Lupin gains USFDA approval for Loteprednol Etabonate Ophthalmic Gel
Being the exclusive first-to-file, Lupin is eligible for 180-day generic exclusivity
Lupin announced that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Loteprednol Etabonate Ophthalmic Gel, 0.38 per cent. Loteprednol Etabonate Ophthalmic Gel, 0.38 per cent is bioequivalent to Lotemax SM Ophthalmic Gel of Bausch & Lomb. Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity. This product will be manufactured at Lupin’s Pithampur facility in India.
Loteprednol Etabonate Ophthalmic Gel, 0.38 per cent is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery.
Loteprednol Etabonate Ophthalmic Gel, 0.38 per cent (RLD Lotemax SM) had an estimated annual sale of $ 29 million in the U.S. (IQVIA MAT May 2025).