Glenmark Gets US FDA Approval for Olopatadine Hydrochloride Solution

Glenmark Pharmaceuticals Inc., USA (Glenmark), a research-led, global pharmaceutical company, has received final approval by the United States Food & Drug Administration (FDA) 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 US 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) market achieved annual sales of approximately $50.7 million.
 
Commenting on the launch, Marc Kikuchi, president & business head, North America said, “We are pleased to continue to expand our OTC ophthalmic portfolio. The addition of olopatadine hydrochloride ophthalmic solution USP, 0.2% highlights our commitment to meeting market needs and providing quality over-the-counter solutions for our customers.”
 
Glenmark Pharmaceuticals Ltd. is a research-led, global pharmaceutical company, having a presence across branded, generics, and OTC segments; with a focus on therapeutic areas of cardio-metabolic, respiratory, dermatology and oncology.

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