Hikma gets FDA OK for generic fish-oil derivative

May 22, 2020

Hikma Pharmaceuticals announced that its U.S. subsidiary, Hikma Pharmaceuticals USA, won FDA approval for its generic equivalent to Amarin's Vascepa, a fish-oil derivative approved to cut cardiovascular risks in certain high-risk patients.

Vascepa, a type of omega-3 fatty acid — and Amarin's only product — won a long-awaited FDA approval for a new indication and label expansion in December to reduce the risk of cardiovascular disease.

Dr. Reddy’s Laboratories and Hikma Pharmaceuticals brought a patent lawsuit against Amarin and in March, the United States District Court for the District of Nevada invalidated six key Vascepa patents. The District Court decision is currently being appealed.

Given Amarin's ongoing appeal, analysts believe there is a low probability of a Hikma generic launch anytime soon.

Read the press release