Prasugrel

For patients with acute coronary syndrome after percutaneous coronary intervention, thrombotic events are the core risk affecting prognosis. As a third-generation thienopyridine P2Y12 receptor antagonist, prasugrel irreversibly inhibits the ADP receptor on the platelet surface and blocks the platelet aggregation pathway. Compared with clopidogrel, it has a faster onset of action and stronger inhibitory effect, and is especially suitable for patients with ST-segment elevation myocardial infarction and high-risk non-ST-segment elevation acute coronary syndrome who require rapid antithrombotic therapy. It can significantly reduce the risk of the composite endpoint of cardiovascular death, myocardial infarction and stroke, and has now become a first-line antiplatelet drug recommended by domestic and foreign guidelines.

The global market size of prasugrel was approximately USD 1.27 billion in 2023, with a compound annual growth rate of 3.2% in the past five years. The growth momentum mainly comes from the improvement of the diagnosis and treatment rate of acute coronary syndrome in emerging markets. In terms of the domestic market, as relevant antithrombotic drugs are included in the centralized procurement, the penetration rate of generic preparations continues to rise. The domestic market size of prasugrel preparations was approximately RMB 210 million in 2023. At present, more than 10 enterprises have obtained approval documents for generic preparations, and the market competition has gradually shifted from the pattern dominated by the originator to a pattern with the joint participation of multiple generic enterprises, and the demand for upstream API has steadily increased accordingly.

Prasugrel was originally developed by Daiichi Sankyo and Eli Lilly and Company, with the original brand name "Effient" (Chinese brand name "Weixinde"). Its core compound patent expired in 2023 in the United States and in 2022 in China. The main dosage form approved for the original product is oral tablet, with two specifications of 5mg and 10mg, which has been included in the FDA Reference Listed Drug Catalog and the Chinese *Catalog of Reference Preparations for Chemical Drugs*. In terms of domestic API registration, at present, prasugrel APIs from 5 enterprises including the originator have completed registration with the CDE, all with the status of A, and more than 15 domestic enterprises have obtained marketing approval for prasugrel preparations. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for prasugrel API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products comply with the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the full-process R&D and production quality control needs of API enterprises such as quality research, impurity localization, and stability investigation.