Lupin Secures FDA Approval for Generic Loteprednol Etabonate Ophthalmic Gel

Lupin has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Loteprednol Etabonate Ophthalmic Gel, 0.38%.

The approved formulation is the generic equivalent of Bausch & Lomb’s Lotemax SM Ophthalmic Gel and has been deemed bioequivalent. As the first generic filer, Lupin has secured 180 days of marketing exclusivity in the U.S. for this product. Manufacturing will take place at Lupin’s facility in Pithampur, India

Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid used to treat inflammation and pain following eye surgery. According to IQVIA MAT data as of May 2025, the reference product (Lotemax SM) recorded annual U.S. sales of approximately $29 million.