FDA Approves Hikma's Generic Vascepa Amid Fed. Circ. Fight

Law360 (May 22, 2020, 6:46 PM EDT) -- Hikma Pharmaceuticals on Friday announced that the U.S. Food and Drug Administration has approved its generic version of Amarin Pharma Inc.'s heart drug Vascepa, amid the companies' ongoing patent battle at the Federal Circuit.

The announcement comes a few months after a Nevada federal court ruled in favor of Hikma and held that Amarin's patents for the drug were invalid. The case is now on appeal at the Federal Circuit, which has sped up the briefing schedule.

"The approval for our generic version of Vascepa is an important milestone towards bringing this product to market," Brian Hoffmann, Hikma's president of generics,...

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