LUMIGAN® (bimatoprost ophthalmic solution) 0.01%
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Amneal Receives U.S. FDA Approval for Bimatoprost Ophthalmic Solution, 0.01%
Globenewswire· 2025-09-23 12:00
Core Insights - Amneal Pharmaceuticals has received FDA approval for its Abbreviated New Drug Application (ANDA) for bimatoprost ophthalmic solution 0.01%, a generic equivalent of LUMIGAN® [1][4] - Bimatoprost is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension [2] - The approval is part of Amneal's strategy to expand its Affordable Medicines portfolio, addressing the rising prevalence of glaucoma, especially among the aging population [3] Financial Impact - The annual sales for bimatoprost ophthalmic solution 0.01% were approximately $685 million for the 12 months ending July 2025 [4] Company Overview - Amneal Pharmaceuticals is a global biopharmaceutical company based in Bridgewater, NJ, with a diverse portfolio of over 280 pharmaceuticals [5] - The company is expanding its Affordable Medicines segment across various complex product categories, including injectables and biosimilars [5]