The United States Food and Drug Administration (FDA) has granted tentative approval for Glenmark Generics Inc. (GGI), the US subsidiary of Glenmark Generics Ltd, montelukast sodium 10 mg tablets, the generic version of Singulair tablets by Merck.
Singulair is indicated for the prophylaxis and chronic treatment of asthma in adults and paediatric patients 12 months of age and older; for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older; for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older.
IMS Health has recorded sales of Singulair 10 mg tablets for the 12 month period ending September 2011, as US$ 3.2 billion. Based on the tentative approval for montelukast sodium tablets, Glenmark Generics should be able to launch the product upon patent expiry in August 2012.
Glenmark’s current portfolio consists of 73 products authorized for distribution in the US marketplace. The Company has over 40 ANDA’s pending approval with the US FDA. 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.