New ANDA Cases

Fall 2013

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name

Date Filed

Judge

Drug

Patent
No(s).

Alpex Pharma., S.A. v. Zydus Pharma. USA, Inc., 13-4076 (D.N.J.)

July 1, 2013

Hon. Noel L. Hillman

Suprenza®(phentermine hydrochloride tablets)

6,149,938

Purdue Pharma L.P. v. Teva Pharma. USA, Inc., 13-4606 (S.D.N.Y.)

July 2, 2013

Hon. Sidney H. Stein

OxyContin®(oxycodone hydrochloride)

8,337,888

8,309,060

Novartis AG v. Accord Healthcare, Inc. USA, 13-1013 (D.D.C.)

July 3, 2013

Hon. Emmet G. Sullivan

Myfortic®(mycophenolate sodium delayed-release tablets)

6,025,391

6,172,107

6,306,900

Aptalis Pharma US Inc. v. Mylan Pharma., Inc., 13-4158 (D.N.J.)

July 5, 2013

Hon. Mary L. Cooper

Canasa®(mesalamine rectal suppository)

8,217,083

8,436,051

Apotex Corp. v. Alcon Research Ltd., IPR2013-00428 (PTAB)

July 5, 2013

N/A

Travatan Z®(travoprost ophthalmic solution)

8,268,299

Apotex Corp. v. Alcon Research Ltd., IPR2013-00429 (PTAB)

July 5, 2013

N/A

Travatan Z®(travoprost ophthalmic solution)

8,323,630

Apotex Corp. v. Alcon Research Ltd., IPR2013-00430 (PTAB)

July 5, 2013

N/A

Travatan Z®(travoprost ophthalmic solution)

8,388,941

Par Pharma., Inc. v. Takeda Pharma. Co., Ltd., 13-3151 (N.D. Cal.)

July 9, 2013

Hon. Elizabeth D. Laporte

Dexilant®(dexlansoprazole delayed-release capsules)

8,461,187

Brigham and Women’s Hospital, Inc. v. Perrigo Co., 13-11640 (D. Mass.)

July 9, 2013

Hon. Rya W. Zobel

Pepcid Complete®(famotidine / magnesium hydroxide / calcium carbonate tablets)

5,229,137

UCB, Inc. v. Accord Healthcare, Inc., 13-1206 (D. Del.)

July 10, 2013

Hon. Leonard P. Stark

Vimpat®(lacosamide tablets)

RE38,551

UCB, Inc. v. Alembic Pharma. Ltd., 13-1207 (D. Del.)

July 10, 2013

Hon. Leonard P. Stark

Vimpat®(lacosamide tablets)

RE38,551

UCB, Inc. v. Amneal Pharma, LLC, 13-1208 (D. Del.)

July 10, 2013

Hon. Leonard P. Stark

Vimpat®(lacosamide tablets)

RE38,551

UCB, Inc. v. Apotex Corp., 13-1209 (D. Del.)

July 10, 2013

Hon. Leonard P. Stark

Vimpat®(lacosamide tablets)

RE38,551

UCB, Inc. v. Aurobindo Pharma Ltd., 13-1210 (D. Del.)

July 10, 2013

Hon. Leonard P. Stark

Vimpat®(lacosamide tablets)

RE38,551

UCB, Inc. v. Breckenridge Pharma., Inc., 13-1211 (D. Del.)

July 10, 2013

Hon. Leonard P. Stark

Vimpat®(lacosamide tablets)

RE38,551

UCB, Inc. v. Glenmark Generics Inc., USA., 13-1212 (D. Del.)

July 10, 2013

Hon. Leonard P. Stark

Vimpat®(lacosamide tablets)

RE38,551

UCB, Inc. v. Hetero USA Inc., 13-1213 (D. Del.)

July 10, 2013

Hon. Leonard P. Stark

Vimpat®(lacosamide tablets)

RE38,551

UCB, Inc. v. Mylan Pharma. Inc., 13-1214 (D. Del.)

July 10, 2013

Hon. Leonard P. Stark

Vimpat®(lacosamide tablets)

RE38,551

UCB, Inc. v. Ranbaxy Labs. Ltd., 13-1215 (D. Del.)

