Butylphthalide

Acute ischemic stroke is the leading cause of death and disability in adults in China, with a complex pathogenesis, among which cerebral microcirculation disturbance and nerve cell injury are the core links leading to poor prognosis. Butylphthalide is an innovative anti-cerebral ischemia drug independently developed in China. Through the triple mechanisms of reconstructing microcirculation in the ischemic area, protecting mitochondrial function and inhibiting thrombosis, it can effectively improve the blood supply in the cerebral ischemic area and reduce neurological function deficit. It is mainly used for the treatment of mild and moderate acute ischemic stroke, applicable to adult patients within 48 hours of onset, and is one of the core drugs for the treatment of acute stroke in China.

The market size of butylphthalide in China has maintained steady growth for a long time. In 2023, the overall market size has exceeded 8 billion yuan, among which the annual compound growth rate of the API and related preparation market is nearly 5%. The competitive landscape presents an obvious characteristic of being dominated by the exclusive original research drug. With the expiration of core patents, more than 3 domestic enterprises have been approved for generic preparations in recent years. After butylphthalide soft capsules were included in the centralized procurement in 2021, the market penetration rate of generic drugs has gradually increased, and the demand for APIs has been released accordingly. In 2024, the domestic API market gap is about 120 tons.

The original research enterprise of butylphthalide is CSPC NBP Pharmaceutical Co., Ltd., and the original research trade name is "恩必普 (NBP)". The core compound patent expired in 2023. The marketed original dosage forms include butylphthalide soft capsules (specification: 0.1g) and butylphthalide and sodium chloride injection (specification: 100ml: butylphthalide 25mg and sodium chloride 0.9g). Both dosage forms have been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the National Medical Products Administration. Up to now, there are 4 registration entries of butylphthalide APIs including the original research drug on the CDE API registration platform, among which 2 have been approved for use in marketed preparations. In China, 3 generic drugs of butylphthalide soft capsules and 1 generic drug of butylphthalide and sodium chloride injection have been approved for marketing. (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 butylphthalide API, covering the full-process research needs such as synthetic starting materials, intermediates and degradation products. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can be directly used for API quality research, stability study and generic drug consistency evaluation declaration.