2020-04-02
Pavel Kapysh / Shutterstock.com
13 August 2020AmericasRory O'Neill

FDA approves Dr Reddy’s Vascepa generic

Indian drugmaker  Dr Reddy’s has won approval to launch just the second generic version of heart drug  Vascepa (icosapent ethyl), in another blow for  Amarin.

London-based  Hikma Pharmaceuticals became the  first company to win approval for a Vascepa generic from the US Food and Drug Administration (FDA) in May.

The FDA’s approval of the generics comes after a  major patent victory for the two generics makers over Amarin earlier this year, when they had patents covering the drug invalidated.

Vascepa, a synthetic version of fish oil that’s used to lower triglyceride levels, was only approved by the FDA last year as a secondary therapy for reducing the risk of cardiovascular disease.

The US District Court for the District of Nevada then cancelled six Amarin patents, meant to last until 2030, after a challenge from the two generics makers.

In her decision, District Judge Miranda Du held that the patents were obvious in light of prior art, clearing the way for Hikma and Dr. Reddy’s to press ahead with abbreviated new drug applications (ANDAs) to the FDA.

But Amarin has appealed the ruling, and warned that if the generics launch too soon, Hikma and Dr Reddy’s could be liable if it is overturned.

An Amarin regulatory filing, dated April 30, stated: “If a generic drug company’s ANDA is approved by the FDA, and if such generic company has qualified supply available and elects to launch during the appeal process, it could be liable to the company for damages for patent infringement if Amarin prevails on appeal.”In the US Securities Exchange Commission filing, Amarin said that, while the appeal is ongoing, it will: “reduce the amount spent in the US on Vascepa-related education and promotion with the intention of retaining the capability to ramp-up promptly if Amarin wins upon appeal.”

The company said it could also launch its own Vascepa generic “separately from its branded version if the situation warrants such action”. Amarin is also investigating the potential use of Vascepa for treating COVID-19. A statement issued by the company in May suggested that the drug could have potential antiviral effects. No results from clinical trials have yet been published, according to the  US National Library of Medicine.

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More on this story

Americas
25 August 2020   A district judge has given India-based Dr Reddy’s the greenlight to move forward with its antitrust counterclaims against Indivior.
Big Pharma
4 September 2020   Amarin has announced it will seek an en banc rehearing of a decision at the US Court of Appeals for the Federal Circuit that failed to revive its patents on heart medicine Vascepa.
Americas
22 September 2020   Bristol Myers Squibb and Celgene have settled their patent litigation with Dr Reddy’s over a generic version of cancer drug Revlimid.

More on this story

Americas
25 August 2020   A district judge has given India-based Dr Reddy’s the greenlight to move forward with its antitrust counterclaims against Indivior.
Big Pharma
4 September 2020   Amarin has announced it will seek an en banc rehearing of a decision at the US Court of Appeals for the Federal Circuit that failed to revive its patents on heart medicine Vascepa.
Americas
22 September 2020   Bristol Myers Squibb and Celgene have settled their patent litigation with Dr Reddy’s over a generic version of cancer drug Revlimid.