Glenmark Pharmaceuticals Inc., USA (Glenmark) announced on Friday that it has received final approval from the United States Food & Drug Administration (U.S. FDA) for Abiraterone Acetate Tablets USP, 500 mg, the generic version of Zytiga®1 Tablets, 500 mg, of Janssen Biotech Inc.
The pharma company claimed that according to IQVIATM sales data for the 12-month period ending March 2022, the Zytiga® Tablets, 500mg market2 achieved annual sales of approximately $260.2 million.
According to the company’s press statement, Glenmark’s current portfolio consists of 173 products authorized for distribution in the U.S. marketplace and 49 Abbreviated New Drug Application (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.
Glenmark Pharmaceuticals was ranked among the world’s top 50 Generics and Biosimilars companies (Top 50 Company Rankings, 2020, from Informa’s Generics Bulletin). Moreover, the company has also been listed on the Dow Jones Sustainability Index (DJSI), under the category of emerging markets for the fourth consecutive year in a row, most recently in 2021.