Naltrexone

The risk of relapse after abstinence from opioid dependence is a long-standing clinical challenge in the field of addiction treatment, and the advent of naltrexone provides an important solution to this dilemma. As a pure opioid receptor antagonist, it can competitively block μ-opioid receptors, completely eliminate the euphoria caused by opioids, and does not produce addiction or physical dependence. It is clinically mainly used for maintenance treatment of patients with opioid dependence after detoxification to reduce the risk of relapse. Meanwhile, it is also approved for adjuvant treatment of alcohol dependence, helping patients reduce the urge to drink and lower the recurrence rate. The applicable population covers addiction patients who have completed acute detoxification treatment, and people with alcohol dependence who need adjuvant intervention after clinical evaluation.

The global naltrexone market size maintains a steady growth trend. In 2023, the market size was approximately USD 180 million, with a compound annual growth rate of around 4.7%. From the perspective of competitive landscape, the United States and Europe are the major consumer markets. The original research products still occupy the market share of the mid-to-high end, while generic drugs, relying on their cost advantages, are rapidly penetrating into primary treatment scenarios. China and India are the main suppliers of naltrexone API globally. With the continuous release of global demand for addiction treatment, coupled with the emphasis placed by public health policies of various countries on addiction intervention, the market demand for naltrexone API is expected to maintain a steady rise.

The original research enterprise of naltrexone is DuPont Pharmaceuticals, with the original brand name Revia, and the core compound patent expired in 1996. The main dosage forms approved for the original product include 50mg tablets and long-acting injections. Among them, the 50mg oral tablet has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs* of China. At present, multiple domestic enterprises have obtained CDE registration numbers for naltrexone API with the status of A, which can be marketed and sold in China. Meanwhile, the naltrexone oral preparations of multiple enterprises have been approved for marketing. (Data as of April 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for naltrexone API, and most products are available in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for API R&D, quality research and declaration processes.