New ANDA Cases

2011/2012

GENERICally Speaking: A Hatch Waxman Litigation Bulletin
Case Name Date Filed Judge Drug Patent No(s).

Eisai Inc. v. BannerPharmacapsInc., 11-901 (D. Del.)

Oct. 4, 2011

Hon. Gregory M. Sleet

Targretin®(bexarotine capsules)

5,780,676

5,962,731

Pfizer Inc. v. Watson Pharma., Inc. , 11-914 (D. Del.)

Oct. 6, 2011

Hon. Berle M. Schiller

Embeda®(morphine sulfate/naltrexone hydrochloride extended-release capsules)

7,682,633

7,682,634

7,815,934

Pfizer Inc. v. Watson Pharma., Inc. , 11-5860 (D.N.J.)

Oct. 7, 2011

Hon. Claire C. Cecchi

Embeda®(morphine sulfate/naltrexone hydrochloride extended-release capsules)

7,682,633

7,682,634

7,815,934

Novartis Pharma. Corp. v. Alembic Pharma. Ltd. , 11-7092 (S.D.N.Y.)

Oct. 7, 2011

Hon. Harold Baer

Exelon®(rivastigmine tartrate capsules)

5,602,176

Purdue Pharma L.P. v. Ranbaxy, Inc. , 11-7104 (S.D.N.Y.)

Oct. 7, 2011

Hon. Sidney H. Stein

OxyContin®(oxycodone hydrochloride extended release tablet)

7,674,799

7,674,800

7,683,072

Senju Pharma. Co., Ltd. v. Hi-Tech Pharmacal Co., Inc. , 11-1059 (D. Del.)

Oct. 11, 2011

Hon. Sue L. Robinson

Zymaxid®(gatifloxacin ophthalmic solution, 0.5%)

6,333,045

5,880,283

Warner Chilcott Co., LLC v. Watson Pharma., Inc. , 11-5989 (D.N.J.)

Oct. 12, 2011

Hon. Faith S. Hochberg

Atelvia®(risedronate sodium delayed release tablets)

7,645,459

7,645,460

Noven Pharma., Inc. v. Watson Labs., Inc. , 11-5997 (D.N.J.)

Oct. 13, 2011

Hon. Dennis M. Cavanaugh

Daytrana® (methylphenidate transdermal patch)

6,210,705

6,348,211

Schering Corp. v. Actavis Inc. , 11-6067 (D.N.J.)

Oct. 13, 2011

Hon. Jose L. Linares

Vytorin®(ezetimibe/simvastatin tablets)

RE42,461

5,846,966

Alcon Pharma., Ltd. v. Perrigo Co. , 11-0732 (N.D. Tex. )

Oct. 14, 2011

Hon. Terry R. Means

Patanase®(olopatadinehydrochloride nasal spray, 0.665%)

7,977,376

Novo Nordisk Inc. v. SandozInc., 11-6106 (D.N.J.)

Oct. 14, 2011

Hon. Freda L. Wolfson

Prandin®(repaglinide tablets)

6,677,358

Janssen Pharma., Inc. v. Sun Pharma Global FZE , 11-6089 (D.N.J.)

Oct. 17, 2011

Hon. Stanley R. Chesler

Ortho Tri-cyclen®LO (norgestimate/ethinyl estradiol tablets)

6,214,815

Alkermes Pharma Ireland Ltd. v. Torrent Pharma. Ltd. , 11-1009 (D. Del.)

Oct. 21, 2011

Hon. Gregory M. Sleet

Luvox CR®(fluvoxamine maleate extended-release capsules)

7,465,462

AstraZeneca AB v. AnchenPharma., Inc., 11-6348 (D.N.J.)

Oct. 28, 2011

Hon. Joel A. Pisano

Vimovo®(naproxen and esomeprazole magnesium delayed release tablets)

6,926,907

6,369,085

7,411,070

7,745,466

Abbott Products, Inc. v. Perrigo Co. , 11-6357 (D.N.J.)

Oct. 31, 2011

Hon. Freda L. Wolfson

AndroGel®(testosterone gel)

6,503,894

Senju Pharma. Co., Ltd. v. Hi-Tech Pharmacal Co., Inc. , 11-1059 (D. Del.)

