丁苯那嗪

Central nervous system movement disorder diseases such as Huntington's disease and tardive dyskinesia have long imposed heavy burdens on patients and caregivers due to the high difficulty of symptom control and limited optional drugs. As a representative drug of vesicular monoamine transporter 2 (VMAT2) inhibitors, tetrabenazine reversibly inhibits the uptake of monoamine neurotransmitters in the central nervous system and reduces the synaptic concentration of neurotransmitters such as dopamine, thereby decreasing the attack frequency and severity of involuntary movements. It is currently the first-line therapeutic drug for Huntington's disease-related chorea symptoms, and can also be used for symptom improvement of adult tardive dyskinesia, covering multiple types of patients with movement disorders in the departments of neurology and psychiatry.

The global market size related to tetrabenazine has maintained steady growth in recent years. In 2023, the overall market size was close to 1.2 billion US dollars, among which the growth rate of the Chinese market was higher than the global average, with a compound annual growth rate of 17%. In terms of competitive landscape, the original research product still occupies the major global market share. At present, a number of domestic enterprises have obtained approval for generic drug preparations. After tetrabenazine tablets were included in the National Medical Insurance Catalogue in 2021, the accessibility of drugs for patients has been greatly improved, which has driven the continuous rise in demand for upstream API, and the layout progress of domestic API enterprises is also gradually accelerating.

The original research enterprise of tetrabenazine is Teva Pharmaceutical Industries from Israel, and the original research brand name is Xenazine. Its core compound patent in the United States expired in 2015, and the relevant preparation patent in China expired in 2022. The main dosage form approved for the original research product is tablet, with specifications including 12.5mg and 25mg. The original research product has been included in the FDA Reference Listed Drug Catalogue, and has also been included in the Chinese Catalogue of Reference Preparations for Chemical Drugs. In terms of domestic API registration, at present, the tetrabenazine APIs of a number of enterprises have obtained CDE registration numbers with the status of A (approved for use in marketed preparations), and multiple generic drug preparation varieties have been approved for marketing in China. (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 tetrabenazine API. The full series of products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most products are available from stock. In-stock orders placed before 16:00 can be shipped on the same day, which can fully meet the reference standard use needs of pharmaceutical enterprises in all links of R&D, quality research and production quality control, and provide stable support for the R&D, declaration and compliant production of relevant products.