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28 Aug 2011, 9:57 pm by Patent Docs
Apotex Inc. et al. 4:11-cv-00600; filed August 25, 2011 in the Northern District of Texas • Plaintiffs: Alcon Pharmaceuticals, Ltd.; Alcon Research, Ltd. [read post]
27 Aug 2011, 7:55 pm
Creating a bioequivalent of Miacalin® would allow approval of the new pharmaceutical liquid dosage form as an ANDA under 21 U.S.C. [read post]
11 Aug 2011, 5:25 pm by FDABlog HPM
  As we previously reported, the statutory counterclaims provisions were recently asserted in the context of a 505(b)(2) application for Intelliject, Inc. [read post]
8 Aug 2011, 5:18 pm by FDABlog HPM
Karst –       FDA’s recent approval of ANDA No. 090358 for an AB-rated generic version of IMITREX STATdose (sumatriptan succinate) Injection, approved under NDA No. 020080, puts some meat on the bones of the Agency’s July 2009 consolidated response to two citizen petitions (here and here) submitted by King Pharmaceuticals, Inc. [read post]
1 Aug 2011, 8:19 am
The seven defendants, Actavis Elizabeth LLC, Sun Pharmaceuticals, Sandoz Inc., Mylan Pharmaceuticals, Apotex Inc., Aurobindo Pharma Ltd., and Teva Pharmaceuticals, had filed an Abbreviated New Drug Application (ANDA) seeking to utilize Lilly's patented formula and claiming invalidity of Lilly's patent, No. 5,658,590, Treatment of attention-deficit/hyperactivity disorder, which has been issued by the US Patent Office. [read post]
31 Jul 2011, 9:44 pm by Patent Docs
Hetero Drugs Ltd. et al. 1:11-cv-05135; filed July 26, 2011 in the Southern District of New York • Plaintiffs: Pfizer Inc.; Pfizer Ltd.; Pfizer Ireland Pharmaceuticals • Defendants: Hetero Drugs Ltd.; Hetero USA Inc.; Invagen Pharmaceuticals Inc.; Hetero Labs Ltd., Unit V Infringement of U.S. [read post]
10 Jul 2011, 9:20 pm by Patent Docs
• Defendants: Watson Pharmaceuticals, Inc.; Watson Laboratories, Inc.; Watson Laboratories, Inc. [read post]
30 Jun 2011, 2:13 pm by Phil
Patent No. 7,915,307...This action relates to an Abbreviated New Drug Application ("ANDA") filed by Mylan Pharmaceuticals, Inc. with the U.S. [read post]