Wednesday, July 16, 2008

Abbott Files Para IV Litigation Against Dr. Reddy's Labs

Abbot Laboratories has filed an infringement lawsuit against Hyderabad-based Dr. Reddy’s Laboratories for the infringement of US Patent Nos. 6,511,678, 6,528,090, 6,713,086 and 6,720,004 following DRL paragraph IV certification as part of an abbreviated new drug application (ANDA) to manufacture a generic version of Depakote ER (divalproex sodium extended release tablet). Depakote ER is anti-seizure drug with US sales of $1.48 billion in 2007. The lawsuit is filed in the United States District Court for the District of New Jersey. In 2005 and 2007, Abbott filed similar infringement lawsuits against Mylan, Impax Laboratories, Teva and Wockhardt Ltd. but earlier this year entered into agreement with Mylan to allow launching a generic version no later than January 1, 2009. Mylan believes to have 180-day exclusivity period for 500 mg strength and under terms of agreement also obtained a license for the 250mg strength tablets to be launched no later than January 1, 2009.

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