New ANDA Cases

Winter 2013

GENERICally Speaking

Case Name

Date Filed

Judge

Drug

Patent No(s).

Forest Labs., Inc. v. First Time US Generics LLC, 13-1642 (D. Del.)

Oct. 2, 2013

Hon. Sue L. Robinson

Savella®(milnacipran hydrochloride tablets)

6,602,911

7,888,342

7,994,220

Ferring B.V. v. Mylan Inc., 13-5909 (E.D. Pa)

Oct. 7, 2013

Hon. Norma L. Shapiro

Lysteda®(tranexamic acid tablets)

7,947,739

8,022,106

8,273,795

8,487,005

Reckitt Benckiser Pharma., Inc. v. Watson Labs., Inc., 13-1674 (D. Del.)

Oct. 8, 2013

Hon. Richard G. Andrews

Suboxone®(buprenorphine hydrochloride / naloxone hydrochloride sublingual film)

8,475,832

8,017,150

Cubist Pharma., Inc. v. Strides, Inc., 13-1679 (D. Del.)

Oct. 9, 2013

Hon. Gregory M. Sleet

Cubicin®(daptomycin for injection)

6,468,967

6,852,689

8,058,238

8,129,342

Cubist Pharma., Inc. v. Strides, Inc., 13-6016 (D.N.J.)

Oct. 9, 2013

Hon. Noel L. Hillman

Cubicin®(daptomycin for injection)

6,468,967

6,852,689

8,058,238

8,129,342

Baxter Healthcare Corp. v. HQ Specialty Pharma Corp., 13-13-6228 (D.N.J.)

Oct. 18, 2013

Hon. Faith S. Hochberg

Brevibloc®(esmolol hydrochloride in sodium chloride for injection)

6,310,094

6,528,540

Takeda Pharma. USA, Inc. v. Amneal Pharma., LLC, 13-1729 (D. Del.)

Oct. 21, 2013

Hon. Sue L. Robinson

Colcrys®(colchicine, USP)

7,906,519

7,935,731

8,093,298

7,964,648

8,093,297

Forest Labs., Inc. v. Amneal Pharma., LLC, 13-1737 (D. Del.)

Oct. 21, 2013

Hon. Sue L. Robinson

Savella®(milnacipran hydrochloride tablets)

6,602,911

7,888,342

7,994,220

Cephalon, Inc. v. Eagle Pharma., Inc., 13-1738 (D. Del.)

Oct. 21, 2013

Hon. Gregory M. Sleet

Treanda®(bendamustine hydrochloride)

8,445,524

Horizon Pharma AG v. Par Pharma. Cos., Inc., 13-6298 (D.N.J.)

Oct. 22, 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

AstraZeneca AB v. Dr. Reddy’s Labs. Inc., 13-6157 (D.N.J.)

Oct. 23, 2013

Hon. Joel A. Pisano

Vimovo®(naproxen / esomeprazole magnesium delayed-release tablets)

8,557,285

AstraZeneca AB v. Lupin Ltd., 13-6315 (D.N.J.)

Oct. 23, 2013

Hon. Joel A. Pisano

Vimovo®(naproxen / esomeprazole magnesium delayed-release tablets)

8,557,285

AstraZeneca AB v. Mylan Pharma., 13-6316 (D.N.J.)

Oct. 23, 2013

Hon. Joel A. Pisano

Vimovo®(naproxen / esomeprazole magnesium delayed-release tablets)

8,557,285

AstraZeneca AB v. Watson Labs., Inc.-Florida, 13-6318 (D.N.J.)

Oct. 23, 2013

Hon. Joel A. Pisano

Vimovo®(naproxen / esomeprazole magnesium delayed-release tablets)

8,557,285

Warner Chilcott Co., LLC v. Impax Labs., Inc., 13-6403 (D.N.J.)

Oct. 23, 2013

Hon. Faith S. Hochberg

Atelvia®(risedronate sodium delayed-release tablets)

7,645,459

7,645,460

8,246,989

Dow Pharma. Sciences, Inc. v. Actavis, Inc., 13-6401 (D.N.J.)

Oct. 24, 2013

Hon. Stanley R. Chesler

Acanya®(clindamycin phosphate / benzoyl peroxide gel)

8,288,434

Takeda Pharma. Co. Ltd. v. Wockhardt Bio AG, 13-6427 (D.N.J.)

Oct. 25, 2013

Hon. Joel A. Pisano

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

6,328,994

7,431,942

7,399,485

7,875,292

Ferring B.V. v. Apotex Inc., 13-0595 (D. Nev.)

Oct. 25, 2013

Hon. Larry R. Hicks

Lysteda®(tranexamic acid tablets)

8,487,005

Reckitt Benckiser Pharma., Inc. v. BioDelivery Sciences Int’l Inc., 13-0760 (E.D.N.C.)