July 10, 2013

Hon. Leonard P. Stark

Vimpat®(lacosamide tablets)

RE38,551

UCB, Inc. v. Sandoz, Inc., 13-1216 (D. Del.)

July 10, 2013

Hon. Leonard P. Stark

Vimpat®(lacosamide tablets)

RE38,551

UCB, Inc. v. Sciegen Pharma., Inc., 13-1217 (D. Del.)

July 10, 2013

Hon. Leonard P. Stark

Vimpat®(lacosamide tablets)

RE38,551

UCB, Inc. v. Sun Pharma Global FZE, 13-1218 (D. Del.)

July 10, 2013

Hon. Leonard P. Stark

Vimpat®(lacosamide tablets)

RE38,551

UCB, Inc. v. Watson Labs., Inc.--Florida, 13-1219 (D. Del.)

July 10, 2013

Hon. Leonard P. Stark

Vimpat®(lacosamide tablets)

RE38,551

UCB, Inc. v. Zydus Pharma (USA), Inc., 13-1220 (D. Del.)

July 10, 2013

Hon. Leonard P. Stark

Vimpat®(lacosamide tablets)

RE38,551

Alcon Pharma. Ltd. v. Lupin Ltd., 13-1230 (D. Del.)

July 12, 2013

Hon. Sue L. Robinson

Moxeza®(moxifloxacin hydrochloride ophthalmic solution)

8,450,311

Cumberland Pharma. Inc. v. Akorn, Inc., 13-1232 (D. Del.)

July 12, 2013

Hon. Leonard P. Stark

Acetadote®(acetylcysteine injection)

8,148,356

Aptalis Pharma US Inc. v. Sandoz Inc., 13-4290 (D.N.J.)

July 12, 2013

Hon. Mary L. Cooper

Canasa®(mesalamine rectal suppository)

8,217,083

8,436,051

Abbvie, Inc. v. Roxane Labs., Inc., 13-0708 (S.D. Ohio)

July 18, 2013

Hon. Edmund A. Sargus

Norvir®
(ritonavir tablets)

8,268,349

8,399,015

Merck & CIE v. Watson Labs., Inc., 13-1272 (D. Del.)

July 23, 2013

Hon. Richard G. Andrews

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

6,441,168

Merck & CIE v. Watson Labs., Inc., 13-1309 (D. Nev.)

July 23, 2013

Hon. James C. Mahan

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

6,441,168

Cornerstone Therapeutics Inc. v. Exela Pharma Sciences, LLC, 13-1275 (D. Del.)

July 24, 2013

Hon. Gregory M. Sleet

Cardene®(nicardipine hydrochloride premixed injection)

7,612,102

7,659,291

Eisai Co., Ltd. v. Glenmark Pharma., Ltd., 13-1279 (D. Del.)

July 24, 2013

Hon. Leonard P. Stark

Banzel®(rufinamide tablets)

6,740,669

7,750,028

8,076,362

Eisai Co., Ltd. v. Hetero Labs Ltd., 13-1280 (D. Del.)

July 24, 2013

Hon. Leonard P. Stark

Banzel®(rufinamide tablets)

6,740,669

7,750,028

8,076,362

Eisai Co., Ltd. v. Lupin Ltd., 13-1281 (D. Del.)

July 24, 2013

Hon. Leonard P. Stark

Banzel®(rufinamide tablets)

6,740,669

7,750,028

8,076,362

Eisai Co., Ltd. v. Mylan Pharma. Inc., 13-1282 (D. Del.)

July 24, 2013

Hon. Leonard P. Stark

Banzel®(rufinamide tablets)

6,740,669

7,750,028

8,076,362

Eisai Co., Ltd. v. Roxane Labs., Inc., 13-1284 (D. Del.)

July 24, 2013

Hon. Leonard P. Stark

Banzel®(rufinamide tablets)

6,740,669

7,750,028

8,076,362

Janssen Pharma., Inc. v. Actavis Elizabeth LLC, 13-4507 (D.N.J.)

