New ANDA Cases

Spring 2014

GENERICally Speaking
Case Name Date Filed Judge Drug Patent No(s).

Alcon Research, Ltd. v. Micro Labs Ltd., 14-0014 (D. Del.)

Jan. 9, 2014

Hon. Sue L. Robinson

Travatan Z® (travoprost ophthalmic solution)

8,268,299
8,323,630
8,388,941

Biodelivery Sciences International, Inc. v. RB Pharma. Ltd., IPR2014-00325 (PTAB)

Jan. 15, 2014

N/A

Suboxone® (buprenorphine hydrochloride / naloxone hydrochloride)

8,475,832

Amneal Pharma., LLC v. Endo Pharma., Inc., IPR2014-00360 (PTAB)

Jan. 16, 2014

N/A

Opana® ER (oxymorphone hydrochloride extended-release tablets)

8,329,216

Amneal Pharma., LLC v. Endo Pharma., Inc., IPR2014-00361 (PTAB)

Jan. 16, 2014

N/A

Opana® ER (oxymorphone hydrochloride extended-release tablets)

8,309,122

Takeda Pharma. Co., Ltd. v. Mylan Inc., 14-0314
(N.D. Cal.)

Jan. 21, 2014

Hon. Lucy H. Koh

Dexilant® (dexlansoprazole delayed-release capsules)

7,339,064

Lyne Labs., Inc. v. Lupin Ltd., 14-10153 (D. Mass.)

Jan. 21, 2014

Hon. Nathaniel M. Gorton

Phoslyra® (calcium acetate oral solution)

8,591,938
8,592,480

Lyne Labs., Inc. v. Par Pharma., Inc., 14-10154
(D. Mass.)

Jan. 21, 2014

Hon. Nathaniel M. Gorton

Phoslyra® (calcium acetate oral solution)

8,591,938
8,592,480

Millennium Pharma., Inc. v. Teva Pharma. USA, Inc., 14-0093 (D. Del.)

Jan. 22, 2014

Hon. Gregory M. Sleet

Velcade® (bortezomib injection)

6,713,446
6,958,319

Cadence Pharma., Inc. v. Wockhardt Ltd., 14-0094 (D. Del.)

Jan. 22, 2014

Hon. Leonard P. Stark

Ofirmev® (acetaminophen solution)

6,028,222
6,992,218

Eli Lilly and Co. v. Glenmark Generics Inc., USA, 14-0104 (S.D. Ind.)

Jan. 23, 2014

Hon. Tanya W. Pratt

Alimta® (pemetrexed disodium for injection)

7,772,209

Eli Lilly and Co. v. Par Pharma. Cos., Inc., 14-0109 (S.D. Ind.)

Jan. 23, 2014

Hon. Sarah E. Barker

Effient® (prasugrel hydrochloride tablets)

8,404,703
8,569,325

Cadence Pharma., Inc. v. Wockhardt Ltd., 14-0485 (D.N.J.)

Jan. 23, 2014

Hon. Renee M. Bumb

Ofirmev® (acetaminophen solution)

6,028,222
6,992,218

AbbVie Inc. v. Roxane Labs., Inc., 14-0085 (S.D. Ohio)

Jan. 23, 2014

Hon. Michael H. Watson

Norvir® (ritonavir tablets)

8,470,347

Eli Lilly and Co. v. Par Pharma. Cos., Inc., 14-0508 (D.N.J.)

Jan. 24, 2014

Hon. Claire C. Cecchi

Effient® (prasugrel hydrochloride tablets)

8,404,703
8,569,325

Alcon Research, Ltd. v. Cipla Ltd., 14-0131 (S.D. Ind.)

Jan. 29, 2014

Hon. Richard L. Young

Pataday® (olopatadine hydrochloride ophthalmic solution)

6,995,186
7,402,609

Novartis Pharma. Corp. v. Noven Pharma., Inc., 14-0111 (D. Del.)

Jan. 30, 2014

Hon. Richard G. Andrews

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

6,316,023
6,335,031

Sanofi-Aventis U.S. LLC v. Eli Lilly and Co., 14-0113
(D. Del.)

Jan. 30, 2014

Hon. Richard G. Andrews

Lantus® / Lantus® SoloSTAR® (insulin glargine [rDNA origin] for injection)

8,556,864
8,603,044
7,476,652
7,713,930

Teijin Ltd. v. Ranbaxy Labs., Ltd., 14-0117 (D. Del.)

Jan. 31, 2014

Hon. Sue L. Robinson

Uloric® (febuxostat tablets)

6,225,474

Forest Labs., Inc. v. Teva Pharma. USA, Inc., 14-0121 (D. Del.)

