Ramelteon (Rozerem) 8 mg Tablets: Watson filed ANDA with Para IV certification

Watson Pharmaceuticals confirmed (in a press release Here ) that its subsidiary, Watson Laboratories filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market Ramelteon (Rozerem) 8 mg Tablets.

Innovator has listed following patent in the Orange Book for this product:

US6034239 (Expiry: Mar 6, 2017): The patent covers Ramelteon as product

Subsequently, in an attempt to block generic version of Ramelteon (Rozerem) 8 mg Tablets, innovator Takeda has filed an infringement action (based on '239 Patent) against generic player Watson in U.S. District Court for the District of Delaware. Earlier, innovator has sued generic player Teva for filing ANDA with Para IV certification.

As per press release, Watson believes it may be a "first applicant" to file an ANDA for Ramelteon (Rozerem) 8 mg Tablets, accordingly, may be entitled to 180 days of shared generic market exclusivity.

Earlier, innovator got approval to market Ramelteon (Rozerem) 8 mg Tablets on Jul 22, 2005. For the twelve months ending September 30, 2009 Ramelteon (Rozerem) 8 mg Tablets had total U.S. sales of approximately $91 million according to IMS Health data.

Atorvastatin (Lipitor): Pfizer sued Kremer-Urbans LLC and KUDCO for the infringement of Polymorph patent

Innovator Pfizer has sued generic player Kremer-Urbans LLC and its partner KUDCO for filing ANDA with Para IV certification against Orange Book listed patent for Atorvastatin (Lipitor) tablets in the U.S. District Court for the District of Delaware

Innovator has asserted following polymorph patent against generic player:

US5969156 (Expiry: June 8th, 2017): Which covers various hydrated Polymorphs of Atorvastatin (Form I, II and IV)

As per complaint filed in the U.S. District Court for the District of Delaware, innovator has requested court to block generic version till the expiry of crystalline polymorphic form patent.

The other Para IV filers on this product are Teva, Cobalt, Apotex, Matrix (Mylan), Dr. Reddy and Kremer-Urbans LLC and KUDCO

Earlier, Ranbaxy (First para IV filer) had settled its pending patent litigation on Lipitor and Caudet on June 18, 2008 and will launch its generic product in November, 2011