Buspirone

Anxiety disorder is one of the mental disorders with the highest prevalence in the world. Most traditional anti-anxiety drugs have adverse reactions such as addiction and excessive sedation, which limit their long-term clinical application. The advent of buspirone provides a safer option for the treatment of such diseases. As a non-benzodiazepine anti-anxiety drug, it regulates the neurotransmission related to anxiety by selectively agonizing 5-HT1A receptors, has no obvious sedative and muscle relaxant effects, and does not cause drug dependence. It is suitable for patients of all ages with generalized anxiety disorder, and can also be used as an adjuvant medication for depression, especially for people who need long-term medication or are intolerant to benzodiazepines.

The global buspirone market size has maintained steady growth in recent years. In 2023, the overall market size was approximately USD 180 million, with the Chinese market accounting for about 22%, and the compound annual growth rate maintained at around 5%. As the core patents have long expired, the global market is dominated by generic drug supply. There are more than 15 domestic preparation manufacturers. After the implementation of centralized procurement, the price of preparations has dropped by more than 70%, driving the continuous rise in demand for upstream APIs. At present, the annual domestic demand for APIs is about 120 tons, and the supply side is dominated by local pharmaceutical companies, with a relatively scattered competitive landscape.

The original research enterprise of buspirone is Bristol-Myers Squibb, and the original research trade name is Buspar. The core compound patent expired globally in 2001. The main dosage forms approved by the original research are oral tablets, with three specifications including 5mg, 10mg and 15mg. The original research tablets have been included in the FDA Reference Listed Drug Catalog, and also included in the *Catalog of Reference Preparations for Chemical Drugs* of China. In terms of domestic API registration, at present, 7 enterprises have obtained A status for their buspirone APIs through CDE registration, and more than 20 domestic enterprises have been approved to produce generic buspirone tablets, realizing the replacement of the original research drug. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of buspirone impurity reference standards, most of which 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 Chinese Pharmacopoeia and FDA, and can fully support the reference substance requirements in the whole process of API R&D, quality research and declaration.