FDA Approves Amneal Pharmaceuticals’ Generic Bimatoprost 0.01% for Glaucoma and Ocular Hypertension

Amneal Pharmaceuticals has received FDA approval for its Abbreviated New Drug Application (ANDA) for bimatoprost ophthalmic solution 0.01%, marking the company’s latest addition to its Affordable Medicines portfolio. The generic product is approved in 2.5 mL, 5 mL, and 7.5 mL volumes and is a therapeutic equivalent to LUMIGAN, used for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

FDA Greenlights Generic Version of LUMIGAN

The approval from the U.S. Food and Drug Administration (FDA) enables Amneal to manufacture and market bimatoprost ophthalmic solution 0.01%, a prostaglandin analog indicated to reduce IOP. The decision was granted through the Abbreviated New Drug Application (ANDA) pathway, which facilitates the approval of generic versions of already approved drugs by eliminating the need for extensive clinical and preclinical trials.

Addressing Access to Glaucoma Therapies Through Generic Alternatives

“We are pleased to add another key ophthalmic therapy to our Affordable Medicines portfolio,” said Srinivas Kone, PhD, Senior Vice President and Chief Scientific Officer at Amneal.
“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.”

Amneal’s Affordable Medicines segment spans multiple complex product categories, including injectables and biosimilars, with a focus on expanding access to essential treatments across diverse therapeutic areas.

The bimatoprost approval follows another key ophthalmic development for Amneal. In June 2025, the FDA also approved the company’s prednisolone acetate ophthalmic suspension, a topical anti-inflammatory agent used in the treatment of steroid-responsive ocular inflammation, referencing Pred Forte. The commercial launch of this product in the U.S. is expected in Q3 2025.