Etodolac

In the long-term management of chronic pain diseases such as chronic osteoarthritis and rheumatoid arthritis, non-steroidal anti-inflammatory drugs are first-line clinical medications. However, the problem that traditional NSAIDs are prone to cause gastrointestinal adverse reactions has long restricted medication compliance. Etodolac is a non-steroidal anti-inflammatory drug belonging to the class of selective cyclooxygenase-2 inhibitors. By preferentially inhibiting the synthesis of prostaglandins mediated by COX-2, it exerts anti-inflammatory, analgesic and antipyretic effects while reducing the impacts on gastrointestinal mucosa and platelet function. It is clinically mainly used to relieve the symptoms and signs of osteoarthritis and rheumatoid arthritis, as well as for the symptomatic treatment of acute pain such as postoperative pain and toothache, and is particularly suitable for middle-aged and elderly patients who require long-term medication and have poor gastrointestinal tolerance.

At present, the global market size of etodolac preparations is stably around US$1.2 billion, with a compound annual growth rate of 3.2%. The growth momentum mainly comes from the rising prevalence of chronic osteoarticular diseases and the expansion of analgesic demand among the elderly population. In terms of the domestic market, the sales of etodolac at the terminals of public medical institutions have maintained an annual growth rate of about 8% in recent years. The competitive landscape is dominated by generic drugs, with the market share of original research products less than 15%. More than 20 domestic enterprises have obtained approval for the production of etodolac preparations. Volume-based procurement has driven down the prices of preparations, and at the same time, it has also driven the continuous increase in demand for upstream API. The current annual domestic demand for etodolac API exceeds 150 tons.

The original research enterprise of etodolac is Wyeth Ayerst, with the original brand name "Lodine". The core compound patent expired in the United States in 2004, and the compound patent in China has also expired. The main dosage forms approved for the original research include tablets, sustained-release tablets and capsules, with specifications covering 200mg, 300mg, 400mg, 500mg, etc. The original sustained-release tablets have been included in the Reference Preparations Catalogue of Chemical Drugs issued by the NMPA, and are also included in the FDA Reference Preparations Catalogue. Up to now, there are 12 etodolac API registration numbers on the API Registration Platform of China CDE, of which 7 are in A status. More than 15 etodolac preparation varieties have been approved for marketing in China, including three dosage forms: tablets, sustained-release tablets and capsules. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of etodolac impurity reference standards. Most products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the compliance needs of various stages such as API R&D, quality research and impurity release.