Hikma Gets More Time On Vascepa Response As Amarin CEO Exits
ANDA Sponsor Argued Unsuccessfully For A 45-Day Extension
Hikma has won more time to respond to Amarin’s certiorari petition to the US Supreme Court over a Federal Circuit decision invalidating Vascepa intellectual property – but not the 45 days the company was looking for. Meanwhile, Amarin’s CEO John Thero is to stand down later this year.
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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.
Having sat on an approved Vascepa ANDA since August last year, Dr Reddy’s Laboratories has sued originator Amarin, claiming the firm has illegally cornered the market for the hard-to-manufacture active ingredient.
Four key “moving pieces,” including the next developments for rivals to Advair and Vascepa, will influence the success of Hikma’s US generics business, CEO Siggi Olafsson tells Generics Bulletin in the first part of an exclusive interview.