Glenmark Pharmaceuticals receives ANDA approval for Hydrocortisone Valerate Ointment USP, 0.2%
Mumbai, India, December 17, 2018: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Hydrocortisone Valerate Ointment USP, 0.2%, a generic version of Westcort®1 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 FDA.
According to IQVIATM sales data for the 12 month period ending October 2018, the Westcort® Ointment, 0.2% market2 achieved annual sales of approximately $11.1 million*.
Glenmark’s current portfolio consists of 145 products authorized for distribution in the U.S. marketplace and 55 ANDA’s pending approval with the U.S. 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.
1All brand names and trademarks are the property of their respective owners.
2Market includes brand and all available therapeutic equivalents
*IQVIATM National Sales Perspectives: Retail & Non-Retail, October 2018
About Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical organization. It is ranked among the top 75 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2018). Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has several molecules in various stages of clinical development and is focused in the areas of oncology, dermatology and respiratory.
The company has a significant presence in the branded generics markets across emerging economies including India. Glenmark has 16 manufacturing facilities across five countries and has six R&D centers. The Generics business of Glenmark services the requirements of the US and Western European markets. The API business sells its products in over 80 countries, including the US, various countries in the EU, South America and India.
For further information, please contact: Isha Trivedi
Glenmark, Mumbai, India
Tel: +91 22 4018 9801