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Glenmark’s US arm gets USFDA’s approval for Olopatadine Hydrochloride Ophthalmic Solution

21 Mar 2025 Evaluate

Glenmark Pharmaceuticals’ US-based subsidiary -- Glenmark Pharmaceuticals Inc, USA has received final approval by the United States Food & Drug Administration (USFDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC), determined by the FDA to be bioequivalent to Pataday Once Daily Relief Ophthalmic Solution, 0.2% (OTC), of Alcon Laboratories, Inc. Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (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 February 22, 2025, the Pataday Once Daily Relief Ophthalmic Solution, 0.2% (OTC) market3 achieved annual sales of around $50.7 million.

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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