Merck and Glenmark settle patent litigation on Zetia
This article was originally published in Scrip
Glenmark Pharmaceuticals can launch its generic version of Merck & Co's hypercholesterolaemia treatment, Zetia (ezetimibe), by 12 December 2016, as part of a settlement reached between the two companies over patent litigation concerning the product.
Glenmark had challenged Merck's basic compound patent, RE 37,721 on numerous grounds and sought to launch its generic version of Zetia before the 25 April 2017 expiry of Merck's patent. The settlement ends the lawsuit, which was to begin trial on 12 May in New Jersey. The litigation against Glenmark was originally initiated by Schering-Plough and MSP Singapore Company in 2007. Schering-Plough was acquired by Merck last year.
Glenmark said that it would be able to launch its generic version on 12 December 2016 or earlier under certain circumstances. Last April Glenmark Generics' US subsidiary announced that it had received tentative approval from the US FDA for ezetimibe 10mg tablets and that it had first-to-file status on the product, giving it a potential 180 days of marketing exclusivity (scripnews.com, 29 April 2009).
Last week, Glenmark Generics' US subsidiary entered into an exclusive licensing agreement with Par Pharmaceutical, the generic unit of Par Pharmaceutical Companies, US, to market ezetimibe 10mg tablets in the US.
Under the terms agreement, Par has made a payment to Glenmark for exclusive rights to market, sell and distribute ezetimibe in the US. The companies plan to share profits from the sales of the product. Par was also to share control and costs with Glenmark for ongoing litigation.