New ANDA Cases

Summer 2012

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name

Date Filed

Judge

Drug

Patent No(s).

Teva Pharma. USA Inc. v. Synthon Pharma., Inc., 12-2556 (S.D.N.Y.)

Apr. 3, 2012

Hon. Barbara S. Jones

Copaxone®(glatiramer acetate injection)

7,199,098

6,939,539

6,054,430

6,620,847

5,981,589

6,342,476

6,362,161

AR Holding Co., Inc. v. Par Pharma., Inc., 12-0419 (D. Del.)

Apr. 4, 2012

Hon. Mary Pat Thynge

Colcrys®(colchicine USP)

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

Teva Pharma. USA, Inc. v. Synthon Pharma., Inc., 12-0179 (E.D.N.C.)

Apr. 4, 2012

Hon. James C. Dever, III

Copaxone®(glatiramer acetate injection)

7,199,098

6,939,539

6,054,430

6,620,847

5,981,589

6,342,476

6,362,161

Allergan Sales, LLC v. Akorn, Inc., 12-0175 (E.D. Tex.)

Apr. 4, 2012

Hon. Rodney Gilstrap

Acular LS®(ketorolac tromethamine ophthalmic solution, 0.4%)

8,008,338

Allergan Sales, LLC v. Alcon Research, Ltd., 12-0177 (E.D. Tex.)

Apr. 4, 2012

Hon. Rodney Gilstrap

Acular LS®(ketorolac tromethamine ophthalmic solution, 0.4%)

8,008,338

Allergan Sales, LLC v. Apotex, Inc., 12-0178 (E.D. Tex.)

Apr. 4, 2012

Hon. Rodney Gilstrap

Acular LS®(ketorolac tromethamine ophthalmic solution, 0.4%)

8,008,338

Sanofi-Aventis U.S. LLC v. Strides, Inc., 12-2070 (D.N.J.)

Apr. 5, 2012

Hon. Joel A. Pisano

Eloxatin®(oxaliplatin injection)

5,338,874

5,716,988

Abbott Labs. v. Roxane Labs., Inc., 12-0457 (D. Del.)

Apr. 10, 2012

Hon. Christopher J. Burke

Norvir®(ritonavir tablets)

7,148,359

7,364,752

5,648,497

Depomed, Inc. v. Impax Labs., Inc., 12-2154 (D.N.J.)

Apr. 10, 2012

Hon. Joel A. Pisano

Gralise®(gabapentin tablets)

6,340,475

6,488,962

6,635,280

6,723,340

7,438,927

7,731,989

Roxane Labs., Inc., v. Abbott Labs., 12-0312 (S.D. Ohio)

Apr. 10, 2012

Hon. Michael H. Watson

Norvir®(ritonavir tablets)

7,148,359

7,364,752

Purdue Pharma L.P. v. Varam, Inc., 12-2814 (S.D.N.Y.)

Apr. 10, 2012

Hon. Sidney H. Stein

OxyContin®(oxycodone hydrochloride extended release tablets)

5,508,042

7,674,799

7,674,800

7,683,072

AstraZeneca Pharma.

LP v. IntelliPharmaCeutics Corp., 12-2855 (S.D.N.Y.)

Apr. 11, 2012

Hon. Richard J. Sullivan

Seroquel XR®(quetiapine fumurate extended release tablets)

5,948,437

UCB, Inc. v. Mallinckrodt, Inc., 12-0463 (D. Del.)

Apr. 12, 2012

Hon. Leonard P. Stark

Metadate CD®(methylphenidate hydrochloride capsules)

6,344,215

Purdue Pharma L.P. v. Varam, Inc., 12-1898 (E.D. Pa.)

Apr. 12, 2012

Hon Petrese B. Tucker

OxyContin®(oxycodone hydrochloride extended release tablets)

5,508,042

7,674,799

7,674,800

7,683,072

Osi Pharma., LLC v. Roxane Labs., Inc., 12-0465 (D. Del.)

Apr. 13, 2012

Hon. Sue L. Robinson

Tarceva®(erlotinib hydrochloride tablets)

RE41,065

6,900,221

7,087,613

Pfizer, Inc. v. Dr. Reddy’s Labs., Ltd., 12-0467 (D. Del.)

