone / ethinyl estradiol / levomefolate calcium tablets and levomefolate calcium tablets)

6,441,168

Pfizer Inc. v. Dr. Reddy’s Labs., Ltd., 13-0989 (D. Del.)

June 4, 2013

Hon. Sue L. Robinson

Pristiq®(O-desmethylvenlafaxine succinate extended-release tablets)

6,673,838

8,269,040

Merck & CIE v. Watson Labs., Inc., 13-0990 (D. Nev.)

June 4, 2013

Hon. Andrew P. Gordon

Safyral®(drospirenone / ethinyl estradiol / levomefolate calcium tablets and levomefolate calcium tablets)

6,441,168

Abbvie, Inc. v. Dr. Reddy’s Labs. Ltd., 13-1012 (D. Del.)

June 5, 2013

Hon. Gregory M. Sleet

Zemplar®(paricalcitol for injection)

6,136,799

6,361,758

5,597,815

Fresenius Kabi USA, LLC v. Watson Labs., Inc., 13-1015 (D. Del.)

June 6, 2013

Hon. Sue L. Robinson

Diprivan®(propofol 1% injectable emulsion)

5,714,520

5,731,355

5,731,356

5,908,869

Sun Pharma Global FZE v. Novartis Pharma. Corp., 13-3542 (D.N.J.)

June 7, 2013

Hon. Dennis M. Cavanaugh

Gleevac®(imatinib mesylate tablets)

6,894,051

Abbvie, Inc. v. Mylan Pharma., Inc., 13-1072 (D. Del.)

June 14, 2013

Hon. Richard G. Andrews

Norvir®(ritonavir soft gelatin capsule)

6,232,333

7,141,593

7,432,294

Insite Vision Inc. v. Mylan Pharma. Inc., 13-3720 (D.N.J.)

June 14, 2013

Hon. Mary L. Cooper

AzaSite®(azithromycin ophthalmic solution)

6,861,411

6,239,113

6,569,443

7,056,893

Senju Pharma. Co., Ltd. v. Apotex Inc., 13-4132 (S.D.N.Y.)

June 14, 2013

Hon. Paul A. Crotty

Istalol®(timolol maleate ophthalmic solution)

6,335,335

Accord Healthcare, Inc. v. Eli Lilly and Co., IPR2013-00356 (PTAB)

June 14, 2013

N/A

Alimta®(pemetrexed for injection)

7,772,209

Kissei Pharma. Co., Ltd. v. Hetero USA Inc., 13-1091 (D. Del.)

June 17, 2013

Hon. Leonard P. Stark

Rapaflo®(silodosin capsules)

5,387,603

Kissei Pharma. Co., Ltd. v. Sandoz Inc., 13-1092 (D. Del.)

June 17, 2013

Hon. Leonard P. Stark

Rapaflo®(silodosin capsules)

5,387,603

Alza Corp. v. Par Pharma., Inc., 13-1104 (D. Del.)

June 19, 2013

Hon. Richard G. Andrews

Concerta®(methylphenidate hydrochloride)

8,163,798

Amneal Pharma., LLC v. Supernus Pharma, LLC, IPR2013-00368 (PTAB)

June 20, 2013

N/A

Oracea®(doxycycline)

8,206,740

Amneal Pharma., LLC v. Supernus Pharma, LLC, IPR2013-00371 (PTAB)

June 20, 2013

N/A

Oracea®(doxycycline)

8,394,405

Amneal Pharma., LLC v. Supernus Pharma, LLC, IPR2013-00372 (PTAB)

June 20, 2013

N/A

Oracea®(doxycycline)

8,394,406

Pfizer Inc. v. Alkem Labs., Ltd., 13-1110 (D. Del.)

June 21, 2013

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

Pfizer Inc. v. Sandoz, Inc., 13-1111 (D. Del.)

