Israel-based Teva Pharmaceutical Industries has won US FDA approval for a generic equivalent to GlaxoSmithKline’s fish-oil derived cardiovascular product Lovaza and will launch it immediately.
Teva said it believes it is the first company to file for approval of generic Lovaza (omega-3-acid ethyl esters capsules) and the first to secure marketing approval, which should give it six months of marketing exclusivity on the US market.
Lovaza is used to lower triglyceride levels in patients with cardiovascular disease and has annual sales of around $1.1bn in the US, according to IMS data cited by Teva. GSK acquired US rights to Lovaza – which was originally developed by Norway’s Pronova BioPharma – when it took over Reliant Pharmaceuticals in 2008 for $1.7bn.
Last year, the US Court of Appeals for the Federal Circuit cleared the way for generic versions of Lovaza, ruling that both Teva and Par Pharmaceuticals could proceed with plans to launch generic copies of Lovaza.
An earlier settlement between ProNova and Apotex gave the generics company rights to launch its own generic in the US early in 2015.
Aside from GSK, the launch of a lower-priced Lovaza generic in the US also impacts Amarin Pharmaceuticals’ Vascepa (icosapent ethyl), another fish oil-based therapy that is already on the market but was turned down by the FDA last October for use alongside statin drugs. Sales of Vascepa were around $26m in 2013, its first year on the market.
Also affected is AstraZeneca, which filed for approval of its own triglyceride-lowering drug Epanova last year. AZ acquired Epanova along with developer Omthera Pharmaceuticals in July 2013 in a $443m deal.