Lupin Shares Surge on USFDA Approval for Loteprednol Etabonate Ophthalmic Gel

n Limited’s share price rose following the U.S. Food and Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA) for Loteprednol Etabonate Ophthalmic Gel, 0.38%, announced on July 1, 2025. The gel, a generic equivalent to Bausch & Lomb’s Lotemax SM Ophthalmic Gel, is a corticosteroid used to treat post-operative inflammation and pain after ocular surgery. Lupin’s exclusive first-to-file status grants it 180 days of generic drug exclusivity in the U.S., with the product manufactured at its Pithampur facility in India. According to IQVIA (MAT May 2025), the gel has estimated annual U.S. sales of $29 million. On July 1, 2025, Lupin’s shares closed at ₹1,968, up 1.56% on the BSE.