Amneal Begins Supplying Over-the-Counter Naloxone Hydrochloride Nasal Spray to U.S. Retail Pharmacies and the State of California

Published 7 months ago via Business Wire

Significantly expanding access to affordable, life-saving opioid overdose rescue medicine

Entered distribution agreement with California; actively engaging with other states and municipalities to expand access

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that it has begun supplying its over-the-counter (OTC) Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, USP, 4mg to U.S. retail pharmacies and the State of California. The product is now available for direct distribution to states and municipalities across the U.S.

The U.S. Food and Drug Administration approved Amneal’s Naloxone HCI Nasal Spray in April 2024. Amneal’s Naloxone HCI Nasal Spray is a generic equivalent to OTC NARCAN® HCI Nasal Spray, a medication widely used to help treat opioid drug overdoses. The Company also entered into a distribution agreement with California to provide Naloxone HCI Nasal Spray through the CalRx® Naloxone Access Initiative. Amneal expects to have capacity to produce approximately ten million two-packs annually at its New Jersey manufacturing facility, starting in 2025.

“Amneal is an industry leader in complex generics with the ability to develop, manufacture and commercialize high-quality medicines that are affordable and accessible. The widespread availability of OTC naloxone will be a critical tool in the fight against the ongoing opioid epidemic. Amneal is proud to be part of the solution,” said Andy Boyer, Executive Vice President, Chief Commercial Officer – Generics.

“We are pleased to partner with the State of California on a long-term distribution agreement to make OTC naloxone available to thousands of communities and millions of people. We are actively engaging with other states and municipalities to expand access to this important life-saving product, which is proudly made in America in one of our New Jersey facilities,” said Maryll Toufanian, SVP, Regulatory Strategy and Government Affairs.

To learn more about Amneal’s Naloxone HCl Nasal Spray, please visit https://amnealnaloxone.com/.

About Naloxone Nasal Spray

Naloxone Hydrochloride (Naloxone HCI) Nasal Spray is designed to rapidly reverse the effects of a life-threatening opioid emergency by binding to opioid receptors in the brain and blocking the effects of opioids. It can restore normal breathing within two to three minutes in a person whose breath has slowed, or even stopped, as a result of an overdose from opioids including heroin, fentanyl and prescription opioid medications. Amneal’s Naloxone HCI Nasal Spray contains the same active ingredient and dose as NARCAN® Naloxone HCI Nasal Spray, 4 mg. It is available over-the-counter and is easy to carry, and it can be safely used even if opioids are not present in the patient.

NARCAN® is a registered trademark of Emergent Operations Ireland Limited.

When using this product some people may experience symptoms when they wake up, such as shaking, sweating, nausea or feeling angry. This is to be expected.

About Amneal

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceutical products, primarily within the United States. In its Generics 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, with a pipeline focused on unmet needs. 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.

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