London, March 31, 2020 – Hikma Pharmaceuticals PLC (Hikma, Group), the multinational generic pharmaceutical company, today confirms that the United States District Court for the District of Nevada has ruled that Hikma’s generic version of Amarin Corporation’s Vascepa® (icosapent ethyl) 1 gm capsules does not infringe six United States Patents, as asserted by Amarin, because the asserted claims of these patents were held to be invalid.
31 March 2020
Press Release, Product
Hikma is working closely with the U.S. Food and Drug Administration (FDA) to gain approval for its Abbreviated New Drug Application (ANDA) for its generic version of Vascepa®. The company is evaluating its options for launching the product following FDA approval, including an at-risk launch in the event the District Court’s decision is appealed.
“We are very pleased with the District Court’s decision, which demonstrates our continued ability to successfully litigate to bring greater value to our customers and patients in the US,” said Brian Hoffmann, President of Generics, Hikma. “We look forward to providing patients and health care providers in the US with a generic version of this important medicine.”
Vascepa® is a prescription medicine that is indicated, in part, as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
According to IQVIA, US sales of Vascepa® were approximately $919 million in the 12 months ending February 2020.