Apr. 13, 2012

Hon. Leonard P. Stark

Caduet®(amlodipine besylate and atorvastatin calcium tablets)

6,455,574

Allergan, Inc. v. Sandoz, Inc., 12-0207 (E.D. Tex.)

Apr. 13, 2012

Hon. Rodney Gilstrap

Combigan®(brimonidine tartrate/timolol maleate ophthalmic solution, 0.2%/0.5%)

8,133,890

Purdue Pharma L.P. v. Mylan Pharma.

Inc., 12-2959 (S.D.N.Y.)

Apr. 13, 2012

Hon. Sidney H. Stein

OxyContin®(oxycodone hydrochloride extended release tablets)

7,674,799

7,674,800

7,683,072

Eli Lilly & Co. v. Apotex, Inc. 12-0499 (S.D. Ind.)

Apr. 17, 2012

Hon. Jane

Magnus-Stinson

Alimta®(pemetrexed disodium

injection)

7,772,209

Depomed, Inc. v. Watson Labs., Inc. - Florida, 12-0492 (D. Del.)

Apr. 18, 2012

Hon. Sue L. Robinson

Glumetza®(metformin hydrochloride extended release tablets)

6,488,962

7,780,987

Genzyme Corp. v. InvaGen Pharma., Inc., 12-1931 (E.D.N.Y.)

Apr. 19, 2012

Hon. Margo K. Brodie

Renvela®(sevelamer carbonate tablets

)

5,667,775

Purdue Pharma L.P. v. Watson Labs., Inc. – Florida, 12-3111 (S.D.N.Y.)

Apr. 19, 2012

Hon. Sidney H. Stein

OxyContin®(oxycodone hydrochloride extended release tablets)

8,114,383

Apotex, Inc. v. Mylan Pharma., Inc., 12-60704 (S.D. Fla.)

Apr. 20, 2012

Hon. Kathleen M. Willia

ms

Quinapril (quinapr

il hydrochloride and hydrochlorothiazide)

6,531,486

Apotex, Inc. v. Mylan Pharma., Inc., 12-60704 (S.D. Fla.)

Apr. 20, 2012

Hon. Kathleen M. Williams

quinapril hydrochloride

quinipril hydrochloride and hydrochlorothiazide

6,531,486

Apotex, Inc. v. Pfizer, Inc., 12-60705 (S.D. Fla.)

Apr. 20, 2012

Hon. K. Michael Moore

Accupril®(quinapril)

Accuretic®(hydrochlorothiazide and quinapril)

6,531,486

Apotex, Inc. v. UCB, Inc., 12-60706 (S.D. Fla.)

Apr. 20, 2012

Hon. Kathleen M. Williams

Univasc®(moexipril)

Uniretic®(moexipril HCl and hydrochlorothiazide)

6,767,556

Apotex, Inc. v. Paddock Labs., Inc., 12-60707 (S.D. Fla.)

Apr. 20, 2012

Hon. K. Michael Moore

moexipril

moexipril HCl and hydrochlrorthiazide

6,767,556

Apotex, Inc. v. Lupin Pharma., Inc., 12-60708 (S.D. Fla.)

Apr. 20, 2012

Hon. Donald M. Middlebrooks

quinapril hydrochloride

6,531,486

Genzyme Corp. v. Cobrek Pharma., Inc., 12-2937 (N.D. Ill.)

Apr. 20, 2012

Hon. Milton I. Shadur

Hectorol®(doxercalciferol injection)

5,602,116

Osi Pharma., LLC v. Roxane Labs., Inc., 12-2384 (D.N.J.)

Apr. 20, 2012

Hon. Dennis M. Cavanaugh

Tarceva®(erlotinib hydrochloride tablets)

RE41,065

6,900,221

7,087,613

Bayer Pharma AG v. Watson Pharma., Inc., 12-0517 (D. Del.)

Apr. 25, 2012

Hon. Gregory M. Sleet

Staxyn®(vardenafil HCl orally disintegrating tablets)

6,362,178

7,696,206

Abbott Labs. V. Agila Specialties Private Ltd., 12-0520 (D. Del.)

Apr. 25, 2012

Hon. Gregory M. Sleet

Zemplar®(paricalcitol injection)

6,136,799

6,361,758

5,597,815

Orion Corp. v. Mylan Pharma., Inc., 12-0523 (D. Del.)

