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26 May 2020AmericasRory O'Neill

FDA approves Hikma’s Vascepa generic

London-based  Hikma Pharmaceuticals has won approval to launch the first generic version of  Vascepa (icosapent ethyl), after having key  Amarin patents for the heart drug invalidated.

In late March, the US District Court for the District of Nevada  cancelled six Amarin patents, previously set to last until 2030, after a challenge from Hikma and Indian drugmaker Dr Reddy’s.

The UK-based multinational has now won approval from the US Food and Drug Administration (FDA) for a Vascepa generic, which would be the first to hit the market since the ruling.

Brian Hoffmann, Hikma’s president of generics said: “The approval for our generic version of Vascepa is an important milestone towards bringing this product to market. This approval demonstrates the strength of our regulatory capabilities and our commitment to provide patients and healthcare providers in the US with the high-quality medicines they need.”

Amarin is still appealing the Nevada district court’s ruling, meaning there may be further obstacles down the line for generic versions coming to market.

Dr Reddy’s has also filed an abbreviated new drug application (ANDA) for its own Vascepa generic.

An Amarin regulatory filing, dated April 30, warned the generics makers that if they launch too soon, they could be liable for damages: “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 backing a clinical trial investigating potential benefits from Vascepa in treating COVID-19.

“Based on our current understanding of the biological effects of a COVID-19 infection ... it is believed that Vascepa could play a beneficial clinical role in helping patients infected by the virus,” an  Amarin statement said.

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Americas
1 April 2020   A US judge has opened the door to generic versions of heart disease drug Vascepa, after invalidating Amarin’s key patents covering the drug.
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More on this story

Americas
1 April 2020   A US judge has opened the door to generic versions of heart disease drug Vascepa, after invalidating Amarin’s key patents covering the drug.
Americas
11 May 2020   The US Court of Appeals for the Federal Circuit has affirmed a generic maker’s victory over pharmaceutical company Eagle Pharmaceuticals in a case involving cancer drug Belrapzo.
Americas
13 August 2020   Indian drugmaker Dr Reddy’s has won approval to launch just the second generic version of heart drug Vascepa, in another blow for Amarin.

More on this story

Americas
1 April 2020   A US judge has opened the door to generic versions of heart disease drug Vascepa, after invalidating Amarin’s key patents covering the drug.
Americas
11 May 2020   The US Court of Appeals for the Federal Circuit has affirmed a generic maker’s victory over pharmaceutical company Eagle Pharmaceuticals in a case involving cancer drug Belrapzo.
Americas
13 August 2020   Indian drugmaker Dr Reddy’s has won approval to launch just the second generic version of heart drug Vascepa, in another blow for Amarin.