Amneal Supplies OTC Naloxone Nasal Spray to U.S. Pharmacies and California

Amneal Pharmaceuticals, Inc. has announced that it has started supplying its over-the-counter (OTC) Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, USP, 4mg, to U.S. retail pharmacies and the State of California. This initiative is part of a broader effort to make the life-saving opioid overdose rescue medicine more accessible to communities across the United States. The product, which received approval from the U.S. Food and Drug Administration (FDA) in April 2024, is a generic alternative to OTC NARCAN® HCI Nasal Spray, a widely-used medication for opioid overdoses.

Amneal has entered into a distribution agreement with the State of California to provide Naloxone HCI Nasal Spray under the CalRx® Naloxone Access Initiative. This partnership aims to ensure that the medication reaches numerous communities and millions of residents in California. Furthermore, the company is actively engaging with other states and municipalities to expand access across the country. Amneal plans to produce around ten million two-packs of the spray annually at its New Jersey manufacturing facility starting in 2025.

Andy Boyer, Executive Vice President and Chief Commercial Officer for Generics at Amneal, emphasized the company's leadership in complex generics and its commitment to making high-quality, affordable medicines available. He highlighted the importance of OTC naloxone in combating the opioid epidemic, expressing pride in Amneal's role in providing a solution.

Maryll Toufanian, Senior Vice President of Regulatory Strategy and Government Affairs at Amneal, expressed satisfaction with the long-term agreement with California. She noted that the company is working with other states and municipalities to broaden the availability of the life-saving product, which is manufactured in the United States.

Naloxone Hydrochloride (Naloxone HCI) Nasal Spray is designed to quickly reverse the effects of a life-threatening opioid overdose. It works by binding to opioid receptors in the brain, effectively blocking the effects of opioids. The spray can restore normal breathing within two to three minutes in individuals whose breathing has slowed or stopped due to an opioid overdose, including from substances like heroin, fentanyl, and prescription opioid medications. Amneal's Naloxone HCI Nasal Spray contains the same active ingredient and dosage as NARCAN® Naloxone HCI Nasal Spray, 4 mg. It is available OTC, easy to carry, and safe to use even if opioids are not present in the person's system.

Amneal Pharmaceuticals, Inc., headquartered in Bridgewater, New Jersey, is a global pharmaceutical company with a diverse portfolio of over 280 pharmaceutical products, primarily in the United States. The company operates in three segments: Generics, Specialty, and AvKARE. The Generics segment focuses on complex product categories and therapeutic areas, including injectables and biosimilars. The Specialty segment is expanding its portfolio of branded pharmaceuticals aimed at central nervous system and endocrine disorders. The AvKARE segment distributes pharmaceuticals and other products to the U.S. federal government, retail, and institutional markets.

Amneal is committed to making health possible through the development, manufacturing, and distribution of high-quality pharmaceuticals. The company’s efforts to increase the availability of Naloxone HCI Nasal Spray are a significant step in addressing the opioid crisis in the U.S., potentially saving countless lives by providing easy access to this critical rescue medication.