The U.S. Court of Appeals for the Federal Circuit recently upheld a ruling by the U.S. District Court for the District of Nevada finding that Hikma’s generic version of Vascepa (icosapent ethyl) 1 gm does not infringe any valid claim of six key Amarin-owned patents.
Hikma received Food and Drug Administration approval for the product in May 2020 and the company said that it is working toward launch.
Vascepa is indicated, in part, as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.
According to IQVIA, Vascepa has a market value of approximately $1.1 billion in the 12 months ending July 2020.
“We are very pleased with the Federal Circuit’s swift decision and to be one step closer to launching a generic version of this important medicine for U.S. patients and healthcare providers, helping us to continue putting better health, within reach, every day,” said Brian Hoffmann, Hikma generics president. “Today’s decision demonstrates Hikma’s ability to successfully challenge patents on important medicines and to provide value to our customers and millions of patients across the United States.”