Apotex And Amarin Settle On Vascepa
US Market Entry Date Of 2029 Matches Teva Settlement
Apotex has settled patent litigation over Vascepa with Amarin, providing the generics firm with a guaranteed launch date in 2029.
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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.
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.
Hikma has eyes on launching a generic of Amarin’s Vascepa in the US following FDA approval and a favorable patent ruling at the district level in March. However, with a swift appeal filed by the originator in the works, the Jordanian firm is yet to pull the trigger.