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

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Key Takeaways

Lupin's Loteprednol Etabonate Ophthalmic Gel, 0.38% is FDA-approved for treating postoperative ocular inflammation and pain.
The gel is bioequivalent to Bausch & Lomb’s Lotemax SM Ophthalmic Gel, with $29 million in annual US sales.
Lupin gains 180 days of drug exclusivity as the exclusive first-to-file, enhancing market competitiveness.

Lupin Limited secures FDA approval for Loteprednol Etabonate Ophthalmic Gel, enhancing treatment options for postoperative ocular inflammation and pain.

(Image Credit: AdobeStock)

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:

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/

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