Generics of fish oil cholesterol treatment get go ahead

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Generics of fish oil cholesterol treatment get go ahead

Generics/News | Posted 04/10/2013 0 Post your comment

A US appeals court ruled on 12 September 2013 that generics companies can develop their own versions of Lovaza, a fish oil-derived drug used to treat high cholesterol, which is currently marketed in the US by GlaxoSmithKline (GSK).

Pronova Biopharma Norge (Pronova) alleged patent infringement against Par Pharmaceutical (Par) and Teva Pharmaceutical Industries (Teva) in 2009, after the generics makers both filed abbreviated new drug applications with FDA for generic versions of Lovaza (omega-3-acid ethyl esters).

The US Court of Appeals for the Federal Circuit ruled against Pronova overturning a previous decision in favour of the company, which was recently bought by German chemicals firm BASF. The ruling by the Federal Court gives generics companies Par and Teva the right to bring out generic versions of Lovaza to treat very high triglyceride levels.

The Lovaza patents are owned by Pronova and licensed to GSK. The patents relate to compositions and methods of using omega-3 fatty acids. GSK has marketing rights for Lovaza in the US and Puerto Rico. US sales of the drug in 2011 were US$916 million.

Lovaza is the first and only fish oil-derived prescription drug approved by FDA. GSK stated that Lovaza remains available and the company is not aware that FDA has approved any generics to date.

The ruling is also expected to affect sales of Amarin’s Vascepa (icosapent ethyl), a rival medicine, which is also approved to lower very high triglyceride levels.

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Source: GSK