1. Amneal's epinephrine injection approved by FDA for emergency treatments. 2. Includes single-dose and multi-dose presentations for hospitals. 3. Annual sales for epinephrine injections estimated at $118 million. 4. Expands Amneal's injectables portfolio, enhancing hospital supply access. 5. Reinforces commitment to affordable essential medicines in healthcare.
FDA approval and market potential indicate strong revenue growth potential for AMRX. Historical approvals in similar areas have shown immediate positive market response.
The FDA approval opens significant market opportunities and potential for increased sales, directly benefiting AMRX's future growth.
The new product will contribute to revenue over several years, particularly in the expanding healthcare sector.
BRIDGEWATER, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. ("Amneal" or the "Company") (NASDAQ:AMRX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's epinephrine injection USP, 1 mg/mL (1 mL), in single-dose vials and 1 mg/mL (30 mL) multi-dose vials. This medicine is a critical therapy utilized by hospitals, emergency departments and other acute care facilities for patient care.
"Epinephrine is one of the most important and widely used emergency medicines in healthcare," said Arash Dabestani, Pharm.D., Senior Vice President, Institutional. "By bringing both single- and multi-dose vial presentations to the institutional market, we are helping expand reliable and affordable access for hospitals and clinical providers, while reinforcing Amneal's commitment to supplying essential medicines that support patient care across the U.S. health system."
Epinephrine is a non-selective alpha and beta adrenergic agonist. The 1 mg/mL formulation is indicated for the emergency treatment of allergic reactions (Type 1) including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
The most common adverse reactions associated with systemically administered epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine but are more likely to occur in patients with heart disease, hypertension, or hyperthyroidism. For prescribing information, see package inserts for single dose vial here and multidose vial here.
According to IQVIA® U.S. annual sales for epinephrine injection single- and multi-dose vials for the 12 months ended October 2025 were approximately $118 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 290 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.
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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.
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VP, Investor Relations
anthony.dimeo@amneal.com
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Sr. Director, Corporate Communications
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