Oxaprozin

Chronic inflammatory diseases such as chronic osteoarthritis and rheumatoid arthritis have long plagued the middle-aged and elderly population, and the core pathological process of these diseases is closely related to the excessive synthesis of prostaglandins mediated by cyclooxygenase (COX). Oxaprozin belongs to propionic acid class non-steroidal anti-inflammatory drugs (NSAIDs). It reduces the production of inflammatory mediators by selectively inhibiting the activity of COX, and has the triple effects of anti-inflammation, analgesia and antipyresis. With a long half-life of 50-60 hours, it only needs to be taken once a day, and its patient compliance is significantly better than that of traditional short-acting NSAIDs. It is clinically mainly used for symptomatic treatment of various types of arthritis, ankylosing spondylitis, postoperative and traumatic pain, and its applicable population covers adult patients with chronic pain and inflammatory diseases. The incidence of adverse gastrointestinal reactions is lower than that of similar non-selective NSAIDs.

The prevalence rate of osteoarthritis among people over 60 years old in China exceeds 50%, and the corresponding market demand for analgesic and anti-inflammatory drugs continues to rise. In 2023, the domestic market size of oxaprozin preparations was approximately 320 million yuan, with a compound annual growth rate of 6.8% in the recent three years. The growth momentum mainly comes from the increased penetration rate of chronic pain management in primary medical institutions. The current competitive landscape is dominated by generic drugs. More than 10 domestic enterprises have obtained approval for oxaprozin preparation licenses, and the localization rate of API exceeds 90%. In the 2022 provincial centralized drug procurement, the average bid price of oxaprozin enteric-coated tablets decreased by 47%, further promoting the improvement of clinical accessibility.

The original developer of oxaprozin is Wyeth-Ayerst Laboratories (Wyeth) in the United States, and the original brand name is Daypro. The US compound patent expired in 2003. The main dosage form approved for the original drug is tablet, with a specification of 600mg, which has been included in the FDA Orange Book Reference Listed Drug Catalog, and the original reference listed drug has not been introduced in China yet. In terms of domestic API registration, as of now, there are 8 oxaprozin registration numbers on the CDE API registration platform, among which 6 have been converted to A status and can be used for associated domestic preparation declaration. The domestically approved marketed preparation dosage forms include enteric-coated tablets, enteric-coated capsules and common tablets. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of oxaprozin impurity reference standards, covering the full spectrum of process impurities and degradation impurities. Most products have sufficient stock. Spot orders placed before 16:00 can be shipped on the same day. All products comply with the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA, and can fully meet the full-process R&D needs of API enterprises and preparation manufacturers, such as quality research, stability study, registration declaration, etc.