Hikma Pharmaceuticals announced Friday that the FDA has approved its generic version of Amarin's Vascepa (icosapent ethyl), making it the first generic of the fish-oil-derived drug cleared in the US. Vascepa, which was first approved by the FDA in 2012 for severe hypertriglyceridaemia, saw its label expanded last December to include use as an adjunctive therapy to lower the risk of cardiovascular events in adults with triglyceride levels of 150 mg/dL or more.
The latest FDA approval comes shortly after a US district court in Nevada invalidated six key Vascepa patents owned by Amarin in a decision that is currently under appeal (for related analysis, see ViewPoints: Soon to be plenty of fish in Amarin's sea). Amarin had sued Hikma citing infringement on the patents, which are set to expire in 2030. The court ruling sunk Amarin's shares as much as 70% the day it came down on March 30. At the time of the ruling, Hikma indicated that it was evaluating its launch options, including an at-risk launch in the event Amarin appeals the district court's decision.
Brian Hoffmann, president of Hikma's generics unit, said Friday that "the approval for our generic version of Vascepa is an important milestone towards bringing this product to market." Aside from Hikma, Dr Reddy's Laboratories is also said to be looking to introduce its own Vescepa generic in the US.
Amarin reported sales totalling $429.8 million last year, up 87% over 2018, growth the company attributed mainly to higher Vascepa revenues in the US.
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