Benzbromarone

In the management of the chronic course of hyperuricemia and gout, uricosuric drugs are one of the first-line treatment options, and benzbromarone is a representative variety of this class of drugs. Its mechanism of action is to selectively inhibit the activities of renal tubular urate transporter 1 (URAT1) and glucose transporter 9 (GLUT9), reduce the reabsorption of uric acid by renal tubules, thereby increasing uric acid excretion and lowering serum uric acid levels. It is clinically mainly used for the treatment of primary hyperuricemia, intermittent gouty arthritis and gouty nodules. The applicable population covers adult patients with hyperuricemia and gout without severe renal insufficiency, and it can be used as an alternative option for patients who are intolerant to allopurinol or have poor therapeutic efficacy.

The domestic anti-gout drug market has maintained a stable growth trend in recent years. In 2023, the overall market size was close to 4 billion yuan, among which benzbromarone accounted for more than 65% of the market share of uricosuric drugs. At present, generic drugs dominate the domestic market pattern. There are more than 10 manufacturers of benzbromarone preparations that have passed the consistency evaluation. In multiple batches of provincial centralized drug procurement, the average bid price of benzbromarone tablets has dropped by more than 50% compared with the maximum procurement limit price, and its clinical accessibility has been significantly improved. At the API level, the number of domestic manufacturers is small, the supply and demand relationship has remained relatively stable for a long time, and there is no publicly verifiable accurate market growth rate data.

The original research enterprise of benzbromarone is Menarini von Heyden GmbH in Germany, and the original research trade name is "Narcaricin®/痛风利仙". Its core compound patent has expired globally before 2001, and there is no core patent restriction at present. The original reference listed drug is 50mg tablet, which has been included in the China Listed Drug Catalog and is also listed as an FDA reference listed drug. In terms of domestic API registration, nearly 10 enterprises have obtained CDE registration numbers for benzbromarone APIs, most of which are in status A (approved for use in marketed preparations); in terms of preparations, multiple dosage forms such as tablets and capsules have been approved for marketing, among which 50mg tablet is the mainstream clinical specification. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of benzbromarone impurity reference standards, covering the full research chain requirements such as process impurities and degradation impurities. Most products support spot supply. Spot orders paid before 16:00 can be shipped on the same day. The products simultaneously meet the requirements of multiple national drug regulatory regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of API enterprises and preparation R&D institutions in quality research and consistency evaluation related work.