Amarin Raises Supply Issue Again On US Vascepa Generics
Originator Eschews 2021 Guidance Following Hikma Launch
Executive Summary
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 addressed supply concerns and the latest legal worries for its generic Vascepa product, as well as the recent launch of its long-awaited Advair generic, as management faced the virtual J.P. Morgan Healthcare Conference.
Hikma’s Vascepa Launch Strategy ‘Can Cause Market Confusion’
Issues over supply and the use of a skinny label have the potential to take a toll on the market for the fish oil drug icosapent ethyl, one analyst has claimed in the wake of Hikma’s recent generic launch.
Latest Vascepa Lawsuit Plunges Hikma Into Induced Infringement Battle
Hikma has pushed back against a further attempt by Amarin to counter its US generic version of Vascepa, this time via a fresh lawsuit claiming that the generic induces infringement of patents protecting cardiovascular indications for which the brand is approved but which are carved out of the generic label.
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