Glenmark Gains On US FDA Approval

Glenmark Generics Inc USA, the subsidiary of Glenmark has received US FDA approval for its generic Hydrocortisone Butyrate Cream which is indicated in the treatment of variety of skin infections. The company has emerged as a first company to file ANDA on this drug, hence this generic filing has got an FTF status which means that the company is entitled for 180 days of exclusivity in which it will be only company other than innovator to sell the drug.

In the press release, company has said "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 commercialisation of generic version of Locoid Lipocream and agreed to launch it near the end of CY 2013."

As per the data of IMS Health, the drug grossed USD 34 million in sales for the 12 month period ending June 2013. The drug is currently sold by Triax under the brand name Locoid Lipocream.

The company also said that its current portfolio consists of 90 products authorised for distribution in the US market and 53 ANDA's pending approval with the USFDA.

Shares of the company gained 1.55% to close on Rs 531 apiece.