Glenmark receives USFDA approval for Hydrocortisone Butyrate Cream USP, 0.1 %

30 Sep 2013 Evaluate

Glenmark Generics Inc., USA the subsidiary of Glenmark Generics (GGL) has received an approval from United States Food and Drug Administration (USFDA) for Hydrocortisone Butyrate Cream USP, 0.1%, abbreviated new drug approval (ANDA), a generic version of Locoid Lipocream. GGL is subsidiary of Glenmark Pharmaceuticals.

In April 2011 Glenmark had entered into a royalty-bearing license agreement with Triax Pharmaceuticals, Astellas Pharma Europe BV and Astellas Pharma International BV to settle a patent infringement suit against the commercialization 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 3 months to 18 years of age. According to IMS Health sales data for the 12 month period ending June 2013, Hydrocortisone Butyrate Cream garnered annual sales of approximately $34 million.

Glenmark’s current portfolio consists of 90 products authorized for distribution in the US marketplace and 53 ANDA’s pending approval with the USFDA. 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.

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