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

 

Related Publications

Fourth Quarter
GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
Oren Langer, Christopher Pinahs, Emily Tremblay, and Christine May
December 29, 2023
Corcept Therapeutics, Inc. v. Teva Pharms. USA, Inc.
GENERICally Speaking Hatch Waxman Bulletin
December 13, 2023
Acadia Pharms. Inc. v. Aurobindo Pharma Ltd.
GENERICally Speaking Hatch Waxman Bulletin
December 7, 2023
H. Lundbeck A/S v. Lupin Ltd.
GENERICally Speaking Hatch Waxman Bulletin
November 7, 2023
Eisai R&D Mgmt. Co., Ltd. v. Dr Reddy’s Labs., Inc.
GENERICally Speaking Hatch Waxman Bulletin
Back to Top