Sepracor jointly with University of Massachusetts has filed a complaint for patent infringement in the US District Court for the District of New Jersey to safeguard its patent rights over Clarinex, generically extended release tablet containing desloratadine and pseudoephedrine sulfate against the generic manufacturer Dr. Reddy’s Laboratories (DRL) prior to the expiration of the Orange Book listed Patent Nos. 7,214,683 (the ‘683 patent) and 7,214,684 (the ‘684 patent). Earlier, DRL made an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration seeking approval to market generic extended release tablet containing desloratadine and pseudoephedrine along with the Para IV certification, alleging both ‘683 and ‘684 patents invalid. In its complaint, Sepracor alleged submission of DRL ANDA would constitutes infringement of the ‘683 and ‘684 patents under 35 USC 271 (e) (2) (A).
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