Thursday, December 13, 2007

Sanofi Sued Glenmark for Patent Infringement

Reacting over the regulatory development of Glenmark’s submission of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration seeking approval to market generic Tarka prior to the expiration of the Orange Book listed patents, Sanofi-Aventis jointly with Abbott Laboratories has filed a civil action for the infringement of patent in the US District Court of New Jersey alleging that the proposed generic product will infringe one or more claims of Orange Book listed US Patent No. 5,721,244. Tarka is a combination extended release antihypertension oral tablet containing Trandolapril and Verapamil Hydrochloride having US $ 100 million sales in the US. It is believed that Glenmark is a First-to-File generic challenger and will be entitled to 180-day exclusivity period.

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