Robenacoxib

Osteoarthritis is a chronic degenerative joint disease with a high incidence globally. Patients often suffer from persistent pain and limited joint function, and non-steroidal anti-inflammatory drugs (NSAIDs) are the core medications for symptom relief in clinical treatment. Robenacoxib is a second-generation highly selective cyclooxygenase-2 (COX-2) inhibitor. By precisely blocking the synthesis of prostaglandins mediated by COX-2, it exerts a potent anti-inflammatory and analgesic effect while greatly reducing the risk of gastrointestinal adverse reactions caused by traditional NSAIDs. It is mainly used for symptom treatment of osteoarthritis in both acute and chronic stages, and can also relieve acute pain and primary dysmenorrhea. It is suitable for patient groups who require long-term anti-inflammatory and analgesic treatment and have poor gastrointestinal tolerance.

The global market size of robenacoxib has shown a steady growth trend in recent years. In 2023, the market size was approximately USD 420 million, with a compound annual growth rate maintained at around 3.7%. Its growth drivers mainly come from the year-on-year increase in the prevalence of osteoarthritis and the rising demand for high-safety analgesic drugs among patients. In terms of the competitive landscape, the original research product still dominates the global high-end market, while generic drug enterprises in India and China are gradually deploying the R&D of API and preparations. China is currently in the early stage of generic drug application, and no product has yet been included in the national centralized procurement catalogue.

The original research enterprise of robenacoxib is Merck Sharp & Dohme (MSD), with the original brand name Arcoxia. The core compound patent of this drug expires in China in 2024. The main dosage forms approved for the original product include tablets, with specifications covering 30mg, 60mg, 90mg and 120mg, which have been included in the FDA Reference Listed Drug Catalog and the *Catalogue of Reference Preparations for Chemical Drugs* of China. In terms of domestic API registration, there is currently no domestic robenacoxib API that has obtained an A-status registration number, while multiple imported and domestic preparations have been approved for marketing by the National Medical Products Administration (NMPA) of China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for robenacoxib API, covering all categories such as process impurities and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the impurity research needs of pharmaceutical enterprises at all stages from R&D to mass production.