Triamterene

As a commonly used potassium-sparing diuretic in clinical practice, the mechanism of action of triamterene is different from that of thiazide and loop diuretics. By directly inhibiting the sodium-potassium exchange process in the renal distal convoluted tubule and collecting duct, it promotes the excretion of sodium and chloride ions while reducing the loss of potassium ions. Its diuretic effect is relatively mild and the risk of hypokalemia is lower. It is mainly used clinically to treat various edematous diseases, including edema caused by heart failure, cirrhotic ascites and nephrotic syndrome. It can also be used in combination with potassium-excreting diuretics to balance serum potassium levels, and the applicable population covers adult edema patients and chronic disease groups requiring collaborative control of fluid retention. Regular monitoring of serum potassium concentration is required for long-term medication.

At present, the domestic triamterene market is mainly supplied by generic drugs, and the overall market size is stable at about 320 million yuan. In recent years, affected by the upgrading of chronic disease management needs and the popularization of diuretic combination regimens, the compound annual growth rate has remained at about 4.1%. In terms of competition pattern, there are about 12 domestic preparation manufacturers, the main suppliers of API are local pharmaceutical enterprises, there is no original research patent restriction, the price system is generally stable under the regulation of essential drug supply guarantee policies, and the demand from primary medical institutions accounts for more than 60%.

The original research enterprise of triamterene is GlaxoSmithKline, with the original trade name Dyrenium, and the core compound patent expired globally in the 1970s. The main dosage form approved for the original research is tablet, with specifications including 50mg and 100mg, and its 50mg tablet has been included in the FDA Reference Listed Drug Catalog. On the domestic side, at present, 11 enterprises have completed the registration of triamterene API in CDE and obtained the A status label. Domestic triamterene tablets and compound triamterene tablets have been approved for marketing for many years, and belong to the varieties in the Class A medical insurance catalog. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for triamterene, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the reference standard requirements for the whole process of API R&D, quality research and registration.