Glenmark Gets USFDA Nod for Olopatadine Ophthalmic Solution

23 Mar 2025 , 11:40 AM

Glenmark Pharma on announced that its US subsidiary, Glenmark Therapeutics Inc, USA has been granted approval by the US Food & Drug Administration (USFDA) for its Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2 % (OTC). The product label will be available when the product is approved. The product is bioequivalent to Pataday Once Daily Relief Ophthalmic Solution, 0.2% (OTC), developed by Alcon Laboratories, Inc. This approval would allow Glenmark Therapeutics Inc., USA to market the product in the US market and would further fortify its ophthalmic portfolio.

Nielsen syndicated data for the 52 weeks ending February 22, 2025 showed annual sales of the Pataday Once Daily Relief Ophthalmic Solution, 0.2% (OTC) market of approximately $50.7 million. “We are excited to expand our OTC ophthalmic portfolio and with this launch, we are reaffirming Glenmark’s commitment to providing high quality, over-the-counter eye care solutions for consumers,” said Marc Kikuchi, President & Business Head of North America.