Indian generic drug maker, Sun Pharmaceuticals has submitted an Abbreviated New Drug Application (ANDA) No. 78-738 to the US Food and Drug Authority (FDA) seeking approval for marketing and selling generic ophthalmic solution product containing 0.05% azelastine hydrochloride in an aqueous solution for use in treatment of seasonal allergic rhinitis. Sun’s proposed ANDA is bioequivalent product to MedPointe’s anti-allergic drug Optivar. On June 22, 2007 MedPointe files a civil motion for the infringement of the US Patent No. 5,164,194 (the ‘194 patent) in the US District Court for the District of Delaware against Sun Pharmaceuticals alleging that Sun’s proposed ANDA would constitute an infringement of the ‘194 patent under 35 USC § 271(e)(2) if approved prior to the expiration date of the ‘194 patent.
Dear Varun
ReplyDeleteBased on the expiry of US'194 which is May 01,2011:this being a Para-IV filing and Medipiont filing a civil motion for infringement thus triggering the 30 months stay period on FDA approval
Could you comment as to what would be the earliest possible date for SUN to Launch said product.
regards
Prashant