Amneal Receives U.S. FDA Approval for Prednisolone Acetate Ophthalmic Suspension

Rhea-AI Summary

Amneal Pharmaceuticals (AMRX) has received FDA approval for prednisolone acetate ophthalmic suspension, 1% sterile, a generic version of Pred Forte®. The product, a sterile topical anti-inflammatory agent for ophthalmic use, is designed to treat steroid-responsive ocular inflammation. Amneal plans to launch the product in Q3 2025. This approval represents a significant addition to Amneal's Affordable Medicines portfolio, demonstrating the company's R&D and manufacturing capabilities in complex products. According to IQVIA® data, the U.S. annual sales for prednisolone acetate ophthalmic suspension reached approximately $201 million for the 12 months ended April 2025.

Positive

• FDA approval received for a complex generic product with $201 million market opportunity
• Planned commercial launch in Q3 2025 expanding Affordable Medicines portfolio
• Demonstrates company's advanced R&D and manufacturing capabilities in complex products

Negative

• Product carries risks including possible glaucoma development and optic nerve damage
• Potential delayed wound healing and cataract formation as adverse effects

Insights

Pharmaceutical Industry Analyst

Amneal's FDA approval for generic Pred Forte adds meaningful revenue potential from a $201M market with complex manufacturing barriers.

Amneal has secured FDA approval for prednisolone acetate ophthalmic suspension 1%, a generic version of AbbVie's Pred Forte. This approval represents a significant win for Amneal's Affordable Medicines segment, especially considering the $201 million annual market size according to IQVIA data.

What makes this approval particularly valuable is the complexity factor. Ophthalmic suspensions are notoriously challenging to develop and manufacture compared to standard oral generics. These products require specialized manufacturing capabilities, precise particle size control, and stringent sterility measures. This complexity creates a higher barrier to entry, potentially limiting competition and preserving better margins than typical generic products.

The Q3 2025 launch timeline indicates Amneal has manufacturing capacity ready to support commercialization. This approval strengthens Amneal's ophthalmology portfolio, an attractive therapeutic area due to its specialized nature and generally favorable economics compared to highly commoditized generic segments.

For context, prednisolone acetate ophthalmic suspension is a corticosteroid used to treat inflammatory eye conditions. Its approval adds a widely-prescribed product to Amneal's lineup while demonstrating the company's R&D capabilities in handling complex formulations. The $201 million market opportunity represents a meaningful revenue addition for Amneal, whose total annual revenue is approximately $2.4 billion.

• Key complex product approval in the Affordable Medicines segment this year
• Commercial launch planned for third quarter of 2025

BRIDGEWATER, N.J., June 12, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of prednisolone acetate ophthalmic suspension, 1% sterile which references Pred Forte^®. Pred Forte and its design are trademarks of Allergan, Inc., an AbbVie company. Launch of this product is planned for the third quarter of 2025.

Prednisolone acetate ophthalmic suspension, USP 1% is a sterile, topical anti-inflammatory agent for ophthalmic use and is indicated for treating steroid-responsive ocular inflammation.

“Our Affordable Medicines portfolio continues to grow with a strong and diverse pipeline that supports broader access to high-quality treatments across the U.S. healthcare system,” said Andy Boyer, Executive Vice President and Chief Commercial Officer, Affordable Medicines. “The approval of prednisolone acetate ophthalmic suspension—a complex product to develop and manufacture—highlights the depth of our R&D capabilities and the strength of our manufacturing and supply operations.”

The most commonly reported adverse reactions for prednisolone acetate ophthalmic suspension in clinical studies were elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing. For prescribing information, see package insert here.

According to IQVIA^® U.S. annual sales for prednisolone acetate ophthalmic suspension for the 12 months ended April 2025 were approximately $201 million.

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 prednisolone acetate ophthalmic suspension that AMRX will enter?

According to IQVIA data, the U.S. annual sales for prednisolone acetate ophthalmic suspension were approximately $201 million for the 12 months ended April 2025.

When will Amneal Pharmaceuticals launch its newly approved prednisolone acetate ophthalmic suspension?

Amneal plans to launch the product in the third quarter of 2025.

What are the main side effects of Amneal's prednisolone acetate ophthalmic suspension?

The most common adverse reactions include elevated intraocular pressure potentially leading to glaucoma, optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.

What is the primary use of AMRX's newly approved prednisolone acetate ophthalmic suspension?

It is a sterile, topical anti-inflammatory agent for ophthalmic use, indicated for treating steroid-responsive ocular inflammation.

What percentage strength is Amneal's approved prednisolone acetate ophthalmic suspension?

The approved product is a 1% sterile suspension.