Hikma receives favourable ruling in generic Vascepa patent suit from US Court
31 March 2020 -

Generic pharmaceutical company Hikma Pharmaceuticals PLC reported on Monday that the US District Court for the District of Nevada has ruled that its generic version of Amarin Corporation's Vascepa (icosapent ethyl) 1 gm capsules does not infringe six US Patents, as asserted by Amarin, because the asserted claims of these patents were held to be invalid.

Following the US Court's favourable ruling, Hikma said it is working closely with the US Food and Drug Administration (FDA) to acquire 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.

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 USD919m in the 12 months ending February 2020.