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Amarin Makes Vascepa Generics Prediction And Questions Supply

Federal Circuit Decision Anticipated Late 2020 Or Early 2021

 
• By Dean Rudge

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.

Crystal ball
Amarin is gearing up oral hearing of the Federal Circuit case on 2 September • Source: Shutterstock

Amarin does not anticipate Hikma or Dr Reddy's to introduce generic Vascepa (icosapent ethyl) until the US Court of Appeals for the Federal Circuit decides on Amarin’s appeal over the generics sponsors’ patent-litigation victories – and only then with a “limited supply,” according to the originator’s president and CEO, John Thero.

With an oral hearing of the appeals case planned for 2 September 2020, the Federal Circuit court decision is anticipated by Amarin later this year or early in 2021, as Amarin looks to overturn a Nevada district court ruling that invalidated as obvious six method-of-use patents shielding the hypertriglyceridemia treatment

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