Sufentanil

Perioperative pain management and the treatment of chronic severe pain are core demands in the field of clinical analgesia. Opioid analgesics, with their precise central analgesic effects, remain the first-line choice for moderate to severe pain intervention. As a highly selective μ-opioid receptor agonist of the fentanyl family, sufentanil has an analgesic potency approximately 5 to 10 times that of fentanyl. Meanwhile, it has the clinical advantages of faster onset, longer duration of action, and lower incidence of respiratory depression adverse reactions. At present, it is widely used in general anesthesia induction and maintenance, postoperative intravenous analgesia, labor analgesia, and the treatment of chronic refractory pain such as cancer pain, covering all age groups including adults and children, and is one of the core drugs in clinical analgesia regimens.

The current global sufentanil market size is growing steadily. In 2023, the market size was approximately USD 1.87 billion, with a compound annual growth rate maintained at around 4.2%. Driven by the growth in surgical volume and the increase in the penetration rate of standardized cancer pain treatment in the domestic market, the sales of sufentanil in sample hospitals exceeded RMB 2.2 billion in 2023, accounting for nearly 35% of the opioid analgesic market. In terms of the competitive landscape, the domestic preparation market has long presented a pattern of joint supply by the original research manufacturer and two local generic pharmaceutical enterprises. Affected by the control policies for narcotic drugs, the industry access barrier is relatively high, and the compliance qualification and production stability of the API supply end are the core competitive factors for enterprises.

The original research enterprise of sufentanil is Janssen Pharmaceutica N.V. (Janssen Pharmaceuticals under Johnson & Johnson), with the original brand name Sufenta®. Its core compound patent expired globally in 2008. The main dosage form approved for the original product is injection, with specifications covering 1ml:50μg, 2ml:100μg, and 5ml:250μg. The original injection has been included in the China Listed Drug Catalogue as a reference preparation, and is also included in the FDA Reference Preparation Catalogue. Up to now, more than 10 domestic enterprises have obtained A status for their sufentanil APIs through CDE registration, and all the preparation varieties approved for marketing are injections. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of sufentanil impurity reference standards. The products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most products are in regular stock, and spot orders placed before 16:00 can be shipped on the same day. It can provide stable reference material support for API and preparation enterprises in the links of quality research, stability study, registration declaration, etc.