Apixaban

The fatality rate of venous thromboembolic diseases has long ranked among the highest of cardiovascular diseases. Traditional anticoagulants have clinical pain points of high bleeding risk and the need for frequent coagulation function monitoring. As a new oral factor Xa inhibitor, apixaban can bind to both free and bound factor Xa with high selectivity, block the key pathway of thrombin generation, and require no routine coagulation function monitoring. It is mainly used for the prevention of venous thromboembolism after hip or knee replacement surgery. It can also be used for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, the treatment and recurrence prevention of deep vein thrombosis and pulmonary embolism. The applicable population covers multiple types of patients such as those in the perioperative period and patients requiring long-term anticoagulation for chronic diseases.

At present, the global market size of apixaban has exceeded 15 billion US dollars, and the sales volume at the terminal of China's public medical institutions has exceeded 6 billion yuan, with a compound annual growth rate of more than 18% in the past 3 years. In terms of the competitive landscape, the original research product still accounts for about 60% of the market share. More than 20 domestic enterprises have obtained approval for generic drug preparations, and apixaban has been included in the seventh batch of national centralized drug procurement. The winning bid price has a maximum reduction of more than 90% compared with the original research product. With the full expiration of patents, the market penetration rate of generic drugs is continuously increasing.

The original research of apixaban was jointly developed by Pfizer and Bristol-Myers Squibb, with the original brand name Eliquis. Its core compound patent expired in China in September 2022, and its crystal form patent will expire in 2026. The dosage form approved for the original research product is tablet, with specifications of 2.5mg and 5mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation recognized by the FDA. At present, the apixaban API of more than 30 Chinese enterprises has obtained A status through CDE registration, and there are more than 25 domestic manufacturers of apixaban tablets that have obtained approval, which can fully meet the production needs of downstream preparations. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of apixaban impurity reference standards. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully support the full-process needs of API R&D, quality research and compliance declaration.