Dabigatran

As a classic novel oral anticoagulant in the clinical anticoagulation field, dabigatran is a direct thrombin inhibitor. It specifically and reversibly blocks the activity of free and bound thrombin, effectively inhibiting fibrin generation and thrombus progression. Compared with traditional warfarin, it does not require routine coagulation function monitoring and has fewer drug interactions. It is mainly used for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, as well as the treatment and recurrence prevention of deep vein thrombosis and pulmonary embolism, providing a safer and more convenient option for patients requiring long-term anticoagulation.

According to public data, the global market size of dabigatran was approximately USD 1.82 billion in 2023. With the rising prevalence of atrial fibrillation and the increasing penetration of primary-level anticoagulation therapy, it is expected to expand steadily at a compound annual growth rate of 2.1% from 2024 to 2029. For the domestic market, the sales volume in sample hospitals reached RMB 1.27 billion in 2023. At present, more than 20 enterprises have obtained approval for generic drug preparations, and multiple products have been included in the national centralized drug procurement. The winning bid prices have dropped by more than 80% compared with the original research drug, which has greatly promoted clinical accessibility and driven the continuous release of upstream API demand.

The original research enterprise of dabigatran is Boehringer Ingelheim, with the original brand name "Pradaxa". Its core compound patent expired in Europe and the United States in 2021, and the Chinese compound patent also officially expired in 2022. The main dosage form approved for the original research drug is capsule, with three specifications of 75mg, 110mg and 150mg, which have been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and the FDA Reference Preparation Catalogue. According to domestic API registration data, more than 30 enterprises have had their dabigatran APIs passed the evaluation and registration of CDE (status A) so far, and multiple domestic enterprises have obtained marketing approval for dabigatran etexilate capsules. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of dabigatran impurity reference standards, covering the demand of the whole research chain including synthesis process and degradation impurities. Most products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. Meanwhile, all products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for the quality research and consistency evaluation work of API and preparation enterprises.