Pentazocine

The clinical selection of opioid analgesics has long faced the difficulty of balancing analgesic effect and addiction risk. As the first opioid receptor agonist-antagonist applied in clinical practice, pentazocine provides a differentiated solution to this dilemma. It exerts an analgesic effect by agonizing κ receptors and partially antagonizing μ receptors, with an analgesic potency approximately 1/3 that of morphine. Its risks of respiratory depression and addiction are far lower than those of pure opioid receptor agonists. Clinically, it is mainly used to relieve moderate to severe postoperative pain, traumatic pain and cancer pain, especially suitable for patient groups who require repeated analgesia but are worried about opioid dependence. It can also be used as an adjuvant anesthetic for combined anesthesia in surgical procedures.

Currently, the global market size of pentazocine-related preparations is approximately USD 320 million, with a compound annual growth rate of 4.7% in the past three years. The growth momentum mainly comes from the popularization of day surgery and the increase in the penetration rate of standardized cancer pain treatment. The Chinese market is the fastest-growing region, with a compound annual growth rate of 8.2%, and its terminal sales exceeded RMB 600 million in 2023. In terms of the competitive landscape, the domestic preparation market is dominated by generic drugs, with a total of 17 marketing approvals for pentazocine preparations involving 11 manufacturers. Centralized procurement has not yet covered this variety, there is still a certain capacity gap in API supply, and manufacturers with registration qualifications have strong bargaining power.

The original research enterprise of pentazocine is Sterling Winthrop (US), with the original brand name Talwin, and the core compound patent expired worldwide in the 1980s. At present, the mainstream international reference listed drug is the pentazocine hydrochloride injection developed by the original research company, with a specification of 30mg/1mL, which has been included in the FDA Reference Listed Drug Catalog. For the domestic market, as of now, there are 6 pentazocine API registration entries on the CDE API registration platform, 3 of which are in status A and can support associated review. The domestically approved and marketed preparations are mainly pentazocine hydrochloride injection and pentazocine lactate injection, and no imported original research preparation has been approved. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of pentazocine impurity reference standards. Most products are in stock. In-stock products ordered before 16:00 will be shipped on the same day, which can meet the reference standard requirements for the whole process from API R&D to registration declaration. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, helping enterprises efficiently complete quality research and registration declaration.