In a significant milestone for Indian pharma major Lupin Limited, the company has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Loteprednol Etabonate Ophthalmic Gel, 0.38%, a generic equivalent of Lotemax® SM Ophthalmic Gel by Bausch & Lomb.

This approval not only expands Lupin’s growing ophthalmic portfolio but also grants the company exclusive first-to-file rights, enabling it to enjoy 180 days of generic market exclusivity in the United States—a key competitive edge in the highly regulated and competitive U.S. generics space.

Manufactured at Lupin’s state-of-the-art facility in Pithampur, India, the product is a corticosteroid used to treat postoperative inflammation and pain following ocular surgery, a critical need area in post-operative eye care.

According to IQVIA MAT data (May 2025), the reference product Lotemax® SM had estimated annual U.S. sales of USD 29 million, presenting a meaningful revenue opportunity for Lupin during the exclusivity window.

Commenting on the development, a Lupin spokesperson said, “Securing exclusive rights to a high-quality ophthalmic generic reinforces our commitment to bringing affordable, accessible therapies to global markets. This approval strengthens our specialty pipeline and showcases our R&D and regulatory execution capabilities.”

The development marks another feather in Lupin’s cap as it continues to deepen its presence in the U.S. pharmaceuticals market, especially in the niche and complex generics segment, where exclusivity periods can significantly enhance profitability and market position.

With this move, Lupin not only reinforces its stature as a trusted global pharmaceutical player but also contributes to improving patient access to critical post-operative treatments at significantly reduced costs.

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