Glenmark Pharmaceuticals Secures USFDA Nod for OTC Olopatadine Hydrochloride Ophthalmic Solution

Glenmark Pharmaceuticals Ltd announced on Thursday, 20 March, that its subsidiary, Glenmark Therapeutics Inc., USA, has received final approval from the US Food & Drug Administration (USFDA) for its Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC). This approval allows Glenmark to expand its ophthalmic portfolio in the US market.

USFDA Approval and Market Potential

The newly approved product is bioequivalent to Pataday Once Daily Relief Ophthalmic Solution, 0.2% (OTC), developed by Alcon Laboratories, Inc. With this regulatory clearance, Glenmark Therapeutics Inc., USA, will commence distribution, strengthening its presence in the ophthalmic segment.

As per Nielsen syndicated data for the 52-week period ending 22 February 2025, the Pataday Once Daily Relief Ophthalmic Solution, 0.2% (OTC) market recorded annual sales of approximately $50.7 million. This positions Glenmark well to capitalise on the growing demand for over-the-counter ophthalmic treatments.

Commitment to OTC Ophthalmic Expansion

Marc Kikuchi, President & Business Head of North America at Glenmark, expressed confidence in the company’s expanding portfolio, stating, “We are pleased to continue to grow our OTC ophthalmic range. The addition of Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% underscores our commitment to meeting market needs and delivering quality over-the-counter solutions to customers.”

Glenmark Share Performance 

As of March 21, 2025, at 10:34 AM, Glenmark Pharma Ltd share price was trading at ₹1,500.00 per share, reflecting a surge of 1.43% from the previous day’s closing price. Over the past month, the stock has surged by 15.31%.

Conclusion

With this approval, Glenmark strengthens its foothold in the OTC ophthalmic space, bringing a cost-effective alternative to the US market. The move aligns with the company’s strategy to enhance accessibility to high-quality medications.

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