Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the FDA 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 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.”
References
Glenmark’s Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC) is only marketed for the indications listed in Glenmark’s approved drug facts label.
This product is not manufactured or distributed by Alcon Laboratories, Inc., distributor of Pataday Once Daily Relief, and/or Novartis AG, owner of the registered trademark Pataday, respectively. [Neither Alcon nor Novartis make or license Glenmark’s product.]
Market includes brand and all available therapeutic equivalents. Note: Nielsen syndicated data obtained by Glenmark is only available for all approved RLD indications. Glenmark’s product is only approved for the indications listed in Glenmark’s approved label and is not marketed for all RLD indications.