Andrx readies for Naprelan generic
Executive Summary
Andrx' launch of a generic version of Elan's extended-release naproxen Naprelan awaits FDA approval and resolution of exclusivity issues following Miami federal court ruling in favor of Andrx March 14. The court found Elan's patent (No. 5,637,320) to be invalid. Andrx' generic was tentatively approved in July 2001. The company maintains that Brightstone Pharma, which was first to file for generic Naprelan, lost exclusivity due to a court decision that it infringes Elan's patent...