Lupin Secures USFDA Nod For Loteprednol Gel With Market Exclusivity

Lupin Ltd. said it has received final approval from the US Food and Drug Administration for its abbreviated new drug application for Loteprednol Etabonate ophthalmic gel, a generic version of Bausch & Lomb Inc.’s Lotemax gel. Lupin is the exclusive first-to-file applicant and will enjoy 180 days of marketing exclusivity in the US.

The product, used to treat postoperative inflammation and pain following eye surgery, will be manufactured at Lupin’s Pithampur facility in Madhya Pradesh. It has estimated annual sales of $29 million in the US, the company said in an exchange filing.