Glenmark receives ANDA approval for Olopatadine Hydrochloride ophthalmic solution USP, 0.2%

Glenmark Pharmaceuticals, USA (Glenmark) 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 bioequivalent1 to Pataday2 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, 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 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.”