Glenmark receives ANDA approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC)

Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Olopatadine
Hydrochloride Ophthalmic Solution USP, 0.2% (OTC), determined by the FDA to be bioequivalent1
to Pataday®2 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
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.”