July 25, 2013

Hon. Claire C. Cecchi

Nucynta®and Nucynta®ER (tapentadol hydrochloride extended-release tablets)

RE39,593

7,994,364

8,309,060

Alcon Research, Ltd. v. Mylan Pharma. Inc., 13-1332 (D. Del.)

July 26, 2013

Hon. Sue L. Robinson

Travatan Z®(travoprost ophthalmic solution)

8,268,299

8,323,630

8,388,941

Depomed, Inc. v. Banner Pharmacaps Inc., 13-4542 (D.N.J.)

July 26, 2013

Hon. Jose L. Linares

Zipsor®(diclofenac potassium capsules)

6,365,180

7,662,858

7,884,095

7,939,518

8,110,606

UCB, Inc. v. Sun Pharma Global FZE, 13-5514 (N.D. Ill.)

Aug. 1, 2013

Hon. Amy J. St. Eve

Vimpat®(lacosamide tablets)

RE38,551

Pfizer Inc. v. Wockhardt Bio AG, 13-1387 (D. Del.)

Aug. 2, 2013

Hon. Gregory M. Sleet

Toviaz®(fesoterodine fumarate extended-release tablets)

6,858,650

7,384,980

7,855,230

7,985,772

8,338,478

Novartis Pharma. Corp. v. Hospira, Inc., 13-4669 (D.N.J.)

Aug. 2, 2013

Hon. Susan D. Wigenton

Zometa®(zoledronic acid)

7,932,241

8,324,189

Supernus Pharma., Inc. v. Actavis Inc., 13-4740 (D.N.J.)

Aug. 7, 2013

Hon. Renee M. Bumb

Oxtellar XR®(oxcarbazepine extended-release tablets)

7,722,898

7,910,131

Depomed, Inc. v. Banner Pharmacaps Inc., 13-0653 (M.D.N.C.)

Aug. 9, 2013

Hon. James A. Beaty, Jr.

Zipsor®(diclofenac potassium capsules)

6,365,180

7,662,858

7,884,095

7,939,518

8,110,606

AstraZeneca AB v. Wockhardt Ltd., 13-4854 (D.N.J.)

Aug. 12, 2013

Hon. Joel A. Pisano

Nexium®(esomeprazole magnesium delayed-release oral capsules)

5,714,504

5,877,192

6,875,872

Novo Nordisk Inc. v. Amneal Pharma., LLC, 13-4915 (D.N.J.)

Aug. 14, 2013

Hon. Michael A. Shipp

Vagifem®(estradiol vaginal tablets)

7,018,992

Teva Branded Pharma. Products R&D, Inc. v. Perrigo Pharma. Co., 13-1441 (D. Del.)

Aug. 16, 2013

Hon. Gregory M. Sleet

ProAir®HFA (albuterol sulfate inhalation aerosol)

7,105,152

7,566,445

6,446,627

8,132,712

Reckitt Benckiser Pharma., Inc. v. Par Pharma., Inc., 13-1461 (D. Del.)

Aug. 20, 2013

Hon. Richard G. Andrews

Suboxone®(buprenorphine hydrochloride / naloxone hydrochloride sublingual film)

8,475,832

8,017,150

Purdue Pharma. Products L.P. v. TWI Pharma, Inc., 13-5003 (D.N.J.)

Aug. 20, 2013

Hon. Jose L. Linares

Intermezzo®(zolpidem tartrate sublingual tablets)

8,242,131

8,252,809

Novartis Pharma. Corp. v. Par Pharma., Inc., 13-1467 (D. Del.)

Aug. 22, 2013

Hon. Richard G. Andrews

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

6,335,031

Purdue Pharma. Products L.P. v. TWI Pharma, Inc., 13-5999 (N.D. Ill.)

Aug. 22, 2013

Hon. Thomas M. Durkin

Intermezzo®(zolpidem tartrate sublingual tablets)

8,242,131

8,252,809

Intelgenx Corp. v. Wockhardt Bio, AG, 13-5074 (D.N.J.)

Aug. 23, 2013

Hon. William J. Martini

Forfivo XL®(bupropion hydrochloride extended-release tablets)

7,674,479

Horizon Pharma AG v. Watson Labs., Inc.—Florida, 13-5124 (D.N.J.)

