Lupin receives FDA approval for Loteprednol Etabonate Ophthalmic Gel, 0.38%

Lupin Limited recently announced the US Food and Drug Administration (FDA) approval for the company’s Abbreviated New Drug Application for Loteprednol Etabonate Ophthalmic Gel, 0.38%.¹

Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid for the treatment of postoperative inflammation and pain following ocular surgery. It is the bioequivalent to Bausch & Lomb’s Lotemax SM Ophthalmic Gel. Additionally, Loteprednol Etabonate Ophthalmic Gel, 0.38% had an estimated annual sale of $29 million in the US, according to a press release.

Lupin is eligible for 180 days of drug exclusivity, as the company is the exclusive first-to-file for the product.

Reference:

1. kw2023. Lupin and Sino Universal Pharmaceuticals Sign License and Supply Agreement for Tiotropium DPI in China. Lupin. Published July 2025. Accessed July 1, 2025. https://www.lupin.com/lupin-receives-approval-from-u-s-fda-for-loteprednol-etabonate-ophthalmic-gel/