Amneal Secures U.S. FDA Approval For 0.01% Bimatoprost Ophthalmic Solution

Amneal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for bimatoprost ophthalmic solution 0.01% in 2.5 mL, 5 mL, and 7.5 mL sizes. The product is the generic equivalent of LUMIGAN® 0.01%, a trademarked formulation by Allergan, Inc., an AbbVie company. Bimatoprost ophthalmic solution 0.01% is a prostaglandin analog used to lower elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. 

Dr. Srinivas Kone, Senior Vice President and Chief Scientific Officer – Affordable Medicines, highlighted that this approval expands Amneal’s Affordable Medicines portfolio and provides patients and healthcare providers with more accessible treatment options, especially as glaucoma prevalence rises in the aging population. He also noted that this approval represents one of the company’s complex new product approvals this year and a significant growth driver for the Affordable Medicines segment. 

The most common adverse reaction associated with bimatoprost ophthalmic solution 0.01% is conjunctival hyperemia. According to IQVIA®, U.S. annual sales of bimatoprost ophthalmic solution 0.01% for the 12 months ending July 2025 were approximately $685 million.