Aug. 26, 2013

Hon. Joseph E. Irenas

Rayos®(prednisone delayed-release tablets)

6,488,960

6,677,326

8,309,124

8,168,218

8,394,407

Novartis Pharma. Corp. v. Akorn, Inc., 13-5125

Aug. 26, 2013

Hon. Susan D. Wigenton

Zometa®(zoledronic acid for injection)

Reclast® (zoledronic acid for injection)

7,932,241

9,052,987

8,324,189

Horizon Pharma AG v. Watson Labs., Inc.—Florida, 13-61868 (S.D. Fl.)

Aug. 28, 2013

Hon. Robert N. Scola, Jr.

Rayos®(prednisone delayed-release tablets)

6,488,960

6,677,326

8,309,124

8,168,218

8,394,407

Takeda Pharma. Co., Ltd. v. Mylan, Inc., 13-4001 (N.D. Cal.)

Aug. 28, 2013

Hon. Nathanael M. Cousins

Dexilant®(dexlansoprazole capsules)

8,173,158

8,173,187

Takeda Pharma. Co., Ltd. v. Mylan, Inc., 13-4002 (N.D. Cal.)

Aug. 28, 2013

Hon. Nathanael M. Cousins

Dexilant®(dexlansoprazole capsules)

6,462,058

6,664,276

6,939,971

7,285,668

7,790,755

Senju Pharma. Co., Ltd. v. Akorn, Inc., 13-6080 (S.D.N.Y.)

Aug. 28, 2013

Hon. Paul A. Crotty

Istalol®
(timolol maleate ophthalmic solution)

6,335,335

 

Genzyme Corp. v. Dr. Reddy’s Labs., Ltd., 13-1506 (D. Del.)

Aug. 29, 2013

Hon. Gregory M. Sleet

Mozobil®(plerixafor solution for injection)

RE42,152

7,897,590

6,987,102

Genzyme Corp. v. Sandoz, Inc., 13-1507 (D. Del.)

Aug. 29, 2013

Hon. Gregory M. Sleet

Mozobil®(plerixafor solution for injection)

RE42,152

7,897,590

6,987,102

Genzyme Corp. v. Teva Pharma. USA, Inc., 13-1508 (D. Del.)

Aug. 29, 2013

Hon. Gregory M. Sleet

Mozobil®(plerixafor solution for injection)

RE42,152

7,897,590

6,987,102

Takeda Pharma. Co., Ltd. v. Mylan, Inc., 13-0197 (N.D.W.V.)

Aug. 29, 2013

Hon. Irene M. Keeley

Dexilant®(dexlansoprazole capsules)

6,462,058

6,664,276

6,939,971

7,285,668

7,790,755

8,173,158

8,173,187

Takeda Pharma. USA, Inc. v. Par Pharma. Companies, Inc., 13-1524 (D. Del.)

Aug. 30, 2013

Hon. Sue L. Robinson

Colcrys®(colchicine tablets)

7,906,519

7,935,731

8,093,298

7,964,648

8,093,297

Roche Palo Alto LLC v. Mylan Pharma. Inc., 13-1532 (D. Del.)

Sept. 4, 2013

Hon. Gregory M. Sleet

Valcyte®(valganciclovir hydrochloride tablets)

6,083,953

Roche Palo Alto LLC v. Watson Labs., Inc.—Florida, 13-1533 (D. Del.)

Sept. 4, 2013

Hon. Gregory M. Sleet

Valcyte®(valganciclovir hydrochloride tablets)

6,083,953

Ferring B.V. v. Actavis, Inc., 13-0477 (D. Nev.)

Sept. 6, 2013

Hon. Larry R. Hicks

Lysteda®(tranexamic acid tablets)

8,487,005

7,947,739

8,022,106

8,273,795

Alkem Labs. Ltd. v. NPS Pharma., Inc., 13-6487 (N.D. Ill.)

Sept. 10, 2013

Hon. Edmond E. Chang

Nucynta ER®(tapentadol extended-release tablets)

6,071,970

Merck, Sharp & Dohme Corp. v. Aurobindo Pharma Ltd., 13-5442 (D.N.J.)

