Probenecid

Hyperuricemia and gout, as metabolic chronic diseases, have seen their prevalence rising year by year, and uricosuric drugs are an important branch in clinical uric acid-lowering therapy. Probenecid is a benzoic acid derivative uricosuric drug, whose mechanism of action is to specifically inhibit the reabsorption of urate by the proximal renal tubules, increase the excretion of uric acid and thus reduce the blood uric acid level. It is mainly used clinically for the long-term control of chronic gout and hyperuricemia, and can also be used as an adjuvant drug for antibiotics. By inhibiting the renal tubular excretion of penicillins and cephalosporins, it increases their plasma concentration to prolong the duration of action. The applicable population includes patients with intermittent gout without urinary calculi and infected persons who need to enhance the efficacy of antibiotics.

At present, the global market size of probenecid API is approximately US$120 million, and the compound annual growth rate from 2023 to 2028 is expected to remain at 3.8%. The demand side mainly comes from two scenarios: chronic disease management of gout and antibiotic efficacy enhancement, among which the demand growth rate in emerging markets can reach more than 5% along with the rising prevalence of gout. In terms of competitive landscape, the global production capacity is concentrated in China and India. Chinese enterprises account for about 62% of the global supply by virtue of their cost and compliance advantages; the domestic market has not been included in the national centralized volume procurement at present, and the competition on the preparation side is dominated by generic drugs, with a relatively stable price system.

The original research enterprise of probenecid is Merck & Co., Inc. (MSD) of the United States, and the original research brand name is Benemid®. The core compound patent expired globally in 1982. The main dosage form approved by the original research is tablet with a specification of 500mg, which has been included in the FDA Reference Listed Drug Catalog, and also included in the China Listed Drug Catalog as a reference preparation. At present, 4 enterprises have obtained A-status registration for probenecid API on the API registration platform of China CDE, and multiple domestic enterprises have obtained marketing approval for probenecid oral tablets. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the demand for probenecid quality research and compliance declaration, CATO provides a full set of impurity reference standards for this API, covering all types of process impurities and degradation impurities. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards meet the dual regulatory requirements of the Chinese Pharmacopoeia and FDA, and can directly support the whole process of quality research and registration declaration of APIs and preparations.