Fondaparinux sodium

Venous thromboembolism is a highly prevalent complication among patients undergoing surgery and with orthopedic trauma. Traditional heparin-based anticoagulants have clinical limitations such as thrombocytopenia and high bleeding risk, while the advent of fondaparinux sodium provides a better anticoagulation option for such patients. As a synthetic selective factor Xa inhibitor, fondaparinux sodium binds to antithrombin III with high affinity, selectively inhibits the activity of coagulation factor Xa, and blocks the key step of the coagulation cascade from the source without affecting platelet function. Clinically, it is mainly used for the prevention of deep vein thrombosis in patients undergoing major lower extremity orthopedic surgery, the treatment of acute deep vein thrombosis and pulmonary embolism, and can also be used for the anticoagulation management of patients with non-ST-segment elevation acute coronary syndrome, with a significantly lower bleeding risk than traditional low-molecular-weight heparin.

The global market size of fondaparinux sodium was approximately USD 970 million in 2023, and it is expected to grow steadily at a compound annual growth rate of 4.2% from 2024 to 2030. For the domestic market, with the continuous increase in the volume of orthopedic surgeries and the popularization of standardized anticoagulation therapy, the domestic market size of fondaparinux sodium preparations exceeded RMB 1.8 billion in 2023. The current competitive landscape is dominated by generic drugs, with more than 20 enterprises having obtained preparation approvals. After centralized procurement, the price has dropped significantly, and the clinical utilization rate has continued to rise, driving the demand for APIs to increase year by year.

The original developer of fondaparinux sodium is GlaxoSmithKline, with the original brand name Arixtra. Its core compound patent expired in 2017 in major European and American markets, and the Chinese compound patent also expired in 2017. The main dosage form of the original product is injection, with four specifications: 0.5ml:2.5mg, 0.5ml:5mg, 0.5ml:7.5mg, and 0.5ml:10mg. The original product has been included in the China Listed Drug Catalog as a reference preparation, and is also included in the FDA Reference Preparation Catalog. As of now, there are more than 30 domestic API registration numbers for fondaparinux sodium, most of which are in A status and can be used in association with domestically approved preparation products. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for fondaparinux sodium, most of which are in stock. In-stock orders placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the use requirements in different stages such as API R&D, quality research, and consistency evaluation.