Amarin Raises Supply Issue Again On US Vascepa Generics
Originator Eschews 2021 Guidance Following Hikma Launch
With Hikma having launched the first generic version of Vascepa (icosapent ethyl) in the US last year, Amarin has again raised the issue of ANDA product supply for the complex purified fish oil brand.
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Hikma expects healthy prospects for its US Advair generic in 2022, despite rival Teva recently receiving FDA approval for its own version. Meanwhile, Hikma CEO Siggi Olafsson also outlined expectations for generic competition on icosapent amid ongoing API shortages.
Dr Reddy’s has shaken up the market for generic Vascepa in the US by launching its own icosapent ethyl capsules to compete with Hikma’s generic and the Amarin brand, hot on the heels of the Supreme Court’s rejection of the originator’s attempt to overturn a Federal Circuit decision invalidating six Vascepa patents.
Teva was in position to introduce further generic competition to Amarin’s Vascepa following legal setbacks for the originator. However, the firm’s ANDA has since been listed as discontinued.