Prilocaine

As a commonly used amide local anesthetic in clinical practice, prilocaine reversibly blocks the sodium ion channels on the nerve cell membrane to inhibit the generation and conduction of nerve impulses, with mild analgesic effect and moderate duration. Compared with similar drugs, it has a lower incidence of cardiovascular and nervous system adverse reactions. It is clinically mainly used for local infiltration anesthesia in surgical operations, peripheral nerve block, and anesthesia for dental procedures. It can also be combined with lidocaine to form a compound preparation for epidermal anesthesia, which is suitable for most adult patients requiring local anesthesia, and also has definite application value in anesthesia for minor surgery in children.

At present, the global local anesthetic market size has exceeded 3 billion US dollars, among which amide anesthetics account for more than 65%, and the compound annual growth rate is maintained at around 4.2%. As a basic local anesthetic variety, prilocaine has stable clinical demand, and its domestic market size is about 230 million yuan, with generic drugs occupying a dominant position. More than 10 enterprises have obtained preparation approvals, and the supply of active pharmaceutical ingredients (APIs) is mainly from local enterprises. After the implementation of centralized procurement, the terminal price has dropped significantly, further driving the increase in the usage volume of primary medical institutions.

The original developer of prilocaine is AstraZeneca, with the original brand name Citanest. The core compound patent expired globally in 1986. At present, the mainstream dosage form on the market is injection, with specifications including 10ml:200mg and 20ml:400mg. The original preparation has been included in the FDA Reference Listed Drug Catalog, and the original product has not been imported into China. According to the domestic API registration platform, at present, 6 enterprises have obtained A status for their prilocaine APIs through CDE registration, which can be used for associated review. A number of preparation varieties such as prilocaine hydrochloride injection and prilocaine and lidocaine cream have been approved for marketing in China. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of prilocaine impurity reference standards, covering the full research path requirements including synthesis process impurities and degradation impurities. 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 regulatory systems such as the Chinese Pharmacopoeia and FDA, and can be directly used for API quality research, qualitative and quantitative analysis of impurities, and work related to registration and declaration.