Oct. 31, 2011

Hon. Sue L. Robinson

Zymar®(gatifloxacin ophthalmic solution, 0.3%))

6,333,045

5,880,283

Cephalon, Inc. v. Breckenridge Pharma., Inc. , 11-1070 (D. Del.)

Nov. 2, 2011

Hon. Gregory M. Sleet

Nuvigil®(armodifinil tablets)

7,132,570

Cephalon, Inc. v. Breckenridge Pharma., Inc. , 11-6455 (D.N.J.)

Nov. 3, 2011

Hon. Jose L. Linares

Nuvigil®(armodifinil tablets)

7,132,570

Novartis Pharma. Corp. v. Actavis South Atlantic LLC , 11-1077 (D. Del.)

Nov. 3, 2011

Hon. Sue L. Robinson

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

5,602,176

6,316,023

6,335,031

Novartis Pharma. Corp. v. Actavis South Atlantic LLC , 11-62371 (S.D. Fla. )

Nov. 4, 2011

Hon. William P. Dimitrouleas

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

5,602,176

6,316,023

6,335,031

Celgene Corp. v. Actavis South Atlantic LLC , 11-6519 (D.N.J.)

Nov. 4, 2011

Hon. Susan D. Wigenton

Focalin®XR (dexmethylphenidate hydrochloride capsules)

5,908,850

6,355,656

6,528,530

5,837,284

6,635,284

7,431,944

Alkermes Pharma Ireland Ltd. v. Actavis, Inc., 11-1098 (D. Del.)

Nov. 4, 2011

Hon. Sue L. Robinson

Focalin®XR (dexmethylphenidate hydrochloride capsules)

6,228,398

6,730,325

Warner Chilcott Co., LLC v. Zydus Pharma.(USA) Inc., 11-1105 (D. Del.)

Nov. 8, 2011

Hon. Richard G. Andrews

Asacol®HD (mesalamine delayed-release oral tablet)

6,893,662

Galderma Labs. Inc. v. AmnealPharma., LLC, 11-1106 (D. Del.)

Nov. 8, 2011

Hon. Leonard P. Stark

Oracea®(doxycycline delayed-release capsules)

7,749,532

7,232,572

7,211,267

Cephalon, Inc. v. Mylan Pharma.Inc., 11-1111 (D. Del.)

Nov. 9, 2011

Hon. Sue L. Robinson

Fentora®(fentanyl buccal tablets)

6,200,604

6,974,590

7,862,832

7,862,833

Novartis Pharma. Corp. v. Watson Labs. Inc. , 11-1112 (D. Del.)

Nov. 9, 2011

Hon. Sue L. Robinson

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

5,602,176

6,316,023

6,335,031

Abbott Labs. v. SandozInc., 11-1113 (D. Del.)

Nov. 9, 2011

Hon. Sue L. Robinson

Simcor®(niacin extended release/simvastatin tablets)

6,080,428

6,469,035

Reckitt Benckiser LLC v. Amneal Pharma. LLC , 11-6609 (D.N.J.)

Nov. 9, 2011

Hon. Joel A. Pisano

Delsym®(dextromethorphan polistirex extended release liquid suspension)

5,980,882

Novartis Pharma.Corp. v. Watson Labs. Inc. , 11-8130 (S.D.N.Y.)

Nov. 10, 2011

Hon. Harold Baer

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

5,602,176

6,316,023

6,335,031

Purdue Pharma L.P. v. Amneal Pharma., L.L.C. , 11-8153 (S.D.N.Y.)

Nov. 10, 2011

Hon. Sidney H. Stein

OxyContin®(oxycodone hydrochloride extended release tablet)

7,674,799

7,674,800

7,683,072

7,776,314

Celgene Corp. v. ParPharma., Inc., 11-6640 (D.N.J.)

Nov. 10, 2011

Hon. Susan D. Wigenton

Focalin®XR (dexmethylphenidate hydrochloride capsules)

5,908,850

6,355,656

6,528,530

5,837,284

6,635,284

7,431,944

Alkermes Pharma Ireland Ltd. v. ParPharma., Inc., 11-1119 (D. Del.)

