Glenmark receives ANDA approval for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC)

Glenmark Specialty SA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC), determined by the FDA to be bioequivalent¹ to Nexium®² 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) market³ 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 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.