Teva Vascepa ANDA Is ‘Discontinued’ Despite Settlement Agreement
Amarin CEO Speculates On New Status
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.
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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.
US healthcare insurance provider Health Net failed to respect Amarin’s patent rights in the way it distributed Hikma’s generic version of Vascepa (icosapent ethyl), the originator contends in an expanded induced infringement suit.
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.