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."

Hikma develops a broad and differentiated portfolio of generic, branded generic and in-licensed patented products through internal R&D, co-development partnerships, licensing agreements and acquisitions.

The company have 31 plants across the Group that services the global markets with a broad range of injectable and non-injectable products, including 11 US FDA-inspected plants and 11 EMA-inspected plants.