Lupin Secures Tentative U.S. FDA Approval For Brimonidine Tartrate Ophthalmic Solution

Lupin, a global pharmaceutical company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Brimonidine Tartrate Ophthalmic Solution, 0.025 per cent (OTC).

The company in a press statement on Thursday , informed that this approval paves the way for Lupin to market a generic version of Lumify Ophthalmic Solution, 0.025 per cent, originally developed by Bausch & Lomb Incorporated.

The tentative approval marks a significant step for Lupin, as the Brimonidine Tartrate Ophthalmic Solution will be manufactured at its state-of-the-art facility in Pithampur, India. This solution is used for relieving eye redness caused by minor irritations, providing a cost-effective alternative for consumers.

Brimonidine Tartrate Ophthalmic Solution (RLD Lumify) has an estimated annual sale of USD 39 million in the U.S., according to IQVIA MAT data as of June 2024. Lupin's entry into this market is expected to offer a more affordable option for patients and contribute to the company's growth in the ophthalmic segment.

This tentative approval is part of Lupin's ongoing commitment to expanding its portfolio of high-quality, affordable generic medications in the U.S. market. The final approval and subsequent launch of this product will depend on the expiration of any existing patents or exclusivities.