Mumbai: Global pharma major Lupin Limited has announced the launch of Bromfenac Ophthalmic Solution, 0.07%, after having received an approval from the United States Food and Drug Administration (U.S. FDA).
Lupin is the exclusive first-to-file for this product and is eligible for 180-day exclusivity.
Bromfenac Ophthalmic Solution, 0.07% is the generic equivalent of Prolensa Ophthalmic Solution, 0.07%, of Bausch & Lomb Inc. It is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
Bromfenac Ophthalmic Solution (RLD Prolensa) had estimated annual sales of USD 182 million in the U.S. (IQVIA MAT November 2023).
team had earlier reported that the Company had received approval from the USFDA for its Abbreviated New Drug Application for Loteprednol Etabonate Ophthalmic Suspension, 0.2%, to market a generic equivalent to the reference listed drug (RLD) Alrex Ophthalmic Suspension, 0.2%, of Bausch & Lomb Inc.
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Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
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The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers.
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