Apr. 26, 2012

Hon. Gregory M. Sleet

Stalevo®(carbidopa, levodopa, and entacapone tablets)

5446194

6500867

6797732

Warner Chilcott Co., LLC v. Ranbaxy, Inc., 12-2474 (D.N.J.)

Apr. 26, 2012

Hon. Faith S. Hochberg

Atelvia®(risedronate sodium delayed release tablets)

7,645,459

7,645,460

Otsuka Pharma. Co., Ltd. v. Amneal Pharma., LLC, 12-2487 (D.N.J.)

Apr. 26, 2012

Hon. Mary L. Cooper

Abilify®(aripiprazole oral solution)

6,977,257

Teva Neuroscience, Inc. v. Sandoz Inc., 12-2494 (D.N.J.)

Apr. 26, 2012

Hon. Claire C. Cecchi

Azilect®(rasagiline mesylate tablets)

5,453,446

Valeant International (Barbados) SRL v. Sandoz, Inc., 12-0536 (D. Del.)

Apr. 30, 2012

Hon. Sherry R. Fallon

Aplenzin®(bupropion hydrobromide extended release tablets)

7,241,805

7,569,610

7,572,935

7,585,897

7,645,802

7,649,019

7,662,407

7,671,094

7,553,992

Shire Development LLC v. Watson Pharma., Inc., 12-60862 (S.D. Fla.)

May 8, 2012

Hon. Donald M. Middlebrooks

Lialda®(mesalamine delayed release tablets)

6,773,720

Depomed, Inc. v. Zydus Pharma.

(USA), Inc., 12-2813 (D.N.J.)

May 9, 2012

Hon. Joel A. Pisano

Gralise®(gabapentin tablets)

6,340,475

6,488,962

6,635,280

6,723,340

7,438,927

7,731,989

Janssen Products, L.P. v. Lupin Ltd., 12-2840 (D.N.J.)

May 10, 2012

Hon. William H. Walls

Prezista®(darunavir tablets)

RE42,889

Helsinn Healthcare S.A. v. Dr. Reddy’s Labs., Ltd., 12-2867 (D.N.J.)

May 11, 2012

Hon. Mary L. Cooper

Aloxi®(palonosetron hydrochloride intravenous solutions)

7,947,724

Novartis Pharma. Corp. v. Lupin Ltd., 12-0595 (D. Del.)

May 14, 2012

Hon. Sue L. Robinson

Exforge HCT®(amlodipine besylate, valsartan, and hydrochlorothiazide tablets)

6,294,197

8,101,599

Novartis Pharma. Corp. v. Torrent Pharma. Ltd., 12-0596 (D. Del.)

May 14, 2012

Hon. Sue L. Robinson

Exforge HCT®(amlodipine besylate, valsartan, and hydrochlorothiazide tablets)

6,294,197

8,101,599

Warner Chilcott Co., LLC v. Watson Labs., Inc., 12-2928 (D.N.J.)

May 16, 2012

Hon. Joel A. Pisano

Lo Loestrin®Fe (norethindrone acetate and ethinyl estradiol tablets)

5,552,394

7,704,984

Allergan, Inc. v. Hi-Tech Pharmacal Co., Inc., 12-0492 (M.D.N.C.)

May 16, 2012

Hon. Catherine C. Eagles

Latisse®(bimatoprost topical solution, 0.03%)

8,101,161

Cumberland Pharma.

Inc. v. Innopharma, Inc., 12-0618 (D. Del.)

May 17, 2012

Hon. Leonard P. Stark

Acetadote®(acetylcysteine for injection)

8,148,356

Cumberland Pharma. Inc. v. Paddock Labs., LLC, 12-0619 (D. Del.)

May 17, 2012

Hon. Leonard P. Stark

Acetadote®(acetylcysteine for injection)

8,148,356

Cumberland Pharma.

Inc. v. Mylan Institutional LLC, 12-3846 (N.D. Ill.)

May 17, 2012

Hon. Rebecca R. Pallmeyer

Acetadote®(acetylcysteine for injection)

8,148,356

Janssen Pharma., Inc. v. Haupt Pharma., Inc., 12-3034 (D.N.J.)