Jan. 31, 2014

Hon. Leonard P. Stark

Namenda XR® (memantine hydrochloride extended-release capsules)

5,061,703
8,039,009
8,168,209
8,173,708
8,283,379
8,329,752
8,362,085
8,598,233

Cephalon, Inc. v. Actavis LLC, 14-0122 (D. Del.)

Jan. 31, 2014

Hon. Gregory M. Sleet

Treanda® (bendamustine hydrochloride)

8,445,524
8,436,190

Senju Pharma. Co., Ltd. v. Lupin, Ltd., 14-0667 (D.N.J.)

Jan. 31, 2014

Hon. Jerome B. Simandle

Prolensa® (bromfenac ophthalmic solution 0.07%)

8,129,431

Novartis Pharma. Corp. v. Dr. Reddy’s Labs., Ltd., 14-0157 (D. Del.)

Feb. 5, 2014

Hon. Leonard P. Stark

Gleevec® (imatinib mesylate capsules)

6,894,051

Forest Labs., Inc. v. Glenmark Generics Inc., 14-0159
(D. Del.)

Feb. 6, 2014

Hon. Sue L. Robinson

Savella® (milnacipran hydrochloride tablets)

6,602,911
7,888,342
7,994,220

Fresenius Kabi USA, LLC v. Dr. Reddy’s Lab., Ltd.,
14-0160 (D. Del.)

Feb. 6, 2014

Hon. Sue L. Robinson

Diprivan® (propofol injectable emulsion)

8,476,010

Fresenius Kabi USA, LLC v. Watson Labs., Inc. 14-0161 (D. Del.)

Feb. 6, 2014

Hon. Sue L. Robinson

Diprivan® (propofol injectable emulsion)

8,476,010

Novartis Pharma. Corp. v. Dr. Reddy’s Labs., Ltd., 14-0785 (D.N.J.)

Feb. 6, 2014

Hon. Claire C. Cecchi

Gleevec® (imatinib mesylate capsules)

6,894,051

Teijin Ltd. v. Hetero USA, Inc., 14-0166 (D. Del.)

Feb. 7, 2014

Hon. Sue L. Robinson

Uloric® (febuxostat tablets)

6,225,474

Teijin Ltd. v. Lupin Ltd., 14-0184 (D. Del.)

Feb. 12, 2014

Hon. Sue L. Robinson

Uloric® (febuxostat tablets)

6,225,474

Teijin Ltd. v. Roxane Labs., Inc., 14-0189 (D. Del.)

Feb. 12, 2014

Hon. Sue L. Robinson

Uloric® (febuxostat tablets)

6,225,474

Merck Sharp & Dohme Corp. v. Xellia Pharma. APS, 14-0199 (D. Del.)

Feb. 14, 2014

Hon. Richard G. Andrews

Cancidas® (caspofungin acetate injection)

5,952,300

Forest Labs., Inc. v. Apotex Corp., 14-0200 (D. Del.)

Feb. 14, 2014

Hon. Leonard P. Stark

Namenda XR® (memantine hydrochloride extended-release capsules)

8,039,009
8,168,209
8,173,708
8,283,379
8,329,752
8,362,085
8,598,233

Salix Pharma., Inc. v. Novel Labs., Inc., 14-0213 (D. Del.)

Feb. 18, 2014

Hon. Gregory M. Sleet

Apriso® (mesalamine extended-release capsules)

6,551,620
8,337,886
8,496,965

Otsuka Pharma. Co., Ltd. v. Torrent Pharma. Ltd., 14-1078 (D.N.J.)

Feb. 18, 2014

Hon. Jerome B. Simandle

Abilify® (aripiprazole tablets)

8,017,615
8,580,796

Merck Sharp & Dohme Corp. v. Xellia Pharma. APS, 14-0124 (W.D. Wis.)

Feb. 18, 2014

Hon. Stephen L. Crocker

Cancidas® (caspofungin acetate injection)

5,952,300

AbbVie Inc. v. Aurobindo Pharma Ltd., 14-0215
(D. Del.)

Feb. 19, 2014

Hon. Gregory M. Sleet

Zemplar® (paricalcitol injection)

5,597,815
6,136,799
6,361,758

Meda Pharma. Inc. v. Perrigo Israel Pharma. Ltd., 14-1241 (D.N.J.)

Feb. 25, 2014

Hon. Joel A. Pisano

Astepro® (azelastine hydrochloride nasal spray)

8,518,919

Sanofi v. Glenmark Generics Inc., USA, 14-0264 (D. Del.)

