Lupin Limited secures FDA approval for generic Bromfenac Ophthalmic Solution

In a significant development for the global pharmaceutical industry, Lupin Limited (Lupin) has announced its latest achievement: receiving approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Bromfenac Ophthalmic Solution, 0.075%. This approval marks a pivotal step for Lupin, granting them the rights to manufacture and market a generic equivalent of BromSite Ophthalmic Solution, 0.075%, originally by Sun Pharmaceutical Industries Limited.

Lupin’s strategic milestone is underscored by its exclusive first-to-file status for this product, positioning the company at the forefront of generic medication production for this particular treatment. The Bromfenac Ophthalmic Solution, 0.075%, is specifically indicated for the treatment of postoperative inflammation and the prevention of ocular pain in patients undergoing cataract surgery—a common yet critical need in ophthalmic care.

The manufacturing of this newly approved generic solution will be carried out at Lupin’s state-of-the-art Pithampur facility in India, showcasing the company’s robust manufacturing capabilities and commitment to delivering high-quality pharmaceutical products globally. The approval of this generic version is not just a win for Lupin but represents a significant contribution to affordable healthcare, offering a cost-effective alternative to the branded BromSite Ophthalmic Solution.

Bromfenac Ophthalmic Solution 0.075% has been a notable product in the U.S. market, with estimated annual sales of USD 15 million (IQVIA MAT December 2023). Lupin’s entry into this market with a generic equivalent is expected to enhance the availability of this essential medication, ultimately benefiting patients undergoing cataract surgery by providing an effective solution for postoperative care and pain management.

The approval of Lupin’s Bromfenac Ophthalmic Solution by the U.S. FDA is a testament to the company’s innovation, quality, and dedication to addressing the unmet needs of patients worldwide. As the exclusive first-to-file for this product, Lupin sets a precedent in the generic pharmaceutical market, emphasizing the importance of accessible and affordable healthcare solutions. This approval not only strengthens Lupin’s portfolio but also reinforces its position as a leader in the global pharmaceutical industry, contributing to the broader goal of enhancing patient care and treatment outcomes in ophthalmology.