Amneal Launches Generic Dexamethasone Following ANDA Approval by FDA

Rhea-AI Summary

Amneal Pharmaceuticals (NYSE: AMRX) has announced the launch of dexamethasone in 4mg and 6mg formulations following FDA approval. This glucocorticoid steroid is crucial for treating various conditions, including COVID-19 complications. The U.S. market for these dexamethasone tablets reached approximately $63 million in annual sales as of August 2021. The company emphasizes its commitment to expanding access to essential therapies while recognizing potential risks, including HPA axis suppression and contraindications for allergic patients.

Positive

• Launch of dexamethasone tablets enhances Amneal's product portfolio.
• FDA approval marks a significant regulatory milestone.
• Potential market opportunity with annual sales of approximately $63 million.

Negative

• Dexamethasone use may lead to serious side effects, including HPA axis suppression.
• Contains contraindications for patients allergic to its components.

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that it is launching dexamethasone, 4mg and 6 mg, following Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA).

Dexamethasone, the generic version of Decadron®, is a well-established anti-inflammatory glucocorticoid steroid used to treat several medical conditions, including respiratory complications associated with COVID-19.

“Today’s approval and launch of dexamethasone reflects the continued execution of our innovation agenda. Expanding access to essential therapies, particularly in the treatment of COVID-19, is core to our mission at Amneal and we are pleased to play our part,” said Chirag and Chintu Patel, Co-Chief Executive Officers.

According to IQVIA™, a leading healthcare data and analytics provider, U.S. annual sales for 4 mg and 6 mg dexamethasone tablets for the 12 months ended August 2021 were approximately $63 million.

Dexamethasone tablets can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Elevated blood pressure, sodium and water retention, and increased excretion of potassium, have also been reported.

Mild to severe infection with exacerbation may occur with the use of dexamethasone tablets alone or in combination with other immunosuppressive agents. Dexamethasone is contraindicated in patients hypersensitive to any components of this product.

See Package Insert (PI) for full prescribing information including Safety Information: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ac71f888-c83a-46a5-921c-1ebdf6cfadc1&type=display

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully-integrated pharmaceutical company focused on the development, manufacturing and distribution of generic and specialty drug products. The Company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.

Amneal has an extensive portfolio of approximately 250 product families and is expanding its portfolio to include complex dosage forms, including biosimilars, in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system and endocrine disorders.

The Company also owns 65% of AvKARE. AvKARE provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, primarily focused on serving the Department of Defense and the Department of Veterans Affairs. AvKARE is also a packager and wholesale distributor of pharmaceuticals and vitamins to its retail and institutional customers who are located throughout the United States focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing. For more information, 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 and make acquisitions of 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; 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/20211027005168/en/

Anthony DiMeo

Senior Director, Investor Relations

anthony.dimeo@amneal.com

Source: Amneal Pharmaceuticals, Inc.

FAQ

What recent product did Amneal Pharmaceuticals launch?

Amneal Pharmaceuticals launched dexamethasone in 4mg and 6mg after FDA approval.

What is the market potential for dexamethasone tablets?

The U.S. market for dexamethasone tablets was approximately $63 million in annual sales as of August 2021.

What are the safety concerns associated with dexamethasone tablets?

Dexamethasone may cause HPA axis suppression and is contraindicated in patients allergic to its components.

How does the FDA approval affect Amneal Pharmaceuticals' stock?

FDA approval may positively impact Amneal's stock by expanding its product offerings and market presence.