Amarin Makes Vascepa Generics Prediction And Questions Supply
Federal Circuit Decision Anticipated Late 2020 Or Early 2021
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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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.
In September, Dr Reddy’s and Hikma will brace themselves for the beginning of Amarin’s appeal over its Vascepa (icosapent ethyl) patent-litigation defeat, while the final financial results for the 30 June quarter and year-end will trickle in.
Dr Reddy’s Laboratories has leapfrogged Endo by launching a generic version of of Bayer/Alcon’s Ciprodex (ciprofloxacin/dexamethasone) 0.3%/0.1% otic suspension, as the US firm was stung with a major rejection by the US FDA.