Sepracor jointly with University of Massachusetts has filed a civil action for patent infringement against Sun Pharmaceutical Industries alleging infringement of Orange Book listed US Patent Nos. 7,211,582 (the ‘582 patent), 7,214,683 (the ‘683 patent) and 7,214,684 (the ‘684 patent) for Clarinex tablets, generically known as Desloratidine. The complaint is filed in the US District Court for the District of New Jersey in response to Sun’s filing of an Abbreviated New Drug Application (ANDA) No. 78-359 under Para IV certification with the US FDA seeking approval of commercially market a generic version of Clarinex tablets prior to the expiration of the ‘582, ‘683 and ‘683 patents. Sepracor alleged that Sun’s ANDA product constitutes infringement of one or more of the claims of the ‘582, ‘683 and ‘684 patents under 35 USC § 271 (e) (2) (A).
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