Clopidogrel

Cardiovascular and cerebrovascular diseases have become the leading cause of death globally. Antiplatelet therapy is the core regimen for the prevention and treatment of such diseases, and clopidogrel is the most widely used thienopyridine P2Y12 receptor antagonist in this field. It irreversibly inhibits the ADP receptors on platelet membranes, blocks the key pathway of platelet aggregation, and reduces the risk of thrombosis. Clinically, it is mainly used for the secondary prevention of patients with acute coronary syndrome, ischemic stroke, and peripheral arterial disease. It can also be used for patients after percutaneous coronary intervention (PCI) to reduce the occurrence of in-stent thrombosis and adverse cardiovascular events. The applicable population covers various patients with atherosclerotic diseases from middle age to old age.

At present, the global annual market size of clopidogrel is approximately USD 9 billion, and the annual sales in the Chinese market exceed RMB 12 billion, making it a core drug in the antiplatelet field. With the continuous increase in the global prevalence of cardiovascular and cerebrovascular diseases and the popularization of primary diagnosis and treatment, the market maintains a compound annual growth rate of around 3%. In terms of the competitive landscape, the original research product accounts for about 30% of the Chinese market share, and there are more than 20 domestic generic drug enterprises. Among them, the preparations of multiple enterprises have passed the consistency evaluation. After the centralized procurement, the drug price has dropped by more than 80%, and the accessibility for patients has been greatly improved. The upstream API production capacity is mainly concentrated in China and India, and there are more than 15 domestic API manufacturers with stable supply.

The original research enterprise of clopidogrel is Sanofi, and the original brand name is Plavix. Its core compound patent expired in major markets in 2012, and the crystal form patent in China also expired in 2019. The main dosage forms approved for the original research are tablets, with specifications of 75mg and 300mg. The original research product has been included in the *Catalogue of Reference Preparations of Chemical Drugs* in China, and is also a reference preparation listed by the FDA. At present, there are more than 50 domestic clopidogrel API registration numbers, most of which are in status A and can be used for associated preparation declaration. The domestically approved clopidogrel preparations on the market include tablets, capsules, etc., and multiple brands have achieved commercial supply. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of clopidogrel impurity reference standards, covering the full spectrum of products including starting material impurities, intermediate impurities, and degradation impurities in the synthesis process. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully comply with the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of API enterprises for quality research, impurity calibration, and registration declaration.