New ANDA Cases

Winter 2012

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name

Date Filed

Judge

Drug

Patent No(s).

Avanir Pharma., Inc. v. Impax Labs., Inc., 12-1298 (D. Del.)

Oct. 8, 2012

Hon. Leonard P. Stark

Nuedexta®(dextromethorphan hydrobromide / quinidine sulfate capsules)

8,227,484

Purdue Pharma L.P. v. Sandoz Inc., 12-7582 (S.D.N.Y.)

Oct. 10, 2012

Hon. Sidney H. Stein

OxyContin®(oxycodone hydrochloride extended-release tablets)

8,114,383

Gilead Sciences, Inc. v. Lupin Ltd., 12-7910 (S.D.N.Y.)

Oct. 24, 2012

Hon. Richard J. Sullivan

Viread®(tenofovir disoproxil fumarate tablets)

5,922,695

5,935,946

5,977,089

6,043,230

Purdue Pharma. Products L.P. v. Par Pharma., Inc., 12-6738 (D.N.J.)

Oct. 25, 2012

Hon. Jose L. Linares

Intermezzo®(zolpidem tartrate sublingual tablets)

8,242,131

8,252,809

Purdue Pharma. Products L.P. v. Par Formulations Private Ltd., 12-6741 (D.N.J.)

Oct. 25, 2012

Hon. Jose L. Linares

Intermezzo®(zolpidem tartrate sublingual tablets)

8,242,131

8,252,809

Mallinckrodt Inc. v. Watson Labs., Inc.-Florda, 12-6744 (D.N.J.)

Oct. 25, 2012

Hon. William J. Martini

Exalgo®(hydromorphone hydrochloride extended-release tablets)

5,914,131

Jazz Pharma., Inc. v. Roxane Labs., Inc., 12-6761 (D.N.J.)

Oct. 26, 2012

Hon. Esther Salas

Xyrem®(sodium oxybate oral solution)

8,263,650

Acura Pharma., Inc. v. Impax Labs., Inc., 12-1371 (D. Del.)

Oct. 31, 2012

Hon. Richard G. Andrews

Oxecta®(oxycodone hydrochloride tablets)

7,510,726

Acura Pharma., Inc. v. Par Pharma., Inc., 12-1372 (D. Del.)

Oct. 31, 2012

Hon. Richard G. Andrews

Oxecta®(oxycodone hydrochloride tablets)

7,510,726

Acura Pharma., Inc. v. Sandoz Inc., 12-1373 (D. Del.)

Oct. 31, 2012

Hon. Richard G. Andrews

Oxecta®(oxycodone hydrochloride tablets)

7,510,726

Acura Pharma., Inc. v. Watson Labs., Inc.-Florda, 12-1374 (D. Del.)

Oct. 31, 2012

Hon. Richard G. Andrews

Oxecta®(oxycodone hydrochloride tablets)

7,510,726

Acura Pharma., Inc. v. Sandoz, Inc., 12-6784 (S.D.N.Y.)

Nov. 1, 2012

Hon. Michael A. Shipp

Oxecta®(oxycodone hydrochloride tablets)

7,510,726

AstraZeneca Pharma. LP v. Lupin Ltd., 12-6888 (D.N.J.)

Nov. 5, 2012

Hon. Joel A. Pisano

Seroquel XR®(quetiapine fumarate extended-release tablets)

5,948,437

Endo Pharma. Inc. v. Teva Pharma. USA, Inc., 12-8060 (S.D.N.Y.)

Nov. 5, 2012

Hon. George B. Daniels

Opana®ER (oxymorphone hydrochloride extended-release tablets)

7,851,482

8,075,872

8,114,383

8,192,722

8,309,060

8,309,122

Endo Pharma. Inc. v. Amneal Pharma., LLC, 12-8115 (S.D.N.Y.)

Nov. 7, 2012

Hon. Andrew L. Carter, Jr.

