Glenmark Generics Inc., USA, the US subsidiary of Glenmark Pharmaceuticals Limited (GPL), today announced that it has settled patent issues with GlaxoSmithKline (GSK) concerning atovaquone and proguanil hydrochloride tablets, the generic version of GSK's Malarone tablets use in the treatment of malaria.
Under the terms of the agreements, which are still subject to review by the US Federal Trade Commission and the Department of Justice, Glenmark will be able to market and distribute its atovaquone / proguanil 250mg and 100mg tablets under a royalty-bearing license from the London-based GSK in the 3rd quarter of calendar year 2011, or earlier under certain circumstances.
Glenmark said in a statement that it believes that it is entitled to 180 days of exclusivity with respect to its atovaquone / proguanil tablets as the first generic to file an Abbreviated New Drug Application (ANDA) for the drug.
ANDA is an application filed for a generic drug approval in the US for an existing licensed approved drug. GSK, the UK's biggest pharmaceutical company, currently markets its product as Malarone in the US, a drug prescribed for the prevention and treatment of malaria.
The IMS Health has reported that the total US sales of Malarone for the 12 month period ending December 2009 were approximately $56 million.
Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark) and aims to be a global integrated Generic and API leader.
GGL has an established presence in North America, a developing EU presence and Argentina and maintains marketing front-ends in these countries. It primarily sells its FDF products in the US and the European Union, as well as its oncology FDF products in South America.'
The Company supplies APIs to customers in approximately 63 countries, including the US, various countries in the EU, South America and India.
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