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Amarin Makes Vascepa Generics Prediction And Questions Supply

Federal Circuit Decision Anticipated Late 2020 Or Early 2021

Executive Summary

Amarin – and the industry at large – was stunned in March this year when Hikma and Dr Reddy’s walked away from court with an invalidity ruling against six Vascepa patents in the US. The originator’s CEO gave an impassioned update on the current state of play, including the potential for generics to launch ahead of a Federal Circuit ruling later this year or early in 2021.

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Amarin has confirmed that it plans to take its legal battle over Vascepa all the way to the US Supreme Court, as it seeks to overturn a ruling that has already allowed Hikma to launch its generic rival.

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Hikma has launched its US rival to Vascepa, after the US Court of Appeals for the Federal Circuit refused a request by Amarin for an “en banc” rehearing of key litigation.

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Hikma and Dr Reddy’s Laboratories are weighing launches of their generics to Amarin’s Vascepa after the US Court of Appeals for the Federal Circuit upheld a favorable lower court ruling. The originator said it would take its appeal to the next level and continued to raise doubts over supply capacity.

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