Supply Chain Constraints ‘Will Limit Vascepa Threat’
Dr Reddy’s And Hikma Have Path To Market
Supply is the million-dollar question for Vascepa ANDA sponsors, with Dr Reddy’s and Hikma receiving a further green light to introduce their generics into the US market.
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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.
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.
Hikma has launched its US rival to Vascepa, after the US Court of Appeals for the Federal Circuit refused a request by Amarin for an “en banc” rehearing of key litigation.