Sept. 11, 2013

Hon. Jerome B. Simandle

Sustiva®(efavirenz tablets)

6,639,071

6,939,964

6,673,372

Jazz Pharma., Inc. v. Amneal Pharma., LLC, 13-5450 (D.N.J.)

Sept. 12, 2013

Hon. Esther Salas

Xyrem®
(sodium oxybate oral solution)

8,457,988

8,461,203

Alcon Research, Ltd. v. Wockhardt Ltd., 13-1452 (S.D. Ind.)

Sept. 12, 2013

Hon. Sarah Evans Barker

Pataday®(olopatadine hydrochloride ophthalmic solution)

6,995,186

7,402,609

AbbVie Inc. v. Hikma Pharma. Co., Ltd., 13-1557 (D. Del.)

Sept. 13, 2013

Hon. Gregory M. Sleet

Zemplar®(paricalcitol injectable)

5,597,815

Eli Lilly and Co. v. Sun Pharma Indus. Ltd., 13-1469 (S.D. Ind.)

Sept. 13, 2013

Hon. Tonya Walton Pratt

Alimta®(pemetrexed injectable)

7,772,209

Senju Pharma Co., Ltd. v. Sandoz Inc., 13-6608 (S.D.N.Y.)

Sept. 18, 2013

Hon. Paul A. Crotty

Istalol®
(timolol maleate ophthalmic solution)

6,335,335

6,645,963

Forest Labs., Inc. v. Apotex Corp., 13-1602 (D. Del.)

Sept. 23, 2013

Hon. Sue L. Robinson

Savella®(milnacipran hydrochloride tablets)

6,602,911

7,888,342

7,994,220

Forest Labs., Inc. v. Hetero USA Inc., 13-1603 (D. Del.)

Sept. 23, 2013

Hon. Sue L. Robinson

Savella®(milnacipran hydrochloride tablets)

6,602,911

7,888,342

7,994,220

Forest Labs., Inc. v. Lupin Ltd., 13-1604 (D. Del.)

Sept. 23, 2013

Hon. Sue L. Robinson

Savella®(milnacipran hydrochloride tablets)

6,602,911

7,888,342

7,994,220

Forest Labs., Inc. v. Mylan Inc., 13-1605 (D. Del.)

Sept. 23, 2013

Hon. Sue L. Robinson

Savella®(milnacipran hydrochloride tablets)

6,602,911

7,888,342

7,994,220

Forest Labs., Inc. v. Par Pharma. Inc., 13-1606 (D. Del.)

Sept. 23, 2013

Hon. Sue L. Robinson

Savella®(milnacipran hydrochloride tablets)

6,602,911

7,888,342

7,994,220

Forest Labs., Inc. v. Ranbaxy Inc., 13-1607 (D. Del.)

Sept. 23, 2013

Hon. Sue L. Robinson

Savella®(milnacipran hydrochloride tablets)

6,602,911

7,888,342

7,994,220

Pfizer Inc. v. Apotex Inc., 13-6962 (N.D. Ill.)

Sept. 27, 2013

Hon. Marvin E. Aspen

Tygacil®(tigecycline injectable IV infusion)

8,372,995

Otsuka Pharma. Co., Ltd. v. Sandoz, Inc. 13-5788 (D.N.J.)

Sept. 27, 2013

Hon. Freda L. Wolfson

Busulfex®(busulfan injection)

5,430,057

5,559,148

Galderma Labs., L.P. v. Perrigo Israel Pharma. Ltd., 13-3930 (N.D. Tex.)

Sept. 27, 2013

Hon. David C Godbey

Epiduo®Gel (adapalene / benzoyl peroxide)

7,820,186

7,964,202

8,071,644

8,080,537

8,105,618

8,129,362

8,241,649

8,445,543

Helsinn Healthcare, S.A. v. Dr. Reddy’s Labs., Ltd., 13-5815 (D.N.J.)

Sept. 30, 2013

Hon. Mary L. Cooper

Aloxi®(palonosetron hydrochloride injection)

8,518,981


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