Glenmark Generics Inc., USA (GGI), the United States subsidiary of Glenmark Generics Limited (GGL), announced that they have been granted final approval for their Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration (US FDA) to market atovaquone and proguanil hydrochloride 250mg/100mg tablets, their generic version of GSK’s Malarone tablets, used in treating malaria .
In April 2010, the Company confirmed the settlement of litigation pending between Glenmark and GlaxoSmithKline LLC (GSK) over patent actions concerning atovaquone and proguanil hydrochloride 250mg/100mg tablets. 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 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.
The company’s current portfolio consists of 67 generic products authorized for distribution in the US market, as well as 39 ANDA’s filed with the US FDA pending approval. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.