Desmopressin

Central diabetes insipidus is an endocrine disease with polyuria and polydipsia as the core manifestations. For a long time, there has been an urgent clinical demand for precise antidiuretic treatment, and desmopressin is a polypeptide drug developed exactly for this demand. It selectively agonizes the V2 receptors in the renal collecting ducts to improve the reabsorption capacity of renal tubules for water. While reducing urine volume, it has extremely weak effect on V1 receptors, thus avoiding adverse reactions such as升压. At present, its indications cover central diabetes insipidus, nocturnal enuresis, hemophilia A, von Willebrand disease, as well as the prevention and treatment of surgical bleeding. Its applicable population covers patients of all age groups from children to the elderly, and it is a first-line drug in the relevant disease fields.

The global desmopressin market size has exceeded 700 million US dollars, with an annual compound growth rate maintained at around 4.8%. The growth drivers mainly come from the improvement of the diagnosis rate of rare diseases, the increase of urological surgery volume and the release of drug demand for senile nocturnal enuresis. In the domestic market, the annual sales volume in sample hospitals has exceeded 300 million yuan. At the current stage, the competition pattern is dominated by original research products, and the number of domestic generic preparations is small. With the advancement of consistency evaluation and the coverage of centralized procurement policies, the penetration rate of generic drugs is gradually increasing, and the demand for domestic substitution of upstream API is also growing accordingly.

The original research enterprise of desmopressin is Ferring Pharmaceuticals, with the trade name Minirin. The core compound patent of desmopressin expired in 2005 in the United States and Europe, and the relevant core patents in China also expired around 2006. At present, the main dosage forms of the original research product approved globally include tablets, injections and nasal sprays. The common specifications of tablets are 0.1mg and 0.2mg, and the injection is 4μg/1ml. Relevant dosage forms have been included in the FDA Reference Listed Drug Catalog and the Chinese *Catalog of Reference Preparations for Chemical Drugs*. In terms of domestic API registration, a number of enterprises including Ferring have obtained API registration numbers with A status, and multiple varieties of domestic generic preparations have also been approved for marketing. (Data as of July 2025, please refer to the official website of CDE for the latest information)

In response to the R&D and production quality control requirements of desmopressin, CATO can provide a full set of impurity reference standards for this API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All products comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can directly support the whole process work such as API registration and declaration, impurity research and daily quality testing.

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