Nov. 11, 2011

Hon. Sue L. Robinson

Focalin®XR (dexmethylphenidate hydrochloride capsules)

6,228,398

6,730,325

Allergan, Inc. v. LupinLtd., 11-611 (E.D. Tex.)

Nov. 11, 2011

Hon. Michael H. Schneider

Lumigan®(bimatoprost ophthalmic solution 0.01%)

7,851,504

Aventis Pharma S.A. v. Strides, Inc., 11-1121 (D. Del.)

Nov. 14, 2011

Hon. Gregory M. Sleet

Taxotere®(docetaxel injection)

5,714,512

5,750,561

Takeda Pharma. Co. Ltd. v. HeteroDrugsLtd., 11-8302 (S.D.N.Y.)

Nov. 16, 2011

Hon. Denise L. Cote

Actos®(pioglitazone

hydrochloride tablets)

5,965,584

6,329,404

6,166,043

Cephalon, Inc. v. ImpaxLabs., Inc., 11-1152 (D. Del.)

Nov. 18, 2011

Hon. Sue L. Robinson

Fentora®(fentanyl buccaltablets)

6,200,604

6,974,590

7,862,832

7,862,833

The Medicines Co. v. Sun Pharma Global FZE , 11-6819 (D.N.J.)

Nov. 21, 2011

Hon. Peter G. Sheridan

Angiomax®(bivalirudin intravenous injection)

7,582,727

7,598,343

Warner Chilcott Co., LLC v. Mylan Inc. , 11-6844 (D.N.J.)

Nov. 22, 2011

Hon. Joel A. Pisano

Generess™ Fe (norethindrone and ethinyl estradiol chewable tablet)

6,667,050

Warner Chilcott Co., LLC v. Teva Pharma. USA Inc. , 11-6936 (D.N.J.)

Nov. 22, 2011

Hon. Faith S. Hochberg

Atelvia®(risedronate sodium delayed release tablets)

7,645,459

7,645,460

Bristol-Myers Squibb Co. v. Apotex Inc. , 11-6918 (D.N.J.)

Nov. 23, 2011

Hon. Mary L. Cooper

Sprycel®(dasatinib tablet)

6,596,746

7,125,875

7,153,856

7,491,725

The Medicines Co. v. Sun Pharma Global FZE , 11-15175 (E.D. Mich.)

Nov. 23, 2011

Hon. Bernard A. Friedman

Angiomax®(bivalirudin intravenous injection)

7,582,727

7,598,343

Ferring B.V. v. Watson Pharma., Inc. , 11-853 (D. Nev.)

Nov. 25, 2011

Hon. Larry R. Hicks

Lysteda®(tranexamic acid tablets)

8,022,106

Ferring B.V. v. Apotex, Inc. , 11-854 (D. Nev.)

Nov. 25, 2011

Hon. Larry R. Hicks

Lysteda®(tranexamic acid tablets)

8,022,106

Senju Pharma. Co., Ltd. v. ApotexInc., 11-1171 (D. Del.)

Nov. 28, 2011

Hon. Sue L. Robinson

Zymaxid®(gatifloxacin ophthalmic solution, 0.5%)

6,333,045

Alkermes Pharma Ireland Ltd. v. Teva Pharma. USA Inc., 11-1186 (D. Del.)

Dec. 1, 2011

Hon. Sue L. Robinson

Focalin®XR (dexmethylphenidate hydrochloride capsules)

6,228,398

6,730,325

Abbott Labs. v. Sun Pharma. Indus. Ltd. , 11-1190 (D. Del.)

Dec. 2, 2011

Hon. Sue L. Robinson

Niaspan®(niacin extended release tablet)

6,129,930

6,406,715

6,676,967

6,746,691

6,818,229

7,011,848

Abbott Labs. v. Wockhardt, Ltd. , 11-7046 (D.N.J.)

Dec. 2, 2011

Hon. Dennis M. Cavanaugh

Tricor®(fenofibrate tablet)

6,277,405

7,037,529

7,041,319

Alkermes Pharma Ireland Ltd. v. Wockhardt, Ltd. , 11-7047 (D.N.J.)