Feb. 26, 2014

Hon. Richard G. Andrews

Multaq® (dronedarone tablets)

8,318,800
8,410,167
8,602,215

Sanofi v. Watson Labs., Inc., 14-0265 (D. Del.)

Feb. 26, 2014

Hon. Richard G. Andrews

Multaq® (dronedarone tablets)

8,318,800
8,410,167
8,602,215

Takeda Pharma. USA, Inc. v. Watson Labs., Inc., 14-0268 (D. Del.)

Feb. 27, 2014

Hon. Sue L. Robinson

Colcrys® (colchicine, USP)

7,601,758
7,619,004
7,820,681
7,915,269
7,964,647
7,964,648
7,981,938
8,093,296
8,093,297
8,097,655
8,415,395
8,415,396
8,440,721
8,440,722

Lyne Labs., Inc. v. Roxane Labs., Inc., 14-10460
(D. Mass.)

Feb. 27, 2014

Hon. Nathaniel M. Gorton

Phoslyra® (calcium acetate oral solution)

8,591,938
8,592,480

Antares Pharma, Inc. v. Medac Pharma, Inc., 14-0270 (D. Del.)

Feb. 28, 2014

Hon. Sue L. Robinson

OtrexupTM (methotrexate injection)

8,480,631
6,565,553

Bausch & Lomb Inc. v. Sandoz Inc., 14-1325
(D.N.J.)

Mar. 2, 2014

Hon. Noel L. Hillman

Bepreve® (bepotastine besilate 1.5% solution/drops)

6,780,877

Novartis Pharma. Corp. v. Pharmaceutics Int’l, Inc., 14-1347 (D.N.J.)

Mar. 3, 2014

Hon. Susan D. Wigenton

Zometa® (zoledronic acid injection)

8,324,189

Janssen Products, L.P. v. Lupin Ltd., 14-1370
(D.N.J.)

Mar. 4, 2014

Hon. William H. Walls

Prezista® (darunavir tablets)

8,518,987

Roxane Labs., Inc. v. Camber Pharma., Inc., 14-0232
(S.D. Ohio)

Mar. 4, 2014

Hon. Gregory L. Frost

calcium acetate capsules

8,563,032

Sanofi v. Alkem Labs. Ltd., 14-0292 (D. Del.)

Mar. 6, 2014

Hon. Richard G. Andrews

Multaq® (dronedarone tablets)

7,323,493
8,318,800
8,410,167
8,602,215

Sanofi v. First Time US Generics LLC, 14-0293
(D. Del.)

Mar. 6, 2014

Hon. Richard G. Andrews

Multaq® (dronedarone tablets)

8,318,800
8,410,167
8,602,215

Sanofi v. Sun Pharma Global FZE, 14-0294 (D. Del.)

Mar. 6, 2014

Hon. Richard G. Andrews

Multaq® (dronedarone tablets)

7,323,493
8,318,800
8,410,167
8,602,215

Allergan, Inc. v. Actavis PLC, 14-0188 (E.D. Tex.)

Mar. 6, 2014

Hon. Rodney Gilstrap

Restasis® (cyclosporine ophthalmic emulsion 0.05%)

8,629,111

Medac Pharma., Inc. v. Antares Pharma., Inc., 14-1498 (D.N.J.)

Mar. 7, 2014

Hon. Jerome B. Simandle

OtrexupTM (methotrexate injection)

8,664,231

Eli Lilly and Co. v. Accord Healthcare, Inc. USA, 14-0389 (S.D. Ind.)

Mar. 12, 2014

Hon. Sarah Evans Barker

Effient® (prasugrel hydrochloride tablets)

5,288,726
8,404,703
8,569,325

Eli Lilly and Co. v. Accord Healthcare, Inc. USA, 14-1643 (D.N.J.)

Mar. 13, 2014

Hon. Claire C. Cecchi

Effient® (prasugrel hydrochloride tablets)

5,288,726
8,404,703
8,569,325

Cephalon, Inc. v. Sun Pharma Global FZE, 14-0333 (D. Del.)

Mar. 14, 2014

Hon. Gregory M. Sleet

Treanda® (bendamustine hydrochloride)

8,609,863

Cephalon, Inc. v. Dr. Reddy’s Labs., Ltd., 14-0334 (D. Del.)

Mar. 14, 2014

Hon. Gregory M. Sleet

Treanda® (bendamustine hydrochloride)

8,609,863

Cephalon, Inc. v. Emcure Pharma Ltd., 14-0335
(D. Del.)

Mar. 14, 2014

Hon. Gregory M. Sleet

Treanda® (bendamustine hydrochloride)

8,445,524

Sanofi v. Sun Pharma Global FZE, 14-1844 (N.D. Ill.)

