Edoxaban

Thromboembolic diseases such as atrial fibrillation and deep vein thrombosis have long ranked among the leading fatal diseases worldwide. The core requirement of clinical anticoagulant therapy is to reduce the risk of thrombosis while minimizing bleeding adverse reactions. Edoxaban is a new type of oral factor Xa inhibitor. By selectively blocking the activity of coagulation factor Xa, it interrupts the core step of the coagulation cascade. While ensuring the anticoagulant effect, it greatly reduces the disadvantages of traditional warfarin, such as the need for frequent monitoring of coagulation function and numerous drug interactions. Currently, it is approved for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as the treatment and recurrence prevention of deep vein thrombosis and pulmonary embolism in adults, and is particularly suitable for middle-aged and elderly patients who require long-term anticoagulation and have poor medication compliance.

The global market size of antithrombotic drugs has exceeded 24 billion US dollars, among which new oral anticoagulants account for more than 60%, with a compound annual growth rate of over 8%. As a fourth-generation factor Xa inhibitor, edoxaban has a continuously increasing penetration rate among the elderly patient group due to its lower risk of intracranial hemorrhage. At present, the domestic market has entered a rapid volume expansion stage, and the sales volume in domestic sample hospitals in 2023 increased by more than 120% year-on-year. In terms of the competitive landscape, the original research product still accounts for more than 70% of the market share. Three domestic enterprises have obtained approval documents for generic drug preparations. With more generic drugs entering the centralized procurement sequence in the future, the market demand is expected to be further released.

The original research enterprise of edoxaban is Daiichi Sankyo Co., Ltd., with the trade name Lixiana®. The expiration date of its Chinese compound patent is 2027. The dosage form approved by the original research is tablet, with three specifications of 15mg, 30mg and 60mg. It has been included in the China Listed Drug Catalogue as a reference preparation, and is also included in the FDA Reference Preparation Catalogue. In terms of API registration, the CDE platform currently includes 12 edoxaban API registration numbers, 9 of which are in status A (approved for use in marketed preparations). 6 generic edoxaban tablet varieties have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for edoxaban API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products comply with the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use needs of API enterprises in the whole process of R&D, declaration and quality control.