Lupin announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its abbreviated new drug application (ANDA) for Loteprednol Etabonate Ophthalmic Gel, 0.38%.
The product is a generic equivalent of Lotemax SM Ophthalmic Gel, 0.38%, marketed by Bausch & Lomb Inc.
Lupin is the exclusive first-to-file applicant for this product and is eligible for 180 days of generic drug exclusivity. The product will be manufactured at Lupins Pithampur facility in India.
Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery.
According to IQVIA MAT data for May 2025, Loteprednol Etabonate Ophthalmic Gel, 0.38% (Reference Listed Drug: Lotemax SM) had estimated annual sales of $29 million in the U.S.
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Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
The companys consolidated net profit surged 114.9% to Rs 772.52 crore on a 13.6% jump in net sales to Rs 5,562.20 crore in Q4 FY25 over Q4 FY24.
The scrip rose 0.85% to Rs 1,978.05 on the BSE.
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