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


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