Thursday, September 27, 2007

Wockhardt Certified Para IV for Comtan

Wockhardt has filed an Abbreviated New Drug Application (ANDA) No. 78-941 seeking the US FDA approval to market a generic version of entacapone before the expiration of the Orange Book listed Patent Nos. 5,446,194 (the ‘194 patent) titled ‘Pharmacologically active catechol derivatives’ and 5,135,950 (the ‘950 patent) titled ‘Stable polymorphic form of (E)-N, N-diethyl-2-cyano-3-(3, 4-dihydroxy-5-nitrophenyl) acrylamide and the process for its preparation.’ Entacapone is marketed in the US by Orion, through its partner Novartis under the brand name Comtan for treatment of Parkinson’s disease. In response to Wockhardt’s submission of the ANDA, Orion filed a civil action for patent infringement in the US District Court for the District of Delaware, alleging infringement of the ‘194 and ‘950 patents under 35 USC § 271 (e)(2)(A) and subsequently seeking declaratory judgment.

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