Oct. 29, 2013

Hon. Terrence W. Boyle

Suboxone®(buprenorphine hydrochloride / naloxone hydrochloride sublingual film)

8,475,832

Cipher Pharma., Inc. v. Watson Labs., Inc.--Florida, 13-6502 (D.N.J.)

Oct. 29, 2013

Hon. Kevin McNulty

Absorica®(isotretinoin capsules)

8,367,102

Warner Chilcott Co., LLC v. Mylan, Inc., 13-6560 (N.J.D.)

Oct. 30, 2013

Hon. Joel A. Pisano

Lo Loestrin®Fe (norethindrone acetate / ethinyl estradiol tablets, ethinyl estradiol tablets, and ferrous fumarate tablets)

7,704,984

Teijin Ltd. v. Dr. Reddy’s Labs., Ltd., 13-1780 (D. Del.)

Oct. 30, 2013

Hon. Sue L. Robinson

Uloric®(febuxostat tablets)

6,225,474

Teijin Ltd. v. Mylan Pharma. Inc., 13-1781 (D. Del.)

Oct. 30, 2013

Hon. Sue L. Robinson

Uloric®(febuxostat tablets)

6,225,474

Otsuka Pharma. Co., Ltd. v. Wockhardt Ltd., 13-6604 (D.N.J.)

Oct. 31, 2013

Hon. Mary L. Cooper

Abilify®(aripiprazole oral solution)

6,977,257

Apotex Inc. v. Wyeth LLC, IPR2014-00115 (PTAB)

Nov. 1, 2013

N/A

Tygacil®(tigecycline injection)

7,879,828

Purdue Pharma L.P. v. Sandoz Inc., 13-7776 (S.D.N.Y.)

Nov. 1, 2013

Hon. Sidney H. Stein

OxyContin®(oxycodone hydrochloride extended-release tablets)

8,337,888

8,309,060

Forest Labs., Inc. v. Sandoz Inc., 13-1830 (D. Del.)

Nov. 4, 2013

Hon. Sue L. Robinson

Savella®(milnacipran hydrochloride tablets)

6,602,911

7,888,342

7,994,220

Teijin Ltd. v. Apotex Inc., 13-1851 (D. Del.)

Nov. 6, 2013

Hon. Sue L. Robinson

Uloric®(febuxostat tablets)

6,225,474

Teijin Ltd. v. Sun Pharma Global FZE, 13-1852 (D. Del.)

Nov. 6, 2013

Hon. Sue L. Robinson

Uloric®(febuxostat tablets)

6,225,474

Millenium Pharma., Inc. v. Apotex Corp., 13-1874 (D. Del.)

Nov. 8, 2013

Hon. Gregory M. Sleet

Velcade®(bortezomib injection)

6,713,446

6,958,319

Genzyme Corp. v. Dr. Reddy’s Labs., Inc., 13-6827 (D.N.J.)

Nov. 8, 2013

Hon. Joseph E. Irenas

Clolar®(clofarabine injection)

5,661,136

Novartis Pharma. Corp. v. Akorn, Inc., 13-6835 (D.N.J.)

Nov. 8, 2013

Hon. Susan D. Wigenton

Zometa®(zoledronic acid injection)

7,932,241

8,324,189

Eli Lilly and Co. v. Watson Labs., Inc., 13-1799 (S.D. Ind.)

Nov. 12, 2013

Hon. Jane Magnus-Stinson

Axiron®(testosterone topical solution)

6,299,900

6,818,226

6,923,983

8,071,075

8,419,307

8,435,944

Pfizer Inc. v. Fresenius Kabi USA, LLC, 13-1893 (D. Del.)

Nov. 13, 2013

Hon. Sue L. Robinson

Tygacil®(tigecycline injection)

RE40,183

7,879,828

8,372,995

Eli Lilly and Co. v. Watson Labs., Inc., 13-0637 (D. Nev.)

Nov. 14, 2013

Hon. William G. Cobb

Axiron®(testosterone topical solution)

6,299,900

6,818,226

6,923,983

8,071,075

8,419,307

8,435,944

Janssen Pharma., Inc. v. Sandoz Inc., 13-6929 (D.N.J.)

Nov. 14, 2013

Hon. Claire C. Cecchi

Nucynta®(tapentadol hydrochloride tablets)

RE39,593

7,994,364

Janssen Pharma., Inc. v. Roxane Labs., Inc., 13-0639 (D. Nev.)

Nov. 15, 2013

Hon. Miranda M. Du

Nucynta®(tapentadol hydrochloride tablets)

RE39,593

7,994,364

Millenium Pharma., Inc. v. Apotex Corp., 13-8240 (N.D. Ill.)