Opana®ER (oxymorphone hydrochloride extended-release tablets)

7,851,482

8,075,872

8,114,383

8,192,722

8,309,060

8,309,122

AbbVie Inc. v. Watson Pharma., Inc., 12-1409 (D. Del.)

Nov. 8, 2012

Hon. Sue L. Robinson

Niaspan®(niacin extended-release tablets)

6,080,428

6,469,035

Merck Sharp & Dohme Corp. v. APP Pharma., Inc., 12-1410 (D. Del.)

Nov. 9, 2012

Hon. Richard G. Andrews

Integrilin®(eptifibatide injection)

5,807,825

5,747,447

5,968,902

Ferring B.V. v. Watson Pharma., Inc., 12-1935 (D. Nev.)

Nov. 9, 2012

Hon. Miranda M. Du

Lysteda®(tranexamic acid tablets)

8,273,795

Ferring B.V. v. Apotex Inc., 12-1941 (D. Nev.)

Nov. 9, 2012

Hon. Gloria M. Navarro

Lysteda®(tranexamic acid tablets)

8,273,795

Endo Pharma. Inc. v. Impax Labs., Inc., 12-8317 (S.D.N.Y.)

Nov. 14, 2012

Hon. P. Kevin Castel

Opana®ER (oxymorphone hydrochloride extended-release tablets)

7,851,482

8,075,872

8,114,383

8,192,722

8,309,060

8,309,122

Endo Pharma. Inc. v. Sandoz, Inc., 12-8318 (S.D.N.Y.)

Nov. 14, 2012

JudgeP. Kevin Castel

Opana®ER (oxymorphone hydrochloride extended-release tablets)

7,851,482

8,075,872

8,114,383

8,192,722

8,309,060

8,309,122

Astellas US LLC v. Akorn, Inc., 12-1489 (D. Del.)

Nov. 19, 2012

Hon. Sue L. Robinson

Adenoscan®(adenosine injection)

5,731,296

Millenium Pharma., Inc. v. Accord Healthcare, Inc., 12-1490 (D. Del.)

Nov. 19, 2012

Hon. Gregory M. Sleet

Velcade®(bortezomib injection)

6,713,446

6,958,319

Apotex, Inc. v. Daiichi Sankyo, Inc., 12-9295 (N.D. Ill.)

Nov. 20, 2012

Hon. Sharon Johnson Coleman

Benicar®(olmesartan medoxomil tablets)

6,878,703

Bayer Pharma AG v. Lupin Ltd., 12-1592 (D. Del.)

Nov. 28, 2012

Hon. Christopher J. Burke

Natazia®(estradiol valerate / dinogest tablets)

8,071,577

Takeda Pharma. Co., Ltd. v. Lupin Ltd., 12-7333 (D.N.J.)

Nov. 29, 2012

Hon. Joel A. Pisano

Prevacid®SoluTab™ (lansoprazole delayed-release orally disintegrating tablets)

6,328,994

7,431,942

7,399,485

7,875,292

Bayer Pharma AG v. Lupin Ltd., 12-3526 (D. Md.)

Nov. 29, 2012

Hon. William D. Quarles, Jr.

Natazia®(estradiol valerate / dinogest tablets)

8,071,577

Medicis Pharma. Corp. v. Alkem Labs. Ltd., 12-1663 (D. Del.)

Dec. 5, 2012

Hon. Leonard P. Stark

Solodyn®(minocycline hydrochloride extended-release tablets)

5,908,838

7,790,705

8,268,804

Medicis Pharma. Corp. v. Sidmak Labs. (Indai) Pvt. Ltd., 12-1664 (D. Del.)

Dec. 5, 2012

Hon. Leonard P. Stark

Solodyn®(minocycline hydrochloride extended-release tablets)

5,908,838

7,790,705

8,268,804

Jazz Pharma., Inc. v. Roxane Labs., Inc., 12-7459 (D.N.J.)

