Lupin Limited has informed the Exchange regarding a press release dated July 01, 2025, titled "Lupin Receives Approval from U.S. FDA for Loteprednol Etabonate Ophthalmic Gel".
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Lupin has received approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Loteprednol Etabonate Ophthalmic Gel, 0.38%, used to treat post-operative inflammation and pain after eye surgery. The product is a generic version of Bausch & Lomb's Lotemax SM Ophthalmic Gel. Lupin is the exclusive first-to-file applicant, making it eligible for 180 days of generic drug exclusivity in the U.S. market. The reference brand had estimated annual U.S. sales of USD 29 million (IQVIA MAT May 2025). The product will be manufactured at Lupin's Pithampur facility in India.
This is a positive development for Lupin shareholders. The 180-day exclusivity allows Lupin to be the sole generic supplier for six months, potentially capturing the full USD 29 million market. It also strengthens Lupin's U.S. ophthalmology portfolio and pipeline execution credibility.