Lornoxicam

As a representative variety of thiazine derivatives among non-steroidal anti-inflammatory drugs (NSAIDs), lornoxicam blocks prostaglandin synthesis by potently inhibiting the activity of cyclooxygenase (COX), and at the same time activates the endogenous opioid peptide system to exert central analgesic effects. Its dual mechanism of action gives it an analgesic effect 10 to 20 times that of ordinary NSAIDs, with a lower incidence of gastrointestinal adverse reactions. It is mainly used clinically for anti-inflammatory and analgesic treatment of diseases such as acute moderate to severe postoperative pain, osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The applicable population covers surgical patients requiring short-term analgesia and patients with chronic osteoarthropathy requiring long-term control of inflammation progression, and it is especially suitable for pain populations intolerant to adverse reactions of opioid drugs.

The global lornoxicam market size was approximately USD 1.28 billion in 2023, and the compound annual growth rate from 2024 to 2030 is expected to be 4.2%. The core growth drivers are the rising prevalence of chronic osteoarthropathy and the increasing demand for non-opioid analgesics under the concept of enhanced recovery after surgery (ERAS). In terms of the domestic market, the sales of lornoxicam in sample hospitals in 2023 were approximately RMB 370 million, of which injections accounted for more than 85%. At present, there are 32 approved preparation approval numbers in China, with generic preparations accounting for more than 90% of the market share, and the original research product accounting for only about 8%. After the implementation of the centralized procurement policy, the terminal price has dropped by more than 60%, and the penetration rate in the primary market continues to increase.

The original research enterprise of lornoxicam is H. Lundbeck A/S (Lundbeck) in Denmark, with the original trade name "Xefo®/可塞风®". The core compound patent expired globally in 2010. Currently, the original research dosage forms approved in China include lornoxicam for injection (8mg) and lornoxicam tablets (4mg, 8mg). Both dosage forms have been included in the China Listed Drug Catalogue and listed as reference preparations. In terms of API registration, as of now, the CDE API registration platform has included 19 lornoxicam registration numbers, of which 11 have been activated in A status, and 6 are in DMF status declared by overseas manufacturers. All domestically approved preparation varieties have realized domestic supporting supply of APIs. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of lornoxicam impurity reference standards, covering a total of 17 kinds of synthesis process impurities, degradation impurities and isomer impurities. Most of the products are in stock. In-stock products ordered before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can directly support the work related to API impurity research, stability investigation and consistency evaluation.