June 21, 2013

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

Par Pharma., Inc. v. Breckenridge Pharma., Inc., 13-1114 (D. Del.)

June 21, 2013

Hon. Sue L. Robinson

Megace®ES (megestrol acetate oral suspension)

6,592,903

7,101,576

Endo Pharma. Inc. v. Ranbaxy Labs. Ltd., 13-4343 (S.D.N.Y.)

June 21, 2013

Unassigned

Opana®ER CRF (oxymorphone hydrochloride extended-release tablets)

7,851,482

8,309,122

8,329,216

Pfizer Inc. v. Alkem Labs., Ltd., 13-4628 (N.D. Ill.)

June 24, 2013

Hon. Joan B. Gottschall

Toviaz®(fesoterodine fumarate extended-release tablets)

6,858,650

7,384,980

7,855,230

7,985,772

8,338,478

Janssen Products, L.P. v. Lupin Ltd., 13-3891 (D.N.J.)

June 24, 2013

Hon. William H. Walls

Prezista®(darunavir tablets)

7,700,645

7,126,015

7,595,408

Alza Corp. v. Osmotica Kereskedelmi Es Szolgaltato Kft, 13-1126 (D. Del.)

June 24, 2013

Hon. Richard G. Andrews

Concerta®(methylphenidate hydrochloride)

8,163,798

Alpex Pharma, S.A. v. Zydus Pharma. USA, Inc., 13-1143 (D. Del.)

June 26, 2013

Hon. Sue L. Robinson

Suprenza®(phentermine hydrochloride tablets)

6,149,938

Alza Corp. v. Osmotica Kereskedelmi Es Szolgaltato Kft

June 26, 2013

Hon. Elaine E. Bucklo

Concerta®(methylphenidate hydrochloride)

8,163,798

Par Pharma., Inc. v. Breckenridge Pharma., Inc., 13-4000 (D.N.J.)

June 27, 2013

Hon. Kevin McNulty

Megace®ES (megestrol acetate oral suspension)

6,592,903

7,101,576

Merck, Sharp & Dohme Corp. v. Cipla USA, Inc., 13-4017 (D.N.J.)

June 27, 2013

Hon. Jerome B. Simandle

Sustiva®(efavirenz tablets)

6,639,071

6,939,964

U.S. Dept. of Health and Human Services v. Lupin Ltd., 13-4039 (D.N.J.)

June 27, 2013

Hon. William H. Walls

Prezista®(darunavir tablets)

7,470,506

UCB Inc. v. Zydus Pharma. (USA), Inc., 13-4021 (D.N.J.)

June 28, 2013

Hon. Michael A. Shipp

Vimpat®(lacosamide tablets)

RE38,551

AstraZeneca AB v. Mylan Pharma., 13-4022 (D.N.J.)

June 28, 2013

Hon. Joel A. Pisano

Vimovo®(naproxen / esomeprazole magnesium delayed-release tablets)

5,714,504

6,369,085

6,875,872

7,411,070

7,745,466

5,948,789

UCB Inc. v. Teva Pharma. USA, Inc., 13-1148 (D. Del.)

June 28, 2013

Hon. Leonard P. Stark

Vimpat®(lacosamide tablets)

RE38,551

Pfizer Inc. v. Lupin Ltd., 13-1153 (D. Del.)

June 28, 2013

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

Pfizer Inc. v. Zydus Pharma. (USA), Inc., 13-1154 (D. Del.)

June 28, 2013

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

Pfizer Inc. v. Accord Healthcare Inc., USA, 13-1155 (D. Del.)

June 28, 2013

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

Pfizer Inc. v. Amerigan Pharma., Inc., 13-1156 (D. Del.)

June 28, 2013

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

Pfizer Inc. v. Amneal Pharma., LLC, 13-1157 (D. Del.)

June 28, 2013

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

Pfizer Inc. v. Impax Labs., Inc., 13-1158 (D. Del.)

June 28, 2013

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


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