Pitofenone

As a novel selective P2Y12 receptor antagonist, piltrogrel belongs to the third-generation antiplatelet drug category. It reversibly blocks the P2Y12 receptor on the surface of platelets to inhibit adenosine diphosphate-mediated platelet aggregation. Compared with traditional thienopyridine drugs, it has a faster onset of action and lower bleeding risk. It is mainly used for antithrombotic therapy in patients with acute coronary syndrome, covering the adult population receiving conservative medical treatment and percutaneous coronary intervention, and can significantly reduce the risk of composite endpoint events including cardiovascular death, myocardial infarction and stroke.

At present, the global market size of antiplatelet drugs has exceeded 10 billion US dollars, among which the proportion of novel P2Y12 receptor antagonists is increasing year by year, with a compound annual growth rate maintained at around 8%. As the latest marketed variety in this category, piltrogrel is currently in the market introduction stage. Since there are no generic products during the patent protection period, the global market is exclusively supplied by the original research enterprise; there are no generic drug application records in China, and the market demand is mainly dependent on imports, with considerable market expansion space.

The original research enterprise of piltrogrel is the Japanese pharmaceutical company Daiichi Sankyo, and the original trade name is Pletalta. Its core compound patent expires in 2029 in Japan, and the core compound patents for the US and Chinese markets expire in 2031. The main dosage form currently on the market is oral tablet, with specifications of 20mg and 40mg. The original research tablets have been included in the drug list of the Ministry of Health, Labour and Welfare of Japan and the FDA Orange Book Reference Listed Drug Catalog. There are no registered DMF numbers for piltrogrel API in China, nor are there any approved domestic or imported preparation products on the market. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the demand for impurity reference standards in the process of process development, quality research and generic drug declaration of this variety, CATO provides a full set of piltrogrel impurity reference standards. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet various application scenarios in the links of pharmaceutical R&D and quality control of pharmaceutical enterprises.