Nabumetone

For long-term analgesic and anti-inflammatory treatment of chronic inflammatory diseases, there has always been a clinical pain point of gastrointestinal adverse reactions. The advent of non-acidic non-steroidal anti-inflammatory drugs provides a safer option for such patients. Nabumetone is a prodrug-type non-steroidal anti-inflammatory drug. After entering the human body, it is metabolized by the liver into the active metabolite 6-methoxy-2-naphthylacetic acid, which exerts anti-inflammatory, analgesic and antipyretic effects by inhibiting cyclooxygenase and reducing the synthesis of prostaglandins. Its structural feature of no acidic group greatly reduces the risk of gastrointestinal mucosal injury. It is mainly used for long-term symptom control of rheumatoid arthritis and osteoarthritis, and can also be used for the relief of acute pain such as soft tissue injury and postoperative pain, especially suitable for elderly patients and people with a history of gastrointestinal diseases who need long-term anti-inflammatory treatment.

The global market size of nabumetone is approximately USD 320 million, with a compound annual growth rate maintained at around 2.1%. The growth momentum mainly comes from the expansion of the osteoarthritis patient group brought about by the intensification of population aging. The domestic market size is approximately RMB 470 million. As the core patents have long expired, the current market is dominated by generic drugs, and local enterprises account for more than 85% of the market share. After the implementation of volume-based procurement, the price of nabumetone preparations has dropped by more than 60%, and the clinical utilization rate has increased significantly. At the same time, it has also driven the continuous rise of upstream demand for active pharmaceutical ingredients. In 2023, the domestic consumption of nabumetone API increased by 18% year-on-year.

The original research enterprise of nabumetone is AstraZeneca, with the original brand name Relifex, and the core compound patent expired globally in 1999. The main dosage forms approved for the original drug are tablets, with specifications including 500mg and 750mg. Its 500mg tablet has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation listed by the FDA. At present, 8 enterprises have obtained A-status registration numbers for nabumetone APIs on the domestic CDE API registration platform, and another 3 enterprises are in the registration publicity stage. The domestically approved nabumetone preparations include three dosage forms: tablets, capsules and dry suspensions, involving more than 20 manufacturers. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of nabumetone impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of pharmaceutical enterprises in various R&D and production scenarios such as impurity research, quality control, and generic drug consistency evaluation.