Glenmark’s arm gets USFDA’s approval for Esomeprazole Magnesium Delayed-Release Capsules

12 Jun 2024 Evaluate

Glenmark Pharmaceuticals’ subsidiary-- Glenmark Specialty S A has received final approval by the United States Food & Drug Administration (USFDA) 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 U.S. Holdings LLC. Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC), will be distributed in the U.S. by Glenmark Therapeutics Inc., 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 authorized for distribution in the U.S. marketplace and 50 ANDA’s pending approval with the USFDA. 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 is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries. 


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