Lupin Launches Bromfenac Ophthalmic Solution in the US, Securing 180-Day Exclusivity

10 Jan 2024 , 01:57 PM

Lupin officially launches bromfenac ophthalmic solution, 0.07%, in the United States following FDA approval.

The company holds exclusive first-to-file status, granting a 180-day exclusivity period for the newly-introduced product.

Bromfenac ophthalmic solution is the generic equivalent of Prolensa® Ophthalmic Solution, 0.07%, by Bausch & Lomb Inc., indicated for postoperative inflammation and ocular pain reduction after cataract surgery.

The product represents a substantial market opportunity for Lupin, with estimated annual sales of $182 million in the US as of November 2023 (IQVIA MAT data).

Lupin operates globally, developing and commercializing a diverse range of branded and generic formulations, biotechnology products, and APIs in over 100 markets.

The company boasts 15 manufacturing sites, seven research centers, and a global workforce of over 20,000 professionals, serving regions such as the US, India, South Africa, Asia Pacific, Latin America, Europe, and the Middle East.

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