Dec. 5, 2012

Hon. Esther Salas

Xyrem®(sodium oxybate oral solution)

8,324,275

Glycobiosciences, Inc. v. Anika Therapeutics, Inc., 12-1963 (D.D.C.)

Dec. 6, 2012

Hon. Rosemary M. Collyer

Hyalofill®(hyaluronic acid ester)

6,120,804

6,723,345

Medicis Pharma. Corp. v. Alkem Labs. Ltd., 12-7493 (D.N.J.)

Dec. 6, 2012

Hon. Michael A. Shipp

Solodyn®(minocycline hydrochloride extended-release tablets)

5,908,838

7,790,705

8,268,804

Osi Pharma., LLC v. Roxane Labs., Inc., 12-1669 (D. Del.)

Dec. 7, 2012

Hon. Sue L. Robinson

Tarceva®(erlotinib hydrochloride tablets)

RE41,065

6,900,221

7,087,613

Alkermes Pharma Ireland Ltd. v. Mylan Pharma. Inc., 12-1673 (D. Del.)

Dec. 7, 2012

Hon. Sue L. Robinson

Focalin®XR (dexmethylphenidate hydrochloride extended-release capsules)

6,228,398

6,730,325

Celgene Corp. v. Mylan Pharma. Inc., 12-7590 (D.N.J.)

Dec. 7, 2012

Hon. Susan D. Wigenton

Focalin XR®(dexmethylphenidate hydrochloride extended-release capsules)

5,908,850

6,355,656

6,528,530

5,837,284

6,635,284

7,431,944

Endo Pharma. Inc. v. Actavis Inc., 12-8985 (S.D.N.Y.)

Dec. 11, 2012

JudgeThomas P. Griesa

Opana®ER (oxymorphone hydrochloride extended-release tablets)

7,851,482

8,309,122

8,329,216

Astellas US LLC v. Fresenius Kabi USA, LLC, 12-1699 (D. Del.)

Dec. 12, 2012

Hon. Sue L. Robinson

Adenoscan®(adenosine injection)

5,731,296

Merz Pharma., LLC v. Par Pharma., Inc., 12-1723 (D. Del.)

Dec. 17, 2012

Hon. Sue L. Robinson

Cuvposa®(glycopyrrolate oral solution)

7,638,552

7,816,396

Bayer Pharma AG v. Watson Pharma., Inc., 12-1726 (D. Del.)

Dec. 18, 2012

Hon. Christopher J. Burke

Natazia®(estradiol valerate / dinogest tablets)

8,071,577

Endo Pharma. Inc. v. Par Pharma. Cos., Inc., 12-9261 (S.D.N.Y.)

Dec. 19, 2012

JudgeThomas P. Griesa

Opana®ER (oxymorphone hydrochloride extended-release tablets)

7,851,482

8,309,122

8,329,216

8,075,872

8,114,383

8,192,722

8,309,060

Millenium Pharma., Inc. v. Actavis, Inc., 12-1750 (D. Del.)

Dec. 21, 2012

Hon. Gregory M. Sleet

Velcade®(bortezomib injection)

6,713,446

6,958,319

UCB, Inc. v. Teva Pharma. USA, Inc., 12-4420 (N.D. Ga.)

Dec. 21, 2012

Hon. Charles A. Pannell, Jr.

Metadate CD®(methylphenidate hydrochloride capsules)

6,344,215

Bristol-Myers Squibb Co. v. Dr. Reddy’s Labs., Ltd., 12-7800 (D.N.J.)

Dec. 21, 2012

Hon. Michael A. Shipp

Ixempra®Kit (ixabepilone for injection)

6,670,384

7,022,330

RE41,393

Shionogi & Co., Ltd. v. Sandoz Inc., 12-7907 (D.N.J.)

Dec. 28, 2012

Hon. Freda L. Wolfson

Doribax®(doripenem for injection)

8,247,402

 

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