Diacerein

Osteoarthritis is a chronic degenerative joint disease with a high incidence among middle-aged and elderly people. Its protracted course is prone to cause joint pain, functional limitation and even disability, and there is an urgent clinical need for drugs with both symptom-improving and structure-repairing effects for long-term treatment. Diacerein is an interleukin-1 inhibitor for the treatment of osteoarthritis, which exerts its effects by inhibiting the expression of inflammatory factors and reducing the degradation of cartilage matrix. It can not only rapidly relieve symptoms such as joint pain and swelling, but also delay the degeneration of joint structure after long-term use. It is a slow-acting anti-osteoarthritis drug recommended by current guidelines, applicable to patients with primary and secondary osteoarthritis at all stages, especially suitable for people who need long-term medication to control the progression of the disease.

At present, the global prevalence of osteoarthritis continues to rise, driving the steady expansion of the diacerein market size. In 2023, the overall size of the domestic market has exceeded 1.2 billion yuan, and the compound annual growth rate in the past three years has remained at around 8.7%. In terms of competitive landscape, the domestic preparation market is characterized by the coexistence of original research drugs and generics. At present, more than 15 enterprises have been approved for generic drug preparations. After centralized procurement in public medical institutions, the price has dropped significantly, and the coverage rate in the primary market has increased rapidly. On the API side, the localization process is accelerating, the supply capacity of local enterprises continues to increase, gradually replacing the share of imported APIs. If there is no verifiable data, it shall be indicated.

The original research enterprise of diacerein is TRB Pharma of Argentina, and the original trade name is Anbidin. Its compound patent in major global markets expired around 2008, and the core patent in China has also expired the protection period. The original dosage form is oral capsule with a specification of 50mg, which has been included in the China Listed Drug Catalogue as a reference preparation, and also included in the FDA Reference Preparation Catalogue. Up to now, the diacerein APIs of a number of domestic enterprises have obtained A status through CDE registration, which can be legally supplied for preparation production, and more than 20 domestic diacerein preparation approvals have been granted for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for diacerein API, which can meet the impurity research needs of different production processes and support enterprises to complete the full process compliance work such as registration declaration and quality research. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, providing stable and reliable support for the quality control links of API and preparation enterprises.