Nov. 15, 2013

Hon. Milton I. Shadur

Velcade®(bortezomib injection)

6,713,446

6,958,319

Dow Pharma. Sciences, Inc. v. Perrigo Co., 13-6922 (D.N.J.)

Nov. 15, 2013

Hon. Stanley R. Chesler

Acanya®(clindamycin phosphate / benzoyl peroxide gel)

8,288,434

Amneal Pharma., LLC v. Endo Pharma. Inc., IPR2014-00160 (PTAB)

Nov. 18, 2013

N/A

Opana®ER (oxymorphone hydrochloride extended-release tablets)

7,851,482

Teijin Ltd. v. Alembic Pharma. Ltd., 13-1939 (D. Del.)

Nov. 19, 2013

Hon. Sue L. Robinson

Uloric®(febuxostat tablets)

6,225,474

Shire LLC v. Apotex, Inc., 13-1965 (D. Del.)

Nov. 21, 2013

Hon. Richard G. Andrews

Intuniv®(guanfacine hydrochloride extended-release tablets)

6,287,599

6,811,794

Shire LLC v. Apotex, Inc., 13-24236 (S.D. Fla.)

Nov. 21, 2013

Hon. Jose E. Martinez

Intuniv®(guanfacine hydrochloride extended-release tablets)

6,287,599

6,811,794

Novartis Pharma. Corp. v. Roxane Labs., Inc., 13-1973 (D. Del.)

Nov. 25, 2013

Hon. Gregory M. Sleet

Fanapt®(iloperidone tablets)

RE39,198

Otsuka Pharma. Co., Ltd. v. Par Pharma., Inc., 13-1979 (D. Del.)

Nov. 26, 2013

Hon. Richard G. Andrews

Samsca®(tolvaptan tablets)

5,753,677

8,501,730

Novartis Pharma. Corp. v. Accord Healthcare Inc., 13-7178 (D.N.J.)

Nov. 26, 2013

Hon. Susan D. Wigenton

Zometa®(zoledronic acid injection)

8,324,189

Novartis Pharma. Corp. v. Roxane Labs., Inc., 13-7184 (D.N.J.)

Nov. 27, 2013

Hon. Noel L. Hillman

Fanapt®(iloperidone tablets)

RE39,198

Janssen Products, L.P. v. Teva Pharma. USA, Inc., 13-7576 (D.N.J.)

Nov. 27, 2013

Hon. William H. Walls

Prezista®(darunavir tablets)

8,518,987

Idenix Pharma., Inc. v. Gilead Sciences, Inc., 13-1987 (D. Del.)

Dec. 1, 2013

Hon. Leonard P. Stark

Sovaldi®(sofosbuvir tablets)

7,608,600

Idenix Pharma., Inc. v. Gilead Sciences, Inc., 13-13052 (D. Mass.)

Dec. 1, 2013

Hon. Leo T. Sorokin

Sovaldi®(sofosbuvir tablets)

6,914,054

7,608,597

AstraZeneca AB v. Aurobindo Pharma Ltd., 13-7298 (D.N.J.)

Dec. 3, 2013

Hon. Joel A. Pisano

Nexium®(esomeprazole magnesium delayed-release tablets)

5,714,504

6,369,085

7,411,070

8,466,175

AstraZeneca AB v. Kremers Urban Pharma., 13-7299 (D.N.J.)

Dec. 3, 2013

Hon. Joel A. Pisano

Nexium®(esomeprazole magnesium delayed-release tablets)

5,714,504

6,369,085

7,411,070

8,466,175

Endo Pharma., Inc. v. Ranbaxy Labs., Ltd., 13-8597 (S.D.N.Y.)

Dec. 3, 2013

Hon. Thomas P. Griesa

Opana®ER (oxymorphone hydrochloride extended-release tablets)

7,851,482

8,309,122

8,329,216

Teva Pharma. USA, Inc. v. Forest Labs., Inc., 13-2002 (D. Del.)

Dec. 5, 2013

Hon. Gregory M. Sleet

Namenda XR®(memantine extended-release capsules)

6,194,000

Reckitt Benckiser Pharma., Inc. v. Alvogen Pine Brook, Inc., 13-2003 (D. Del.)

Dec. 6, 2013

Hon. Richard G. Andrews

Suboxone®(buprenorphine hydrochloride / naloxone hydrochloride sublingual film)

8,475,832

8,017,150

Pfizer Inc. v. Hetero USA Inc., 13-2021 (D. Del.)

Dec. 11, 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

Pfizer Inc. v. Apotex Inc., 13-2022 (D. Del.)

Dec. 11, 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

Warner Chilcott Co., LLC v. Torrent Pharma. Ltd., 13-2039 (D. Del.)

