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

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."

Shares of Glenmark Pharmaceuticals Limited was last trading in BSE at Rs. 1478.15 as compared to the previous close of Rs. 1486.55. The total number of shares traded during the day was 4815 in over 627 trades.

The stock hit an intraday high of Rs. 1501.35 and intraday low of 1474.60. The net turnover during the day was Rs. 7133972.00.

Source : Equity Bulls

Keywords

GlenmarkPharmaceuticals INE935A01035 USFDA ANDAApproval OlopatadineHydrochloride OphthalmicSolution