Chlorthalidone

As a commonly used thiazide-like diuretic in clinical practice, chlorthalidone exerts effects of sodium excretion and diuresis, and reduces peripheral vascular resistance by inhibiting the sodium-chloride cotransporter in the anterior segment of the distal convoluted tubule, thereby reducing the reabsorption of sodium ions and water. It has a long-lasting and stable antihypertensive effect, and is an important component of first-line treatment regimens for hypertension. It can also be used for symptomatic treatment of edematous diseases (such as heart failure, cirrhotic ascites), and is especially suitable for middle-aged and elderly patients who require long-term blood pressure control and high-risk groups with combined cardiac insufficiency. Compared with common thiazide diuretics, chlorthalidone has a longer half-life, and its antihypertensive effect can last for more than 24 hours, which can effectively reduce the risk of morning peak hypertension and decrease the incidence of cardiovascular events.

The global chlorthalidone market size has maintained steady growth in recent years, with the overall market size reaching approximately USD 120 million in 2023, and the annual compound growth rate of the sales scale at the terminal of Chinese public medical institutions remains at around 7%. In terms of competitive landscape, the original research product accounts for about 35% of the high-end market. At present, more than 5 domestic generic pharmaceutical enterprises have obtained preparation approvals. With the coverage and promotion of national centralized procurement for antihypertensive drug varieties, the clinical utilization rate of chlorthalidone continues to rise, and the penetration rate in the primary market has increased by more than 40% compared with that in 2020. There is no publicly verifiable segmented market growth forecast data available at present.

The original research enterprise of chlorthalidone is Pfizer, and the original brand name is Hygroton. Its US compound patent expired in 1989, and all core patents in China have passed the protection period. The main dosage form of the original research product is tablet, with common specifications including 25mg, 50mg and 100mg. The original research tablet has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the China Listed Drug Catalog. In terms of domestic API registration, 3 valid A-status API registration numbers have been published on the CDE platform, and another 2 registration information are under review. 7 oral preparation varieties of chlorthalidone have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of chlorthalidone impurity reference standards. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They comply with multiple regulations such as Chinese Pharmacopoeia and FDA, which can fully meet the reference standard requirements in each stage of API R&D, quality research and registration declaration, and provide reliable material basis support for the project advancement of relevant enterprises.

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