Glenmark Generics has received an approval for hydrocortisone butyrate cream USP, 0.1 per cent, abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) a generic version of Locoid Lipocream. In April 2011, Glenmark had entered into a royalty-bearing license agreement with Triax Pharmaceuticals, Astellas Pharma Europe and Astellas Pharma International to settle a patent infringement suit against the commercialisation of generic version of Locoid Lipocream and agreed to launch in near the end of CY 2013.
Glenmark is entitled to 180 days of exclusivity with respect to its hydrocortisone butyrate cream, as it is the first generic company to file an ANDA for the product. Hydrocortisone butyrate cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults and the treatment of mild to moderate atopic dermatitis in patients three months to 18 years of age.
According to IMS Health sales data for the 12 month period ending June 2013, hydrocortisone butyrate cream has garnered an annual sales of approximately $34 million. Glenmark’s current portfolio consists of 90 products authorised for distribution in the US marketplace and 53 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.
EP News Bureau – Mumbai