Mar. 14, 2014

Hon. Ruben Castillo

Multaq® (dronedarone tablets)

7,323,493
8,318,800
8,410,167
8,602,215

Astellas US LLC v. Emcure Pharma. USA, Inc., 14-1665 (D.N.J.)

Mar. 14, 2014

Hon. Stanley R. Chesler

Adenoscan® (adenosine injection)

5,731,296

Otsuka Pharma. Co., Ltd. v. Amneal Pharma., LLC, 14-1688 (D.N.J.)

Mar. 14, 2013

Hon. Mary L. Cooper

Abilify® (aripiprazole oral solution)

7,053,092

Pfizer Inc. v. Torrent Pharma. Ltd., 14-1704 (D.N.J.)

Mar. 17, 2014

Hon. Mary L. Cooper

Viagra® (sildenafil citrate tablets)

6,469,012

Cephalon, Inc. v. Emcure Pharma Ltd., 14-1705
(D. Del.)

Mar. 17, 2014

Hon. Peter G. Sheridan

Treanda® (bendamustine hydrochloride)

8,445,524

Pfizer Inc. v. Torrent Pharma. Ltd., 14-1831 (S.D.N.Y.)

Mar. 17, 2014

Hon. Paul A. Engelmayer

Viagra® (sildenafil citrate tablets)

6,469,012

Bristol-Myers Squibb Co. v. Apotex, Inc., 14-0351
(D. Del.)

Mar. 19, 2014

Hon. Richard G. Andrews

Baraclude® (entecavir tablets)

5,206,244

Sanofi v. Alkem Labs. Ltd., 14-1957 (N.D. Ill.)

Mar. 19, 2014

Hon. Ruben Castillo

Multaq® (dronedarone tablets)

7,323,493
8,318,800
8,410,167
8,602,215

UCB, Inc. v. Corepharma, L.L.C., 14-1788 (D.N.J.)

Mar. 20, 2014

Hon. Faith S. Hochberg

Metadate CD® (methylphenidate hydrochloride capsules)

6,344,215

ViiV Healthcare UK Ltd. v. Lupin Ltd., 14-0369 (D. Del.)

Mar. 21, 2014

Hon. Richard G. Andrews

Epzicom® (abacavir sulfate / lamivudine tablets)

6,417,191
6,294,540

Bayer Pharma AG v. Watson Labs., Inc., 14-1804 (D.N.J.)

Mar. 21, 2014

Hon. Jose L. Linares

Staxyn® (vardenafil hydrochloride tablets)

8,613,950

Novartis Pharma. Corp. v. Gland Pharma Ltd., 14-1841 (D.N.J.)

Mar. 21, 2014

Hon. Susan D. Wigenton

Reclast® (zoledronic acid injection)

8,052,987

Bausch & Lomb, Inc. v. Akorn, Inc., 14-1866 (D.N.J.)

Mar. 24, 2014

Hon. Noel L. Hillman

Bepreve® (bepotastine besilate ophthalmic solution)

6,780,877

Novartis Pharma. Corp. v. Dr. Reddy’s Labs., Ltd., 14-0387 (D. Del.)

Mar. 26, 2014

Hon. Leonard P. Stark

Gleevec® (imatinib mesylate capsules)

RE43,932

Mallinckrodt LLC v. Amneal Pharma. LLC, 14-0389
(D. Del.)

Mar. 27, 2014

Hon. Richard G. Andrews

Pennsaid® (diclofenac sodium topical solution)

8,217,078
8,546,450
8,618,164

Bausch & Lomb, Inc. v. Micro Labs. Ltd., 14-1974 (D.N.J.)

Mar. 28, 2014

Hon. Noel L. Hillman

Bepreve® (bepotastine besilate ophthalmic solution)

6,780,877

Bausch & Lomb, Inc. v. Apotex, Inc., 14-1975 (D.N.J.)

Mar. 28, 2014

Hon. Noel L. Hillman

Bepreve® (bepotastine besilate ophthalmic solution)

6,780,877

Otsuka Pharma. Co., Ltd. v. Wockhardt Bio AG, 14-1979 (D.N.J.)

Mar. 28, 2014

Hon. Jerome B. Simandle

Abilify® (aripiprazole tablets)

8,017,615
8,580,796

Supernus Pharma. Inc. v. Actavis, Inc., 14-1981 (D.N.J.)

Mar. 28, 2014

Hon. Renee M. Bumb

Oxtellar XR™ (oxcarbazepine extended-release tablets)

8,617,600


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