Valdecoxib

As a specific cyclooxygenase-2 (COX-2) inhibitor belonging to non-steroidal anti-inflammatory drugs, valdecoxib selectively blocks the synthesis of prostaglandins mediated by COX-2, avoiding the risk of gastrointestinal mucosal damage caused by traditional non-steroidal anti-inflammatory drugs, with stronger analgesic and anti-inflammatory effects and better safety. It is mainly used clinically to relieve the symptoms of joint swelling and pain caused by osteoarthritis and rheumatoid arthritis, and can also be used for the short-term treatment of acute postoperative pain in adults, and is suitable for the patient population requiring long-term anti-inflammatory and analgesic treatment and at high risk of gastrointestinal adverse reactions.

The global market size related to valdecoxib was approximately USD 420 million in 2023. Driven by the rising prevalence of osteoarticular diseases in the process of population aging, the compound annual growth rate from 2024 to 2030 is expected to remain at around 3.8%. At present, the market is dominated by the original research products, and generic API from Indian and Chinese enterprises have gradually entered the international market. It has not been included in the centralized procurement catalogue in China yet, and the generic drug substitution space is still in the stage to be released.

The original research enterprise of valdecoxib is Pfizer, and the original research brand name is Bextra. Its compound patent in the United States expired in 2012, and the core patent in the European Union expired in 2013. The main dosage form approved for the original research product is tablet, with specifications including 5mg, 10mg and 20mg, which has been listed in the FDA Reference Listed Drug Catalog. As of October 2024, no valdecoxib preparation has been approved for marketing in China, no valid A status registration number has been found on the CDE API registration platform for the time being, and DMF filing is still in a blank stage. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of valdecoxib impurity reference standards, covering all categories such as synthetic process intermediates and degradation impurities. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day. All products comply with the regulatory requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully support the full-process needs of API R&D, quality research and registration declaration of this variety.