Lupin gets U.S. FDA nod for Loteprednol Etabonate Ophthalmic Gel

Generic drugmaker Lupin has received U.S. Food and Drug Administration approval for its abbreviated new drug application for Loteprednol Etabonate Ophthalmic Gel, 0.38%

The approved product is bioequivalent to Lotemax SM Ophthalmic Gel of Bausch & Lomb Inc. Lupin is the exclusive first-to-file for the product and consequently eligible for 180 days of generic drug exclusivity. The product will be manufactured at its Pithampur facility, the company said.

Loteprednol Etabonate Ophthalmic Gel, 0.38% (RLD Lotemax SM) had an estimated annual sale of $29 million in the U.S., it said citing IQVIA MAT May 2025 numbers. A corticosteroid, the drug is indicated for treatment of postoperative inflammation and pain following ocular surgery.