Lupin Launches Generic Bromfenac Ophthalmic Solution in the US

Lupin Limited announced the launch of Bromfenac Ophthalmic Solution, 0.075%. The product has received the green light from the United States Food and Drug Administration (U.S. FDA), marking a crucial milestone for the company's expansion in the American pharmaceutical market.

Bromfenac Ophthalmic Solution, 0.075%, stands as a generic alternative to BromSite® Ophthalmic Solution, 0.075%, developed by Sun Pharmaceutical Industries Limited. This latest offering from Lupin is designed to address postoperative inflammation and prevent ocular pain in individuals undergoing cataract surgery, catering to the medical needs of a significant patient population.

The approval from the U.S. FDA underscores the rigorous testing and adherence to quality standards that Lupin upholds in its pharmaceutical development processes. By introducing this generic equivalent, Lupin aims to provide accessible and affordable healthcare solutions without compromising on efficacy or safety.

Bromfenac Ophthalmic Solution 0.075% (RLD BromSite®) has exhibited substantial market potential, with estimated annual sales reaching USD 15 million in the U.S. as per IQVIA MAT December 2023 data. Lupin's entry into this segment is poised to create a competitive landscape that fosters innovation and cost-effective treatment options for patients.