Glenmark launches generic Hydrocortisone Butyrate cream in US

Company is entitled to 180 days of exclusivity. It got approval from USFDA on Sept 27, 2013

Glenmark Pharmaceuticals today said its US arm has launched the generic Hydrocortisone Butyrate cream used for treating various skin conditions in the American market and is entitled to 180 days exclusivity.

"Glenmark Generics Inc, USA, the subsidiary of Glenmark Generics Ltd announces the exclusive launch of Hydrocortisone Butyrate cream USP, 0.1% in the United States," Glenmark Pharmaceuticals said in a statement.

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, it added.

The company received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for generic version of Astellas Pharma's Locoid Lipocream on September 27, 2013, Glenmark said.

According to IMS Health sales data for the 12 month period ending September 2013, Hydrocortisone Butyrate cream garnered annual sales of approximately $36.8 million, it added.

"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," Glenmark said.

The company's current portfolio consists of 90 products authorised for distribution in the US market and 56 ANDA's pending approval before the US health regulator, it added.

Shares of Glenmark Pharmaceuticals were trading at Rs 524.10 per scrip during afternoon trade on BSE today, down 0.19% from its previous close.