Methadone

Opioid addiction is a severe challenge in the global public health sector. As an opioid receptor agonist, methadone is currently the core medication for maintenance treatment of opioid dependence. Its mechanism of action is to bind to μ-opioid receptors and competitively block the interaction between exogenous opioids and receptors, which can effectively control withdrawal symptoms and reduce addicts' craving for illegal opioids such as heroin. In addition to being used clinically for analgesia of moderate to severe chronic pain, it is more widely used in opioid addiction substitution maintenance therapy, and is an important clinical measure to reduce drug-related harms and lower the infection risk of blood-borne diseases such as AIDS. The applicable population includes patients with opioid dependence and some patients with refractory pain.

The global methadone market size has maintained steady growth in recent years. In 2023, the market size was approximately USD 870 million, with a compound annual growth rate of around 3.2%. Driven by national drug prevention and control policies, the coverage rate of methadone maintenance treatment programs in low- and middle-income countries continues to increase, which has become the core driving force for market growth. In terms of the competitive landscape, the United States and Europe are the major consumer markets, where generic drugs account for more than 90% of the market share. In the domestic market, supplies come from several compliant pharmaceutical enterprises. All products are included in the medical insurance catalog, and production and distribution are strictly carried out in accordance with the control requirements for narcotic drugs, ensuring stable market supply.

The original developer of methadone is Eli Lilly and Company, with the original brand name Dolophine. Its core compound patent expired in the 1970s. At present, the mainstream dosage forms include oral solution, tablets and injections. Common specifications are 1mg/ml for oral solution and 5mg/10mg for tablets. The original product has been included in the FDA Reference Listed Drug Catalog. The methadone preparations approved for marketing in China include oral solution and tablets. The API registration platform shows that methadone APIs from 3 domestic enterprises have been registered with status A and can be legally supplied for preparation production. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for methadone API. Most products are 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 the Chinese Pharmacopoeia and FDA, and can fully support the impurity testing needs of API R&D, quality research and routine production.