Glenmark Generics Inc, USA (GGI), the United States subsidiary of Glenmark Generics Limited (GGL), announced the settlement of litigation pending between Glenmark and GlaxoSmithKline LLC (GSK) over patent actions concerning atovaquone and proguanil hydrochloride 250mg/100mg tablets, the generic version of GSK’s Malarone tablets.
Under the terms of the Settlement Agreements which are still subject to review by the Federal Trade Commission and the Department of Justice, Glenmark will be able to market and distribute its atovaquone / proguanil 250mg/100mg tablets under a royalty-bearing license from GSK in the 3rd quarter of calendar year 2011, or earlier under certain circumstances.
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. GSK currently markets its product as Malarone in the United States, indicated 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 USD 56 million.