Glenmark Pharma has announced that its US subsidiary, Glenmark Therapeutics Inc., has received approval from the US Food and Drug Administration (USFDA) for its Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC). This approval allows Glenmark to market the product in the US market, expanding its ophthalmic portfolio. The product is bioequivalent to Pataday Once Daily Relief Ophthalmic Solution, 0.2% (OTC), developed by Alcon Laboratories, Inc.
This approval is significant, as the Pataday brand is a popular treatment for relieving itchy, red, and irritated eyes. The annual sales of the Pataday product in the US market reached approximately $50.7 million, according to Nielsen syndicated data for the 52 weeks ending February 2025. Glenmark’s President and Business Head of North America, Marc Kikuchi, expressed his excitement about expanding the company’s over-the-counter (OTC) ophthalmic portfolio, stating that it reaffirms Glenmark’s commitment to providing high-quality, OTC eye care solutions for consumers.
The approval of Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC) marks a significant milestone for Glenmark Therapeutics Inc. in the US market. With this product, Glenmark is well-positioned to capitalize on the growing demand for OTC eye care solutions, providing consumers with a reliable and effective treatment option for their eye care needs.