Hikma receives FDA approval for its generic Vascepa®

Product, Press Release

Hikma receives FDA approval for its generic Vascepa®

London, May 22, 2020 – Hikma Pharmaceuticals PLC (Hikma), the multinational generic pharmaceutical company, today announces that its wholly owned U.S. subsidiary Hikma Pharmaceuticals USA Inc. has received approval from the US Food and Drug Administration (FDA) for its Icosapent Ethyl Capsules, 1 gm, the generic equivalent to Vascepa® [1].

In March 2020, the United States District Court for the District of Nevada invalidated six key Vascepa® patents owned by Amarin.  The District Court decision is currently being appealed.

Brian Hoffmann, President of Generics said, “The approval for our generic version of Vascepa® is an important milestone towards bringing this product to market. This approval demonstrates the strength of our regulatory capabilities and our commitment to provide patients and healthcare providers in the US with the high-quality medicines they need.”

[1] Vascepa® is a registered trademark of Amarin Pharmaceuticals Ireland Limited.