Pharma major Lupin Limited on Tuesday (July 1) announced that it has received approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for loteprednol etabonate ophthalmic gel, 0.38%.
The approved product is a generic version of Lotemax SM ophthalmic gel, 0.38%, originally developed by Bausch & Lomb Inc. Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity. This product will be manufactured at Lupin’s Pithampur facility in India.
Loteprednol etabonate ophthalmic gel, 0.38% is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. According to IQVIA MAT May 2025, loteprednol etabonate ophthalmic gel, 0.38% (RLD Lotemax SM) had an estimated annual sales of $29 million in the US.
Also Read: Lupin receives US FDA approval for drug used to treat bowel disorder
Last week, Lupin announced the launch of prucalopride tablets in the United States after receiving final approval from the FDA.
The tablets, used in the treatment of chronic idiopathic constipation (CIC) in adults, are available in 1 mg and 2 mg strengths and are bioequivalent to Motegrity tablets of Takeda Pharmaceuticals U.S.A., Inc.
According to IQVIA MAT data for April 2025, the estimated annual market size for prucalopride tablets in the US stands at $184 million. The drug will be manufactured at Lupin’s Goa facility, the company said in a stock exchange filing.
Shares of Lupin Ltd ended at ₹1,968, up by ₹30.20, or 1.56%, on the BSE.
Also Read: Lupin shares gain ahead of US drug launch that can fetch $200 million in FY26
