Glenmark gets USFDA nod for Esomeprazole Magnesium DR Capsules USP, 20 mg

Glenmark Specialty SA (Glenmark) has received final approval by the United States Food & Drug Administration (US FDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC), determined by the FDA to be bioequivalent to Nexium, 24 HR Delayed-Release Capsules, 20 mg (OTC), of Haleon US Holdings 

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC), will be distributed in the US by Glenmark Therapeutics, USA. According to Nielsen syndicated data for the latest 52 weeks period ending May 18, 2024, the Nexium 24 HR Delayed-Release Capsules, 20 mg (OTC) market achieved annual sales of approximately $259.2 million*. 

Glenmark’s current portfolio consists of 197 products authorised for distribution in the US. marketplace and 50 ANDA’s pending approval with the USFDA. 

*Nielsen NIQ Discover; Syndicated Data for Period Ending May 18, 2024