Glenmark,Merck settle patent row

Glenmark Pharmaceuticals has settled a patent litigation with Merck amp; Co over its cholesterol lowering generic drug Ezetimibe. Ezetimibe is a generic version of Merck-Schering Ploughs patented drug Zetia. With the settlement,Glenmark can sell the drug in the US market. The settlement comes around a month after Glenmark settled a patent dispute with GlaxoSmithKline over the launch of a generic version of its anti-malaria drug,Malarone.

Glenmark and Merck were fighting a patent litigation in the US court after the Indian firm had filed an abbreviated new drug application ANDA with first-to-file status that entitled it a potential of 180 days of marketing exclusivity in the US. Under the agreement,Glenmark will be able to launch its product on December 12,2016,or earlier under certain circumstances,ahead of the April 25,2017 expiration of Mercks patent exclusivity for Zetia, the company said in a statement. According to industry experts,the development could give Glenmark an opportunity to earn around 200 million about Rs 700 crore through the launch of the drug in the American market with exclusivity.

Zetia has annual sales of around 1.4 billion in the US alone,a Glenmark spokesperson said. Glenmarks shares were down 1.68 to close at Rs 272.90 on the BSE on Tuesday.

This settlement effectively ends the lawsuit involving a challenge by Glenmark which sought to launch a generic version of Zetia before the April 2017 expiration of the patent exclusivity covering Zetia. Glenmark had filed an abbreviated new drug application with the US Food and Drug Administration seeking regulatory approval on October 25,2006,and the company had got the tentative approval for the drug last year through its US-based subsidiary Glenmark Generics for Ezetimibe tablets in 10 mg strength.