Dec. 18, 2013

Hon. Gregory M. Sleet

Enablex®(darifenacin hydrobromide extended-release tablets)

6,106,864

Alcon Research, Ltd. v. Wockhardt Ltd., 13-2040 (D. Del.)

Dec. 19, 2013

Hon. Sue L. Robinson

Travatan Z®(travoprost ophthalmic solution)

8,268,299

8,323,630

8,388,941

IGI Labs., Inc. v. Mallinckrodt, LLC, 13-2044 (D. Del.)

Dec. 19, 2013

Hon. Richard G. Andrews

Pennsaid®(diclofenac sodium topical solution 1.5%)

8,217,078

8,546,450

Cephalon, Inc. v. Hetero Labs. Ltd., 13-2046 (D. Del.)

Dec. 19, 2013

Hon. Gregory M. Sleet

Treanda®(bendamustine hydrochloride)

8,445,524

Cephalon, Inc. v. Agila Specialties, Inc., 13-2080 (D. Del.)

Dec. 20, 2013

Hon. Gregory M. Sleet

Treanda®(bendamustine hydrochloride)

8,445,524

8,436,190

Cephalon, Inc. v. Innopharma, Inc., 13-2081 (D. Del.)

Dec. 20, 2013

Hon. Gregory M. Sleet

Treanda®(bendamustine hydrochloride)

8,445,524

8,436,190

Cephalon, Inc. v. Dr. Reddy’s Labs., Ltd., 13-2082 (D. Del.)

Dec. 20, 2013

Hon. Gregory M. Sleet

Treanda®(bendamustine hydrochloride)

8,445,524

8,436,190

Janssen Pharma., Inc. v. Aklem Labs., Ltd., 13-7803 (D.N.J.)

Dec. 23, 2013

Hon. Claire C. Cecchi

Nucynta®ER (tapentadol hydrochloride extended-release tablets)

8,536,130

Teijin Ltd. v. Zydus Pharma. USA, Inc., 13-2086 (D. Del.)

Dec. 23, 2013

Hon. Sue L. Robinson

Uloric®(febuxostat tablets)

7,361,676

Merck Sharp & Dohme B.V. v. Warner Chilcott Co., LLC, 13-2088 (D. Del.)

Dec. 24, 2013

Hon. Gregory M. Sleet

NuvaRing®(ethinyl estradiol / etonogestrel vaginal ring)

5,989,581

Cephalon, Inc. v, 13-Glenmark Pharma., Ltd., 13-2093 (D. Del.)

Dec. 26, 2013

Hon. Gregory M. Sleet

Treanda®(bendamustine hydrochloride)

8,445,524

Cephalon, Inc. v, 13-Hospira, Inc., 13-2094 (D. Del.)

Dec. 26, 2013

Hon. Gregory M. Sleet

Treanda®(bendamustine hydrochloride)

8,436,190

8,445,524

Cephalon, Inc. v, 13-Accord Healthcare, Inc., 13-2095 (D. Del.)

Dec. 26, 2013

Hon. Gregory M. Sleet

Treanda®(bendamustine hydrochloride)

8,436,190

8,445,524

Cephalon, Inc. v, 13-Sun Pharma Global FZE, 13-2096 (D. Del.)

Dec. 26, 2013

Hon. Gregory M. Sleet

Treanda®(bendamustine hydrochloride)

8,436,190

8,445,524

Janssen Pharma., Inc. v. Aklem Labs., Ltd., 13-9227 (N.D. Ill.)

Dec. 26, 2013

Hon. James F. Holderman

Nucynta®ER (tapentadol hydrochloride extended-release tablets)

8,536,130

Helsinn Healthcare S.A. v. Accord Healthcare, Inc., 13-2101 (D. Del.)

Dec. 27, 2013

Hon. Gregory M. Sleet

Aloxi®(palonosetron hydrochloride injection)

8,598,218

8,598,219

Jazz Pharma., Inc. v. Par Pharma., Inc., 13-7884 (D.N.J.)

Dec. 27, 2013

Hon. Esther Salas

Xyrem®(sodium oxybate oral solution)

6,472,431

6,780,889

7,262,219

7,851,506

8,263,650

8,324,275

8,461,203

7,668,730

7,765,106

7,765,107

7,895,059

8,457,988

8,589,182

Novartis Pharma. Corp. v. Fresenius Kabi USA, LLC, 13-7914 (D.N.J.)

Dec. 27, 2013

Hon. Susan D. Wigenton

Zometa®(zoledronic acid injection)

8,324,189

Cephalon, Inc. v. Sandoz Inc., 13-2104 (D. Del.)

Dec. 31, 2013

Hon. Gregory M. Sleet

Treanda®(bendamustine hydrochloride)

8,436,190

8,445,524


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