Glenmark Pharmaceuticals Inc., USA, has received final approval from the U.S. Food & Drug Administration (FDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC). This product has been deemed bioequivalent to Pataday® Once Daily Relief Ophthalmic Solution 0.2% (OTC), manufactured by Alcon Laboratories, Inc.
Glenmark’s new over-the-counter (OTC) allergy eye drop will be distributed across the U.S. by Glenmark Therapeutics Inc., USA. Olopatadine Hydrochloride is an antihistamine used to relieve itchy and irritated eyes caused by allergies.
According to Nielsen® data, the Pataday® Once Daily Relief Ophthalmic Solution 0.2% market recorded annual sales of approximately $50.7 million for the 52-week period ending February 22, 2025.
Marc Kikuchi, President & Business Head, North America, expressed enthusiasm about the approval, stating, “We are pleased 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.”
This latest approval strengthens Glenmark’s position in the U.S. OTC ophthalmic segment, reinforcing its dedication to delivering high-quality, affordable healthcare solutions.
