Tiapride

Tic disorder is a neurodevelopmental disease with high incidence among children and adolescents, and there has been a long-term lack of treatment options with both safety and tolerability in clinical practice. The emergence of tiapride has filled the medication gap in this细分 field. As a benzamide antipsychotic drug, it exerts the effect of stabilizing nerve excitability by antagonizing central dopamine D2 receptors and inhibiting the excessive activation of the serotonergic system. It is not only a first-line drug for tic disorders in children in clinical practice, but also can be used for symptomatic treatment of senile psychomotor disorders, mental disorders caused by alcoholism, as well as neuralgia symptoms such as intractable headache and painful spasm, with applicable population covering all age groups, and the safety of long-term medication has been verified by a large number of clinical data.

The global market size of tiapride has maintained steady growth all year round. In 2023, the market size was approximately USD 230 million, with China's market share accounting for more than 35%, and the compound annual growth rate maintained at around 5.8%. The domestic market is dominated by generic drug supply. Due to the early launch time of this drug, the overall competitive landscape is relatively fragmented. At present, more than 20 enterprises have been approved to produce tiapride preparations, among which oral dosage forms are the mainstream in the market. In the provincial centralized procurement since 2022, the average bid price of tiapride tablets has decreased by 47%, further promoting the improvement of clinical accessibility at the primary level.

The original research enterprise of tiapride is Sanofi, with the original research trade name "Tiapridal", and its core compound patent expired worldwide in the 1980s. The main dosage forms approved by the original research include 100mg tablets and 50mg/2ml injections. At present, both dosage forms have been included in the FDA Reference Listed Drug Catalog, and the tablets have also been included in the *Catalog of Reference Preparations for Chemical Drugs (9th Batch)* of China. In terms of domestic API registration, 8 enterprises including Jiangsu Nhwa Pharmaceutical and Shandong Xinhua Pharmaceutical have obtained A-status API registration numbers at present, and the domestically approved preparation varieties cover two major dosage forms: tablets and injections. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of tiapride impurity reference standards. All products meet the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA. Most impurities can be supplied from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day, which can fully meet the full-process R&D needs of API enterprises such as quality research and consistency evaluation.