May 22, 2012

Hon. Stanley R. Chessler

Ortho Tri-Cyclen®LO (norgestimate and ethinyl estradiol)

6,214,815

Astellas US LLC v. Hospira, Inc., 12-0652 (D. Del.)

May 23, 2012

Hon. Sue L. Robinson

Adenoscan®(adenosine for injection)

5,731,296

Auxilium Pharma., Inc. v. Watson Labs., Inc.

(NV), 12-3084 (D.N.J.)

May 23, 2012

Hon. Jose L. Linares

Testim®(testosterone 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

Pfizer Inc. v. Sandoz Inc., 12-0654 (D. Del.)

May 24, 2012

Hon. Gregory M. Sleet

Torisel®(temsirolimus for injection)

8,026,276

Shire Development, LLC v. Mylan Pharma., Inc., 12-1190 (M.D. Fla.)

May 25, 2012

Hon. James S. Moody, Jr.

Lialda®(mesalamine delayed release tablets)

6,773,720

Merck Sharp & Dohme Corp. v. Sandoz Inc., 12-3289 (D.N.J.)

May 31, 2012

Hon. Peter G. Sheridan

Emend®(fosaprepitant dimeglumine for injection)

5,691,336

5,716,942

Merck Sharp & Dohme Corp. v. Accord Healthcare, Inc. USA, 12-3324 (D.N.J.)

June 1, 2012

Hon. Peter G. Sheridan

Emend®(fosaprepitant dimeglumine for injection)

5,691,336

5,716,942

Abbott Labs. v. Kremers Urban Pharma., Inc., 12-0703 (D. Del.)

June 1, 2012

Hon. Sue L. Robinson

Niaspan®(niacin extended release tablets)

6,080,428

6,469,035

Medicis Pharma. Corp. v. Zydus Pharma. USA Inc., 12-0707 (D. Del.)

June 4, 2012

Hon. Leonard P. Stark

Solodyn®(minocycline HCl extended release tablets)

5,908,838

7,790,705

7,919,483

Medicis Pharma. Corp. v. Zydus Pharma. USA Inc., 12-3368 (D. Del.)

June 5, 2012

Hon. Freda L. Wolfson

Solodyn®(minocycline HCl extended release tablets)

5,908,838

7,790,705

7,919,483

Janssen Products, L.P. v. Teva Pharma. USA, Inc., 12-3569 (D.N.J.)

June 13, 2012

Hon. William H. Walls

Prezista®(darunavir)

RE42,889

Janssen Products, L.P. v. Hetero Drugs, Ltd., 12-3570 (D.N.J.)

June 13, 2012

Hon. William H. Walls

Prezista®(darunavir)

RE42,889

Bristol-Myers Squibb Co. v. Sandoz Inc., 12-0787 (D. Del.)

June 21, 2012

Hon. Richard G. Andrews

Baraclude®(entecavir tablets)

5,206,244

Pfizer Inc. v. Anchen Pharma., Inc., 12-0808 (D. Del.)

June 22, 2012

Unassigned

Pristiq®(O-desmethylvenlafaxine succinate extended release tablets)

6,673,838

Pfizer Inc. v. Apotex, Inc., 12-0809 (D. Del.)

June 22, 2012

Unassigned

Pristiq®(O-desmethylvenlafaxine succinate extended release tablets)

6,673,838

Pfizer Inc. v. Breckenridge Pharmaceitucal, Inc., 12-0810 (D. Del.)

June 22, 2012

Unassigned

Pristiq®(O-desmethylvenlafaxine succinate extended release tablets)

6,673,838

Pfizer Inc. v. Lupin Ltd., 12-0811 (D. Del.)

June 22, 2012

Unassigned

Pristiq®(O-desmethylvenlafaxine succinate extended release tablets)

6,673,838

Pfizer Inc. v. Mylan Pharma. Inc., 12-0812 (D. Del.)

June 22, 2012

Unassigned

Pristiq®(O-desmethylvenlafaxine succinate extended release tablets)

6,673,838

Pfizer Inc. v. Roxane Labs. Inc., 12-0813 (D. Del.)

June 22, 2012

Unassigned

Pristiq®(O-desmethylvenlafaxine succinate extended release tablets)

6,673,838

Pfizer Inc. v. Sandoz Inc., 12-0814 (D. Del.)

