Glenmark Pharmaceuticals – subsidiary -- Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Hydrocortisone Valerate Ointment USP, 0.2%, a generic version of Westcort Ointment, 0.2%, of Sun Pharmaceutical Industries, Inc.
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 USFDA.
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 Pharmaceuticals is a global pharmaceutical company. The company is engaged in the development of new chemical entities (NCEs) and new biological entities (NBEs). Its segments are India, United States, Latin America, Europe and Rest of the World (ROW).
