Glenmark Generics Inc., USA, the subsidiary of Glenmark Generics Limited, has launched hydrocortisone butyrate cream USP, 0.1 per cent in the United States. The Company received approval from the United States Food and Drug Administration (FDA) for Abbreviated New Drug Application (ANDA) for its generic version of Locoid Lipocream on September 27, 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 September 2013, hydrocortisone butyrate cream garnered annual sales of approximately US$ 36.8 million.

Glenmark’s current portfolio consists of 90 products authorized for distribution in the US marketplace and 56 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.