Glenmark receives ANDA approval for Hydrocortisone Valerate Ointment

The company is eligible for 180 days of CGT exclusivity upon commercialisation

Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (US FDA) for Hydrocortisone Valerate Ointment USP, 0.2 per cent, a generic version of Westcort 1 Ointment, 0.2 per cent, of Sun Pharmaceutical Industries. Glenmark has been granted a competitive generic therapy (CGT) designation for Hydrocortisone Valerate Ointment USP, 0.2 per cent, therefore, with this approval, Glenmark is eligible for 180 days of CGT exclusivity upon commercialisation. This is Glenmark’s first granted CGT product approved by the FDA.

According to IQVIATM sales data for the 12 month period ending October 2018, the Westcort Ointment, 0.2 per cent market achieved annual sales of approximately $11.1 million. Glenmark’s current portfolio consists of 145 products authorised for distribution in the US marketplace and 55 ANDA’s pending approval with the US FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.