“Glenmark has been granted a competitive generic therapy (CGT) designation for Hydrocortisone Valerate Ointment USP, 0.2%, therefore, with this approval; Glenmark is eligible for 180 days of CGT exclusivity upon commercialization. This is Glenmark’s first granted CGT product approved by the FDA,” Glenmark Pharma said in a regulatory filing.
According to IQVIATM sales data for the 12 month period ending October 2018, the Westcort Ointment, 0.2% market achieved annual sales of approximately $11.1 million.
Glenmark’s current portfolio consists of 145 products authorized for distribution in the US marketplace and 55 ANDA’s pending approval with the United States Food & Drug Administration (USFDA), the company said.
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, it added.
At 09:57 am, Glenmark Pharma was up 4% at Rs 692 on BSE, as compared to a 0.59% rise in the S&P BSE Sensex. It was trading close to its 52-week high of Rs 712 touched on September 10, 2018, on BSE in the intra-day trade. A combined 1.2 million equity shares changed hands on the counter on the BSE and NSE so far.