Amneal Receives U.S. FDA Approval for Bimatoprost Ophthalmic Solution, 0.01%

Rhea-AI Summary

Amneal Pharmaceuticals (NYSE:AMRX) has received FDA approval for its generic version of bimatoprost ophthalmic solution 0.01%, equivalent to LUMIGAN®. The treatment, indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, represents a significant addition to Amneal's Affordable Medicines portfolio.

The approval covers multiple sizes (2.5 mL, 5 mL and 7.5 mL) of the solution. According to IQVIA® data, the reference product generated approximately $685 million in U.S. annual sales for the 12 months ended July 2025, highlighting substantial market opportunity for Amneal.

Positive

• FDA approval received for generic version of LUMIGAN® with $685M market opportunity
• Product will be key growth driver for Amneal's Affordable Medicines segment
• Multiple product sizes approved (2.5 mL, 5 mL and 7.5 mL) offering flexibility in treatment options

Negative

• Most common adverse reaction reported is conjunctival hyperemia

News Market Reaction

-1.60%

1 alert

-1.60% News Effect

-$51M Valuation Impact

$3.14B Market Cap

4K Volume

On the day this news was published, AMRX declined 1.60%, reflecting a mild negative market reaction. This price movement removed approximately $51M from the company's valuation, bringing the market cap to $3.14B at that time.

Data tracked by StockTitan Argus on the day of publication.

Important ophthalmic treatment for patients and expected to be a key growth driver for Amneal’s Affordable Medicines segment

BRIDGEWATER, N.J., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Abbreviated New Drug Application (ANDA) for bimatoprost ophthalmic solution 0.01% (2.5 mL, 5 mL and 7.5 mL). The product is the generic equivalent of LUMIGAN^® (bimatoprost ophthalmic solution) 0.01%, whose design is a trademark of Allergan, Inc., an AbbVie company.

Bimatoprost ophthalmic solution 0.01% is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

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

The most common adverse reaction associated with bimatoprost ophthalmic solution 0.01% is conjunctival hyperemia. For prescribing information, see package insert here.

According to IQVIA^® U.S. annual sales for bimatoprost ophthalmic solution 0.01% for the 12 months ended July 2025 were approximately $685 million.

Note: LUMIGAN^® is a registered trademark of Allergan, Inc., an AbbVie company.

About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn.

Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

Investor Contact
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com

Media Contact
Brandon Skop
Sr. Director, Corporate Communications
brandon.skop@amneal.com

FAQ

What is the market size for Amneal's newly approved bimatoprost ophthalmic solution?

According to IQVIA® data, the U.S. annual sales for bimatoprost ophthalmic solution 0.01% were approximately $685 million for the 12 months ended July 2025.

What is Amneal's (AMRX) bimatoprost ophthalmic solution used to treat?

The solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

What sizes are available for Amneal's newly approved bimatoprost ophthalmic solution?

The FDA approval covers three sizes: 2.5 mL, 5 mL and 7.5 mL of the ophthalmic solution.

What is the main side effect of Amneal's bimatoprost ophthalmic solution?

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

Which drug is Amneal's bimatoprost ophthalmic solution generic to?

The product is the generic equivalent of LUMIGAN® (bimatoprost ophthalmic solution) 0.01%, whose design is a trademark of Allergan, Inc., an AbbVie company.