Apixaban API and Tablet Process Transfer
Basic Information
Name: Apixaban
Dosage Form: Tablet
Specification: 2.5 mg, 5 mg
Indication: For adult patients undergoing elective hip or knee replacement surgery to prevent venous thromboembolism (VTE).
Dosage and Administration: The recommended dose is 2.5 mg taken orally twice daily with water, unaffected by meals. The first dose should be taken 12 to 24 hours after surgery. When determining the exact timing within this window, physicians should consider both the potential benefits of early anticoagulation for VTE prevention and the risk of postoperative bleeding.
For patients undergoing hip replacement surgery: Recommended treatment duration is 32 to 38 days.
For patients undergoing knee replacement surgery: Recommended treatment duration is 10 to 14 days.
Chemical Structure:
[Structure not provided in text]
Molecular Formula: C25H25N5O4
Molecular Weight: 459.50
CAS Number: 503612-47-3
Market Status: Jointly developed by Pfizer and Bristol-Myers Squibb, launched in the EU in 2011, in the United States on December 28, 2012, and in China in 2013.
Patent Status:
Compound Patent: CN1578660, expires on February 9, 2025
Formulation Patent: CN102770126, expires on February 24, 2031
Market Prospects:
Despite significant scientific advancements, cardiovascular diseases remain the leading cause of death globally. The prevention and research of thrombotic cardiovascular diseases are among the urgent issues to be addressed. Surveys indicate that approximately 1 billion people worldwide suffer from thrombotic diseases, with a prevalence rate as high as 23%, particularly increasing significantly among the elderly, reaching up to 44%. Antiplatelet drugs, enzyme inhibitors, and various antagonist drugs are currently the main treatments for thrombotic diseases. With research on Factor Xa inhibition mechanisms, the proportion of direct oral medications has increased, demonstrating excellent therapeutic efficacy.
From the current domestic drug market, it is evident that most antithrombotic drugs are imported, with fewer domestic drugs, most of which are generics.
Apixaban, as a Factor Xa inhibitor, is being actively developed by numerous pharmaceutical companies and institutions both domestically and internationally. In recent years, as a newly marketed oral drug, it has the potential to replace traditional oral and injectable drugs, becoming a primary medication for clinical anticoagulation therapy. This class of drugs has broad application prospects.
Synthetic Route:
