New ANDA Cases

Spring 2012

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name

Date Filed

Judge

Drug

Patent No(s).

Takeda Pharma. Co. Ltd. v. Mylan, Inc., 12-0024 (S.D.N.Y.)

Jan. 3, 2012

Hon. Denise L. Cote

Actoplus Met®XR (pioglitazone HCl/metforminHCl extended-release)

5,965,584

6,099,859

6,166,043

6,172,090

6,495,162

6,790,459

6,866,866

7,785,627

7,919,116

7,959,946

Shire LLCv. Sandoz, Inc., 12-0040 (D. Col.)

Jan. 6, 2012

Hon. Marcia S. Krieger

Intuniv®(quanfacine hydrocholoride extended-release tablet)

5,854,290

6,287,599

6,811,794

Takeda Pharma. Co. Ltd. v. Mylan, Inc., 12-0026 (W.D. Pa.)

Jan. 6, 2012

Hon. Arthur J. Schwab

Actoplus Met®XR (pioglitazone HCl/metforminHCl extended-release)

5,965,584

6,099,859

6,166,043

6,172,090

6,495,162

6,790,459

6,866,866

7,785,627

7,919,116

7,959,946

Merck Frosst Canada & Co. v. Teva Pharma. USA Inc., 12-0210 (D.N.J.)

Jan. 11, 2012

Hon. Freda L. Wolfson

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

8,007,830

Meda Pharma. Inc. v. ApotexInc., 12-0361 (D.N.J.)

Jan. 19, 2012

Hon. Peter G. Sheridan

Astepro®(azelastine hydrochloride nasal spray)

8,071,073

Abbott Labs. v. CadilaHealthcareLtd., 12-0065 (D. Del.)

Jan. 20, 2012

Hon. Sue L. Robinson

Niaspan®(niacin extended-release tablet)

6,080,428

Spectrum Pharma. Inc. v. Sandoz Inc., 12-0111 (D. Nev.)

Jan. 20, 2012

Hon. Larry R. Hicks

Fusilev®(levoleucovorin for injection)

6,500,829

Eli Lilly & Co. v. Accord Healthcare, Inc., USA, 12-0086 (S.D. Ind.)

Jan. 20, 2012

Hon. Richard L. Young

Alimta®(pemetrexed disodium for injection)

7,772,209

Cephalon, Inc. v. MylanPharma.Inc., 12-0073 (D. Del.)

Jan. 24, 2012

Hon. Sue L. Robinson

Fentora®(fentanyl buccal tablet)

8,092,832

Cephalon, Inc. v. Sandoz, Inc., 12-0074 (D. Del.)

Jan. 24, 2012

Hon. Sue L. Robinson

Fentora®(fentanyl buccal tablet)

8,092,832

AstraZeneca AB v. TorrentPharma.Ltd., 12-0506 (D.N.J.)

Jan. 26, 2012

Hon. Joel A. Pisano

Nexium®(esomeprazole magnesium delayed-release capsules)

5,714,504

5,877,192

6,875,872

Valeant Int’l (Barbados) SRL v. SpearPharma., Inc., 12-0043 (M.D. Fla.)

Jan. 26, 2012

Hon. John E. Steele

Carac®(fluorouracil topical cream 0.5%)

6,670,335

Allergan, Inc. v. Hi-Tech Pharmacal Co., 12-0043 (E.D. Tex.)

Jan. 27, 2012

Hon. Michael H. Schneider

Lumigan®(bimatoprost ophthalmic solution, 0.01%)

7,851,504

Takeda Pharma. Co., Ltd. v. Sandoz Inc., 12-0446 (N.D. Cal.)

Jan. 27, 2012

Hon. Joseph C. Spero

Dexilant®(dexlansoprazole delayed-release capsules)

6,462,058

6,664,276

6,939,971

7,285,668

7,790,755

Abbott Labs. v. Sandoz, Inc., 12-0103 (D. Del.)

Jan. 30, 2012

Hon. Sue L. Robinson

Simcor®(niacin and simvastatin tablets)

6,080,428

6,469,035

Shire LLC v. Mylan Pharma. Inc., 12-0638 (D.N.J.)

Feb. 2, 2012

Hon. Stanley R. Chesler

Vyvanse®(lisdexamfetamine dimesylate capsule)

7,105,486

7,223,735

7,655,630

7,659,253

7,659,254

7,662,787

7,671,030

7,671,031

7,674,774

7,678,770

7,678,771

7,687,466

7,687,467

7,718,619

7,723,305

Purdue Pharma L.P. v. Sandoz Inc., 12-0897 (S.D.N.Y.)

Feb. 3, 2012

Hon. Sidney H. Stein

OxyContin®(controlled-release oxycodone)

6,488,963

7,674,799

7,674,800

7,683,072

7,776,314

Senju Pharma. Co., Ltd. v. ApotexInc., 12-0159 (D. Del.)

Feb. 10, 2012

Hon. Sue L. Robinson

Zymaxid®(gatifloxacin ophthalmic solution 0.5%)

5,880,283

6,333,045

Merck & CIE v. WatsonPharma., Inc., 12-0161 (D. Del.)

Feb. 10, 2012

Hon. Richard G. Andrews

Beyaz®(drospirenone/ethinyl estradiol/levomefolate calcium tablets and Levomefolate calcium tablets)

6,441,168

Merck & CIE v. WatsonPharma., Inc., 12-0223 (D. Nev.)

Feb. 13, 2012

Hon. Larry R. Hicks

Beyaz®(drospirenone/ethinyl estradiol/levomefolate calcium tablets and Levomefolate calcium tablets)

6,441,168

Novo Nordisk Inc. v. AurobindoPharmaLtd., 12-1026 (D.N.J.)

Feb. 16, 2012

Hon. Freda L. Wolfson

Prandin®(repaglinide tablets)

6,677,358

Spectrum Pharma, Inc. v. Innopharma, Inc., 12-0265 (D. Nev.)

Feb. 17, 2012

Hon. Gloria M. Navarro

Fusilev®(levoleucovorin for injection)

6,500,829

Abbott Labs. v. Hospira, Inc., 12-0234 (D. Del.)

Feb. 27, 2012

Hon. Gregory M. Sleet

Zemplar®(paricalcitolfor injection)

5,597,815

Abbott Labs. v. AmnealPharma., LLC, 12-0235 (D. Del.)

Feb. 27, 2012

Hon. Sue L. Robinson

Niaspan®(niacin extended release tablets)

6,080,428

Nautilus Neurosciences, Inc. v. Wockhardt USA LLC, 12-1243 (D.N.J.)

Feb. 27, 2012

Hon. Esther Salas

Cambia®(diclofenac potassium for oral solution)

8,097,651

Cephalon, Inc. v. MylanPharma.Inc., 12-0247 (D. Del.)

Feb. 29, 2012

Hon. Sue L. Robinson

Fentora®(fentanyl citrate buccal tablets)

8,119,158

Cephalon, Inc. v. SandozInc., 12-0248 (D. Del.)

Feb. 29, 2012

Hon. Sue L. Robinson

Fentora®(fentanyl citrate buccal tablets)

8,119,158

Merck Frosst Canada & Co. v. Dr. Reddy’s Labs., Ltd., 12-1324 (D.N.J.)

Mar. 2, 2012

Hon. Freda L. Wolfson

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

8,007,830

Depomed, Inc. v. Actavis Elizabeth LLC, 12-1358(D.N.J.)

Mar. 2, 2012

Hon. Joel A. Pisano

Gralise®(gabapentin extended-release tablets)

6,340,475

6,488,962

6,635,280

6,723,340

7,438,927

7,731,989

Abbott Labs. v. Mylan Inc., 12-0257 (D. Del.)

Mar. 2, 2012

Hon. Sue L. Robinson

Niaspan®(niacin extended-release tablets)

6,080,428

6,129,930

6,406,715

6,469,035

6,676,967

6,746,691

6,818,229

7,011,848

7,998,506

Avanir Pharma., Inc. v. WatsonPharma., Inc., 12-0258 (D. Del.)

Mar. 2, 2012

Hon. Leonard P. Stark

Nuedexta®(dextromethorphan hydrobromide/quinidine sulfate capsules)

7,659,282

RE38,115

Spectrum Pharma., Inc. v. Innopharma, Inc., 12-0260 (D. Del.)

Mar. 2, 2012

Hon. Christopher J. Burke

Fusilev®(levoleucovorin)

6,500,829

AstraZeneca AB v. Mylan Labs. Ltd., 12-1378 (D.N.J.)

Mar. 6, 2012

Hon. Joel A. Pisano

Nexium®(esomeprazole magnesium capsules)

5,714,504

5,877,192

6,875,872

Avanir Pharma., Inc. v. Watson Pharma., Inc., 12-1463 (D.N.J.)

Mar. 8, 2012

Hon. William J. Martini

Nuedexta®(dextromethorphan hydrobromide/quinidine sulfate capsules)

7,659,282

RE38,115

Genzyme Corp. v. Invagen Pharma., Inc., 12-1164 (E.D.N.Y.)

Mar. 8, 2012

Hon. Jack B. Weinstein

Renagel®(sevelamer hydrochloride tablets)

5,667,775

AstraZeneca AB v. Mylan Labs.Ltd., 12-0300 (D. Del.)

Mar. 12, 2012

Hon. Mary Pat Thynge

Nexium®(esomeprazole magnesium capsules)

5,714,504

5,877,192

6,875,872

Genzyme Corp. V. Invagen Pharma., Inc., 12-1819 (S.D.N.Y.)

Mar. 12, 2012

Hon. Jed S. Rakoff

Renagel®(sevelamer hydrochloride tablets)

5,667,775

Forest Labs., Inc. v. TorrentPharma.Ltd., 12-0305 (D. Del).

Mar. 13, 2012

Hon. Sue L. Robinson

Bystolic®(nebivolol hydrochloride)

6,545,040

Allergan, Inc. v. Apotex, Inc., 12-0247 (M.D.N.C.)

Mar. 13, 2012

Hon. Catherine C. Eagles

Latisse®(bimatoprost ophthalmic solution, 0.03%)

8,038,988

8,101,161

Forest Labs., Inc. v. Indchemie Health Specialties Pvt. Ltd., 12-1855 (N.D. Ill.)

Mar. 14, 2012

Hon. Elaine E. Bucklo

Bystolic®(nebivolol hydrochloride)

6,545,040

United Therapeutics Corp. v. Sandoz, Inc., 12-1617 (D.N.J.)

Mar. 14, 2012

Hon. Peter G. Sheridan

Remodulin®(treprostinil sodium for injection)

5,153,222

6,765,117

7,999,007

Alkermes Pharma Ireland Ltd. v. Actavis, Inc., 12-0323 (D. Del.)

Mar. 16, 2012

Hon. Sue L. Robinson

Focalin®XR (dexmethylphenidate hydrochloride capsules)

6,228,398

6,730,325

Abbott Labs. v. Watson, Pharma., Inc., 12-0324 (D. Del.)

Mar. 16, 2012

Hon. Sue L. Robinson

Niaspan®(niacin extended-release tablet)

6,080,428

6,469,035

Celgene Corp. v. Actavis South Atlantic LLC, 12-1688 (D.N.J.)

Mar. 16, 2012

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

Shire Development LLC v. Osmotica Pharma. Corp., 12-0904 (N.D. Ga.)

Mar. 16, 2012

Hon. Amy Totenberg

Lialda®(mesalamine delayed-release tablets)

6,773,720

Novartis Pharma.Corp. v. Actavis Group HF., 12-0366 (D. Del.)

Mar. 21, 2012

Hon. Christopher J. Burke

Exjade®(deferasirox tablets for oral suspension)

6,465,504

6,596,750

Cubist Pharma., Inc. v. Hospira, Inc., 12-0367 (D. Del.)

Mar. 21, 2012

Hon. Gregory M. Sleet

Cubicin®(daptomycin for injection)

6,468,967

6,852,689

8,058,238

RE39,071

Novartis Pharma.Corp. v. ActavisElizabethLLC, 12-1798 (D.N.J.)

Mar. 22, 2012

Hon. Dennis M. Cavanaugh

Exjade®(deferasirox tablets for oral suspension)

6,465,504

6,596,750

Allergan, Inc. v. Watson Labs. Inc., 12-0197 (E.D. Tex.)

Mar. 23, 2012

Hon. Michael H. Schneider

Lumigan®(bimatoprost ophthalmic solution, 0.01%)

7,851,504

5,688,819

Horizon Pharma., Inc. v. Par Pharma. Companies, 12-0393 (D. Del.)

Mar. 28, 2012

Unassigned

Duexis®(ibuprofren and famotidine)

8,067,033

Eagle Pharma., Inc. v. Sandoz, Inc., 12-1938 (D.N.J.)

Mar. 30, 2012

Hon. Peter G. Sheridan

Argatroban®(argatroban injectable)

7,589,106

7,687,516

GlaxoSmithKline PLC v. Hikma Pharma.Co., Ltd., 12-1965 (D.N.J.)

Mar. 30, 2012

Hon. Freda L. Wolfson

Argatroban®(argatroban injectable)

5,214,052

Allergan, Inc. v. Watson Pharma., Inc., 12-0321 (M.D.N.C.)

Mar. 30, 2012

Unassigned

Latisse®(bimatoprost ophthalmic solution, 0.03%)

7,351,404

7,388,029

8,038,988

6,403,649

8,017,655


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