Glenmark Pharmaceuticals said on Monday its US-based group company has settled a patent dispute with GlaxoSmithKline over the launch of a generic version of anti-malaria drug Malarone.
Glenmark Generics Inc has settled the litigation pending between the company and GSK over patent actions concerning atovaquone and proguanil hydrochloride 250mg/100mg tablets, the generic version of GSK's Malarone tablets, Glenmark Pharma said.
Under the terms of the settlement agreements, Glenmark will be able to market and distribute its atovaquone/proguanil 250mg/100mg tablets under a royalty-bearing licence from GSK in the third quarter 2011, or earlier under certain circumstances, it said.
The settlement agreements are still subject to review by the Federal Trade Commission and the Department of Justice, Glenmark said.
"Glenmark believes that it is entitled to 180 days of exclusivity with respect to its atovaquone/proguanil 250 mg/100mg tablets as the first generic to file an ANDA for the product," the company said.
GSK currently markets its product as Malarone in the US, for the prevention and treatment of malaria. Total US sales as reported by IMS Health for the 12 month period ending December 2009 were approximately $56 million.
Glenmark Generics Inc is the US subsidiary of Glenmark Generics Ltd, which is a subsidiary of Glenmark Pharma.
Glenmark Generics Ltd is planning an initial public offer and has filed a Draft Red Herring Prospectus with Securities and Exchange Board of India.
Shares of Glenmark Pharma were quoting at Rs 276.50, down by 1.11 per cent in the morning trade on the National Stock Exchange.
