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FDA Approves First Generic Version Of Vascepa; Amarin On Watch

Hikama Pharmaceutical LLC (HKMPY.OB) has received FDA approval to market its generic version of the brand drug Vascepa.

The brand drug Vascepa, developed by Amarin Corp. (AMRN), is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia, and as an adjunct to statin therapy to reduce the risk of cardiovascular events.

The drug brought in annual sales of $427 million for Amarin in 2019 compared to $228 million in 2018.

In March of this year, the patents covering Vascepa were invalidated by a Nevada district judge, favoring Hikma and Dr. Reddy's Labs, paving the way for generic versions of the drug to be launched in the U.S.

Amarin has appealed the ruling of the Court.

Assuming the Federal Circuit (three-judge panel) likely hears the appeal in early September or early October, a decision can be expected in late 2020 or early 2021.

AMRN closed Thursday's trading at $7.28, down 2.41%.

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