June 22, 2012

Unassigned

Pristiq®(O-desmethylvenlafaxine succinate extended release tablets)

6,673,838

Pfizer Inc. v. Teva Pharma. USA Inc., 12-0815 (D. Del.)

June 22, 2012

Unassigned

Pristiq®(O-desmethylvenlafaxine succinate extended release tablets)

6,673,838

Pfizer Inc. v. Watson Labs. Inc.—Florida, 12-0816 (D. Del.)

June 22, 2012

Unassigned

Pristiq®(O-desmethylvenlafaxine succinate extended release tablets)

6,673,838

Pfizer Inc. v. Wockhardt Ltd., 12-0817 (D. Del.)

June 22, 2012

Unassigned

Pristiq®(O-desmethylvenlafaxine succinate extended release tablets)

6,673,838

Pfizer Inc. v. Zydus Pharma. USA Inc., 12-0818 (D. Del.)

June 22, 2012

Unassigned

Pristiq®(O-desmethylvenlafaxine succinate extended release tablets)

6,673,838

Pfizer Inc. v. Sandoz Inc., 12-3880 (D.N.J.)

June 25, 2012

Hon. Peter G. Sheridan

Pristiq®(O-desmethylvenlafaxine succinate extended release tablets)

6,673,838

Pfizer Inc. v. Zydus Pharma. USA Inc., 12-3893 (D.N.J.)

June 25, 2012

Hon. Peter G. Sheridan

Pristiq®(O-desmethylvenlafaxine succinate extended release tablets)

6,673,838

Pfizer Inc. v. Watson Labs. Inc.—Florida, 12-61268 (S.D. Fla.)

June 25, 2012

Hon. Robin S. Rosenbaum

Pristiq®(O-desmethylvenlafaxine succinate extended release tablets)

6,673,838

Pfizer Inc. v. Anchen Pharma., Inc., 12-5535 (C.D. Cal.)

June 25, 2012

Hon. George H. King

Pristiq®(O-desmethylvenlafaxine succinate extended release tablets)

6,673,838

Galderma Labs. L.P. v. Actavis Mid Atlantic LLC, 12-2038 (N.D. Tex.)

June 26, 2012

Hon. A. Joe Fish

Epiduo®(adapalene and benzoyl peroxide gel)

7,820,186

7,964,202

8,071,644

8,080,537

8,105,618

8,129,362

Pfizer Inc. v. Mylan Pharma. Inc., 12-0106 (N.D.W.V.)

June 26, 2012

Hon. Irene M. Keeley

Pristiq®(O-desmethylvenlafaxine succinate extended release tablets)

6,673,838

Cumberland Pharma. Inc. v. Sagent Agila LLC, 12-0825 (D. Del.)

June 26, 2012

Unassigned

Acetadote®(acetylcysteine for injection)

8,148,356

Novartis Pharma. Corp. v. Wockhardt USA LLC, 12-3967 (D.N.J.)

June 27, 2012

Hon. Susan D. Wigenton

Reclast®(zoledronic acid for injection)

Zometa®(zoledronic acid for injection)

7,932,241

8,052,987

Purdue Pharma L.P. v. Sandoz, Inc., 12-5082 (S.D.N.Y.)

June 28, 2012

Unassigned

OxyContin®(oxycodone hydrochloride extended release tablets)

8,114,383

Purdue Pharma L.P. v. Teva Pharma. USA, Inc., 12-5083 (S.D.N.Y.)

June 28, 2012

Unassigned

OxyContin®(oxycodone hydrochloride extended release tablets)

8,114,383

Endo Pharma. Inc. v. Noven Pharma., Inc., 12-0831 (D. Del.)

June 29, 2012

Unassigned

Lidoderm®(lidocaine transdermal)

5,827,529

Alkermes Pharma Ireland Ltd. v. Intellipharmaceutics Corp., 12-0834 (D. Del.)

June 29, 2012

Unassigned

Focalin®XR (dexmethylphenidate hydrochloride capsules)

6,228,398

6,730,325

Abbott Labs. v. Sandoz, Inc., 12-0836 (D. Del.)

June 29, 2012

Unassigned

Zemplar®(paricalcitol capsules)

5,587,497

5,597,815


Ryan M. Schultz

Partner

Pronouns: he/him

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