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FDA Approves Generic Version of Amarin's Blockbuster Fish Oil Capsules

By Cory Renauer – May 22, 2020 at 12:23PM

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The arrival of a generic version of Vascepa will be bad news for the company.

Millions of Americans who would like to lower their risk of a heart attack could have a new, low-cost option to help them. On Friday, the FDA approved 1 gram Icosapent Ethyl Capsules from Hikma Pharmaceuticals (HKMP.Y 0.04%). Hikma's capsules are the generic equivalent of Vascepa from Amarin (AMRN 2.73%), a branded fish oil product expected to drive billions in annual sales.

Cherry-picking for the win 

For more than a decade, Amarin has been running huge deficits to develop Vascepa, and now, Hikma's version can legally claim to provide the same benefits. In March, shares of Amarin tanked after a judge on the U.S. District Court of Nevada ruled in favor of Hikma and another generic drugmaker, Dr. Reddy's Laboratories (RDY 1.30%).

FDA stamp of approval

Image source: Getty Images.

Unlike other fish oil supplements, Vascepa capsules contain just one omega-3 fatty acid: icosapent ethyl. In 2011, Amarin began enrolling thousands of people at risk of heart attacks into the REDUCE-IT study to see if adding this proprietary fish oil formulation to their regular regimens of cholesterol drugs would help them avoid heart attacks over the long term. Surprisingly positive results in 2018 led Amarin and most investors to expect years of patent-protected sales for Vascepa as a therapy to lower the risk of cardiovascular events for people with high triglycerides plus either diabetes or established cardiovascular disease.

It's not over yet

The district court decision that invalidated six of Amarin's key Vascepa patents isn't set in stone just yet. Both parties have requested the U.S. Court of Appeals for the Federal Circuit to review Amarin's appeal on an expedited schedule. If that request is granted, we can expect a briefing before the end of June, and a hearing in the second half of the year.

Cory Renauer has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

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Stocks Mentioned

Amarin Corporation plc Stock Quote
Amarin Corporation plc
$1.13 (2.73%) $0.03
Dr. Reddy's Laboratories Limited Stock Quote
Dr. Reddy's Laboratories Limited
$50.55 (1.30%) $0.65
Hikma Pharmaceuticals PLC Stock Quote
Hikma Pharmaceuticals PLC
$26.62 (0.04%) $0.01

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