Glenmark Pharma gets final USFDA approval for generic version of Abiraterone Acetate tabs; shares gain

Glenmark Pharmaceuticals Ltd on Friday said that its US arm has received final approval from the US health regulator for its generic version of Abiraterone Acetate tablets used for the treatment of prostate cancer. 

"Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by 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," said the pharma company in a regulatory filing.  

According to IQVIATM sales data for the 12-month period ending March 2022, the Zytiga® Tablets, 500 mg market2 achieved annual sales of approximately $260.2 million*.  

As per the company, Glenmark’s current portfolio consists of 173 products authorized for distribution in the U.S. marketplace and 49 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. 

Meanwhile, shares of Glenmark Pharma gained more than two per cent to Rs 402.15 per share on the BSE in Friday's intraday trade. Glenmark pharma touched 52-week low of Rs 690.60 per share on July 19 last year, while it traded on a year low value of Rs  386.30 on May 12, 2022.