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Hikma Pharma Gets Favorable U.S. Ruling In Generic Vascepa

Generic pharmaceutical company Hikma Pharmaceuticals PLC (HIK,HIK.L) on Tuesday announced favorable U.S. ruling in Generic Vascepa.

The company confirmed that the U. S. District Court for the District of Nevada has ruled that Hikma's generic version of Amarin Corp.'s Vascepa (icosapent ethyl) 1 gm capsules does not infringe six United States Patents, as asserted by Amarin. The Court said the asserted claims of these patents were held to be invalid.

Hikma said it is working closely with the U.S. Food and Drug Administration to gain approval for its Abbreviated New Drug Application or 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 hypertriglyceridemia.

According to IQVIA, US sales of Vascepa were approximately $919 million in the 12 months ending February 2020.

In London, Hikma shares were trading at 2,038.85 pence, up 3.78 percent.

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