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New ANDA Cases
Winter 2013
![GENERICally Speaking: A Hatch Waxman Litigation Bulletin](/-/media/images/newsletters/generically-speaking-social-graphics/generically-speaking-nwsltr-badge.jpg?la=en&h=160&w=390&la=en&hash=314B8432ED62E0647D7FC4565EC18B79)
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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