Latest Vascepa Lawsuit Plunges Hikma Into Induced Infringement Battle
Amarin Files Over Icosapent Ethyl Capsules And Cardiovascular Indication Patents
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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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.
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.
The AAM has stepped into controversial litigation between Teva and GSK over generic labelling carve-outs, urging the US Court of Appeals for the Federal Circuit to rehear the case to prevent the rules on so-called skinny labels from being subverted.