Amneal Receives Approval for Difluprednate Ophthalmic Emulsion

Rhea-AI Summary

Amneal Pharmaceuticals (NYSE: AMRX) has received FDA approval for its generic ophthalmic product, difluprednate ophthalmic emulsion 0.05%, a substitute for Durezol®, used to treat pain and inflammation from ocular surgery. This product marks a strategic shift towards more complex offerings in Amneal's portfolio. The annual sales for Durezol® and generics stand at approximately $103 million as of September 2021. However, potential side effects include increased risks of cataracts and glaucoma.

Positive

• FDA approval for difluprednate expands product offerings.
• Strategic shift towards more complex and differentiated products.
• Access to a market generating approximately $103 million in annual sales.

Negative

• Difluprednate may lead to severe side effects like cataracts and glaucoma.
• Risks associated with prolonged use include optic nerve damage and delayed healing.

- Represents the latest generic ophthalmic product approval for Amneal

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for difluprednate ophthalmic emulsion 0.05%, which is the generic version of Durezol® and is used in the treatment of inflammation and pain associated with ocular surgery.

“With the approval of difluprednate, a complex ophthalmic suspension product, we continue to shift our portfolio to increasingly complex and more differentiated product areas. The wheel of innovation constantly turns at Amneal, and we see a long runway for our R&D engine,” said Chirag and Chintu Patel, Co-Chief Executive Officers.

According to IQVIA®, U.S. annual sales for Durezol® and its generic equivalents in the 12 months ended September 2021 were approximately $103 million.

Difluprednate Ophthalmic Emulsion, 0.05%, as with other ophthalmic corticosteroids, may result in posterior subcapsular cataract formation; increase the hazard of secondary ocular infections, and delay healing with the increase in the incidence of bleb formation. Glaucoma can also result from prolonged use, with damage to the optic nerve, defects in visual acuity, and fields of vision. Difluprednate use is contraindicated in fungal disease of ocular structures; viral diseases of the cornea and conjunctiva; and Mycobacterial infection of the eye. Reported adverse drug reactions include blepharitis; conjunctival edema; corneal edema; posterior capsule opacification; anterior chamber flare; ciliary and conjunctival hyperemia; anterior chamber cells; and eye pain.

See Package Insert (PI) for full prescribing information including Safety Information: https://www.amneal.com/wp-content/uploads/2021/11/Amneal-Difluprednate-ophthalmic-emulsion-PI-Rev-10-2020-01.pdf

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals, primarily within the United States. The Company has a diverse portfolio of approximately 250 products in its Generics business and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars. In its Specialty business, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE business, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more, please visit www.amneal.com.

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 or forecasts for the future, including among other things: discussions of future operations; expected operating results and financial performance; impact of planned acquisitions and dispositions; the Company’s strategy for growth; product development; regulatory approvals; market position and expenditures. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates” and similar words are intended to identify estimates and forward-looking statements.

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company.

Such risks and uncertainties include, but are not limited to: the impact of the COVID-19 pandemic; the impact of global economic conditions; our ability to successfully develop, license, acquire and commercialize new products on a timely basis; our ability to obtain exclusive marketing rights for our products; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to manage our growth through acquisitions and otherwise; our dependence on the sales of a limited number of products for a substantial portion of our total revenues; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to FDA product approval requirements; risks related to federal regulation of arrangements between manufacturers of branded and generic products; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; the continuing trend of consolidation of certain customer groups; our reliance on certain licenses to proprietary technologies from time to time; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; our dependence on third-party agreements for a portion of our product offerings; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; the significant amount of resources we expend on research and development; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; the impact of severe weather; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. 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. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211119005221/en/

Anthony DiMeo

Senior Director, Investor Relations

anthony.dimeo@amneal.com

Source: Amneal Pharmaceuticals, Inc.

FAQ

What recent approval did Amneal Pharmaceuticals receive for AMRX?

Amneal Pharmaceuticals received FDA approval for difluprednate ophthalmic emulsion 0.05%, a generic version of Durezol®.

What is the market potential for difluprednate for Amneal?

The annual sales for Durezol® and its generics were approximately $103 million as of September 2021.

What are the risks associated with difluprednate use?

Potential risks include cataract formation, glaucoma, and delayed wound healing.