Conivaptan

Hyponatremia is a clinically common electrolyte disorder disease. Among them, euvolemic or hypervolemic hyponatremia caused by syndrome of inappropriate antidiuretic hormone secretion has long lacked a treatment regimen with both safety and targeting properties. Conivaptan is a dual inhibitor of arginine vasopressin V1a/V2 receptors, which can simultaneously block the V2 receptor-mediated water reabsorption process and the V1a receptor-mediated vasoconstriction effect, increasing free water excretion while avoiding excessive vasodilation. It is mainly used clinically to treat euvolemic/hypervolemic hyponatremia with a serum sodium level <125 mEq/L or with symptoms, especially suitable for adult patients related to heart failure, liver cirrhosis and syndrome of inappropriate antidiuretic hormone secretion.

The global conivaptan market size was approximately USD 210 million in 2023, with a compound annual growth rate of 6.2% from 2019 to 2023. The core growth driver comes from the increasing clinical demand for precise treatment regimens for hyponatremia. In terms of competitive landscape, the original research product still occupies more than 70% of the global market share at present, while the domestic market is still in the early stage of generic drug layout. Only a small number of enterprises have submitted registration applications for active pharmaceutical ingredients (APIs) and preparations, and no generic drug has passed the consistency evaluation yet, leaving a considerable market replacement space.

The original research enterprise of conivaptan is Astellas Pharma, and the original brand name is Vaprisol. Its core compound patent in the United States expired in 2009, and the crystal form patent expired in 2019; the compound patent in China expired in 2008, and the preparation patent expired in 2021. The originally marketed dosage form is injection, with specifications of 100ml:20mg and 5ml:10mg, which has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in China's *Catalog of Reference Preparations for Chemical Drugs*. As of the retrieval time, there is no conivaptan API registration number that has been publicized in Status A in China. Only the API registration application submitted by 1 enterprise is under review, and there is no conivaptan preparation product approved for marketing in China. (Data as of September 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of conivaptan impurity reference standards, most of which are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the reference substance needs of the whole process of API R&D, quality research and registration declaration.