Amneal Pharmaceuticals Gains FDA Approval for Generic Bimatoprost Ophthalmic Solution 0.01%

Amneal Pharmaceuticals announced that the FDA has approved its abbreviated new drug application (ANDA) for bimatoprost ophthalmic solution 0.01%. The product will be available in 2.5 mL, 5 mL, and 7.5 mL bottles and is the generic equivalent of Lumigan (bimatoprost ophthalmic solution; Allergan) 0.01%.

Bimatoprost ophthalmic solution 0.01% is a prostaglandin analog indicated for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension. These conditions, if left untreated, can lead to progressive optic nerve damage and vision loss.

“As the prevalence of glaucoma continues to rise, particularly among the aging population, it is critical that patients and providers have affordable access to effective treatments such as bimatoprost. This represents our most recent complex new product approval this year and an important growth driver for our Affordable Medicines segment," said Dr. Srinivas Kone, Senior Vice President and Chief Scientific Officer–Affordable Medicines.

According to IQVIA, US annual sales for bimatoprost ophthalmic solution 0.01% totaled approximately $685 million for the 12 months ended July 2025.

The most common adverse reaction observed with bimatoprost ophthalmic solution 0.01% is conjunctival hyperemia.