Dipyridamole

Thromboembolic diseases are the long-term focus of prevention and control in the cardiovascular field. As the core intervention for such diseases, antiplatelet drugs have always been the focus of clinical research, development and application. Dipyridamole is a phosphodiesterase inhibitor antiplatelet drug that exerts effects by inhibiting platelet aggregation and dilating coronary vessels. It is often used clinically in combination with aspirin to prevent thrombosis, and can also be used for secondary prevention of ischemic heart disease and stroke. It can also be used as an adjuvant anticoagulant for patients after heart valve replacement, covering the long-term medication needs of multiple departments such as cardiology and neurology.

At present, the global market size of dipyridamole is approximately US$470 million, and the compound annual growth rate in the past three years has remained at around 3.2%. The growth momentum mainly comes from the increasing demand for cardiovascular disease prevention and control in low- and middle-income countries. In terms of the domestic market, due to the early launch time and mature clinical application of this drug, the terminal price has dropped significantly after centralized procurement. The market competition is dominated by generic drug companies, and local enterprises account for more than 90% of the API supply share, with outstanding production cost advantages. In addition to meeting domestic demand, China is also one of the world's major exporters of dipyridamole.

The original research enterprise of dipyridamole is Boehringer Ingelheim, Germany, with the original brand name Persantin. The core compound patent expired worldwide in the 1980s. The main dosage forms of the original research product include 25mg and 75mg tablets, as well as 10mg/2mL injection. The original research tablets have been included in the FDA Reference Listed Drug Catalog, and the original research preparation has not been introduced in China yet. At present, the approved domestic preparations are mainly generic drugs. According to the domestic API registration platform, more than 15 enterprises have completed the A-status registration of dipyridamole APIs, which can meet the supply demand for domestic preparation production. (Data as of November 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of dipyridamole impurity reference standards. Most products are available in stock. Spot orders placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet various needs in the stages of API R&D, quality research and registration application.