FDA approves Amneal’s generic bimatoprost for glaucoma treatment

Published 23/09/2025, 13:06
FDA approves Amneal’s generic bimatoprost for glaucoma treatment

BRIDGEWATER, N.J. - Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX), a pharmaceutical company with a market capitalization of $3.14 billion and showing strong year-to-date returns of 26%, announced Tuesday that the U.S. Food and Drug Administration has approved its Abbreviated New Drug Application for bimatoprost ophthalmic solution 0.01%, a generic version of Allergan’s Lumigan.

The medication, available in 2.5 mL, 5 mL, and 7.5 mL sizes, is used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

"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," said Dr. Srinivas Kone, Senior Vice President and Chief Scientific Officer for Affordable Medicines at Amneal.

According to IQVIA data cited in the company’s press release, U.S. annual sales for bimatoprost ophthalmic solution 0.01% reached approximately $685 million for the 12 months ended July 2025. InvestingPro data shows Amneal’s revenue growth at 9.81% over the last twelve months, with analysts expecting continued net income growth this year.

The most common adverse reaction associated with the medication is conjunctival hyperemia, according to the company.

This approval adds to Amneal’s portfolio of over 280 pharmaceutical products. The company describes the new generic as an important growth driver for its Affordable Medicines segment and notes it represents its most recent complex new product approval this year.

Amneal Pharmaceuticals is headquartered in Bridgewater, New Jersey, and focuses on the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The company maintains a "GREAT" financial health score according to InvestingPro analysis, which offers comprehensive insights through its Pro Research Report, available along with 8 additional ProTips and detailed financial metrics for subscribers.

In other recent news, Amneal Pharmaceuticals reported its Q2 2025 earnings, revealing a significant earnings per share (EPS) performance that exceeded expectations. The company achieved an EPS of $0.25, surpassing the anticipated $0.17, representing a 47.06% surprise. However, Amneal’s revenue fell short of projections, totaling $725 million compared to the expected $748.18 million. In addition to its earnings report, Amneal Pharmaceuticals announced that the U.S. Food and Drug Administration has approved its risperidone extended-release injectable suspension. This medication is a generic version of Janssen’s Risperdal Consta and is used for schizophrenia treatment and maintenance therapy for Bipolar I disorder. These developments reflect the company’s ongoing efforts to expand its product offerings and address key market needs.

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