Naloxone

Opioid overdose has become one of the prominent challenges to global public health. As a specific opioid receptor antagonist, naloxone can competitively block the binding of opioid receptors such as μ and κ, and rapidly reverse toxic reactions caused by opioids, including respiratory depression, sedation and hypotension. In clinical practice, in addition to the emergency treatment of acute opioid overdose, it can also be used for the diagnosis of opioid dependence, postoperative anesthesia awakening, and adjuvant treatment of acute alcohol poisoning. It covers multiple usage scenarios such as emergency centers, community medical care, anti-drug agencies, and high-risk groups at home, and is a globally recognized core first-aid drug for opioid poisoning with the highest accessibility.

The global naloxone market size was approximately USD 480 million in 2023, and the compound annual growth rate is expected to reach 7.2% by 2028. The increment mainly comes from the public reserve demand under the opioid overdose crisis in North America and the improvement of the first-aid system in emerging markets. Driven by the centralized procurement policy, the annual growth rate of terminal consumption of naloxone preparations in the domestic market has remained above 15% since 2022. Currently, generic drug companies account for more than 90% of the domestic preparation market share, the supply of API is dominated by local enterprises, and the top 3 enterprises account for about 70% of the production capacity.

The original developer of naloxone is DuPont Pharmaceuticals, with the original brand name Narcan. The core compound patent expired globally in 1985. The core dosage forms of the original product include 0.4mg/1ml injection and 4mg nasal spray. Both the injection and the nasal spray have been included in the FDA Reference Listed Drug Catalog, and the domestic Reference Listed Drug catalog includes the original injection and the imported generic nasal spray. According to the domestic API registration platform, up to now, the naloxone APIs of 12 enterprises have passed the CDE registration with the status of A, which can be used for associated review. A variety of dosage forms such as naloxone hydrochloride injection, naloxone hydrochloride for injection, and naloxone hydrochloride nasal spray have been approved for marketing in China. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for naloxone API, covering the full spectrum including process impurities, degradation impurities and enantiomers. The products meet the requirements of the Chinese Pharmacopoeia, FDA and ICH relevant guidelines. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day, which can meet the needs of various stages such as API R&D, registration and declaration, and routine quality control.