Dec. 2, 2011

Hon. Jose L. Linares

Tricor®(fenofibrate tablet)

7,276,249

7,320,802

Celgene Corp. v. Teva Pharma. USA, Inc. , 11-7064 (D.N.J.)

Dec. 2, 2011

Hon. Susan D. Wigenton

Focalin®XR (dexmethylphenidate hydrochloride capsules)

5,908,850

6,355,656

6,528,530

5,837,284

6,635,284

7,431,944

Pfizer Inc. v. AlembicLtd, 11-1213 (D. Del.)

Dec. 7, 2011

Hon. Gregory M. Sleet

Lyrica®(pregabalin capsules)

6,197,819

Alza Corp. v. MylanPharmaInc., 11-7158 (D.N.J.)

Dec. 8, 2011

Hon. Esther Salas

Glucotrol®XL (glipizide extended release tablets)

5,591,454

Warner Chilcott Co. LLC v. Lupin Ltd. , 11-7228 (D.N.J.)

Dec. 12, 2011

Hon. Joel A. Pisano

Generess™ Fe (norethindrone and ethinyl estradiol chewable tablet)

6,667,050

Janssen Pharma. Inc. v. Sandoz, Inc. , 11-7247 (D.N.J.)

Dec. 13, 2011

Hon. Freda L. Wolfson

Doribax®(doripenem injection)

5,317,016

Cephalon, Inc. v. Celgene Corp. , 11-12226 (D. Mass.)

Dec. 14, 2011

Hon. George A. O’Toole, Jr.

Abraxane®(paclitaxelinjection)

RE40,493

Pfizer Inc. v. Sandoz Inc. , 11-1252 (D. Del.)

Dec. 15, 2011

Hon. Gregory M. Sleet

Torisel®(temsirolimus injection)

5,362,718

Pfizer Inc. v. Intas Pharma. Ltd. , 11-1253 (D. Del.)

Dec. 15, 2011

Hon. Leonard P. Stark

Torisel®(temsirolimus injection)

5,362,718

Shire LLC v. Mylan Pharma. Inc. , 11-0201 (N.D. W. Va. )

Dec. 15, 2011

Hon. Irene M. Keeley

Intuniv®(guanfacine hydrochloride extended-release tablets)

6,287,599

6,811,794

5,854,290

Roche Palo Alto LLC v. Dr.Reddy’sLabs., Ltd., 11-1264 (D. Del.)

Dec. 20, 2011

Hon. Gregory M. Sleet

Valcyte®(valganciclovir hydrochloride)

6,083,953

Allergan, Inc. v. Akorn, Inc. , 11-1270 (D. Del.)

Dec. 21, 2011

Hon. Christopher J. Burke

Acuvail®(ketorolac tromethamine ophthalmic solution, 0.45%)

7,842,714

MSD Consumer Products, Inc. v. Zydus Pharma. (USA) Inc., 11-7437 (D.N.J.)

Dec. 21, 2011

Hon. Peter G. Sheridan

Zegerid OTC™ (omeprazole/sodium bicarbonate capsules)

6,699,885

6,489,346

6,645,988

7,399,772

Santarus, Inc. v. ZydusPharma.(USA) Inc., 11-7441 (D.N.J.)

Dec. 21, 2011

Hon. Peter G. Sheridan

Zegerid Rx™ (omeprazole/sodium bicarbonate capsules)

6,699,885

6,489,346

6,645,988

7,399,772

GlaxoSmithKline Intellectual Property Management Ltd. v. Sandoz, Inc. , 11-1284 (D. Del.)

Dec. 23, 2011

Hon. Richard G. Andrews

Veramyst®(fluticasone fuorate metered nasal spray)

6,858,596

7,101,866

7,541,350

Merck Frosst Canada & Co. v. Mylan Pharma. Inc. , 11-7569 (D.N.J.)

Dec. 29, 2011

Hon. Freda L. Wolfson

Singulair®(montelukast sodium oral granules eq. to 4 ml base/packet)

8,007,830

Allergan, Inc. v. Lupin Ltd. , 11-0530 (E.D. Tex.)

Dec. 30, 2011

Hon. David Folsom

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

8,008,338


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