A court ruling invalidating Amarin Corp. PLC's Vascepa (icosapent ethyl) patents means generic companies could launch their versions of the fish oil pill at-risk once the US Food and Drug Administration approves their abbreviated new drug applications. But analysts predict they will wait to enter the market until sometime next year, at which time Amarin will have to rely on the market outside the US where the company has additional patent protection.
In a 30 March order, the US District Court for the District of Nevada concluded that Hikma Pharmaceuticals PLC, Dr. Reddy's Laboratories Ltd