Isosorbide Dinitrate

Cardiovascular diseases are one of the types of chronic diseases with the highest mortality rate in the world. As core medications for anti-myocardial ischemia, vasodilator drugs occupy an irreplaceable position in clinical treatment. Isosorbide dinitrate is a nitrate vasodilator. It activates guanylate cyclase by releasing nitric oxide, relaxes vascular smooth muscle, dilates peripheral arteries and veins, reduces myocardial oxygen consumption, and improves the blood flow distribution in myocardial blood supply areas at the same time. Clinically, it is mainly used for the long-term treatment of coronary heart disease, the prevention of angina pectoris, and the treatment of persistent angina pectoris after myocardial infarction. It can also be used in combination with digitalis and diuretics to treat chronic congestive heart failure. The applicable population covers patients with coronary heart disease, angina pectoris and heart failure of all age groups.

At present, the global market size of isosorbide dinitrate is approximately USD 420 million, with an annual compound growth rate maintained at around 2.8%, and the domestic market size is approximately RMB 1.2 billion. Since this drug has been on the market for a long time and its patents have long expired, the global market is dominated by generic drugs. China is the main producer of isosorbide dinitrate API, with production capacity accounting for more than 65% of the global total. The domestic preparation market has been included in multiple rounds of national centralized procurement, and the winning bid price has dropped by more than 70% compared with that before the centralized procurement, which further improves the accessibility of the drug, and the annual growth rate of grassroots clinical dosage remains at around 8%.

The original research enterprise of isosorbide dinitrate is Boehringer Ingelheim of Germany, and the original research brand name is "Xiaoxintong" (Isordil). Its core compound patent expired globally in the 1980s. The main dosage forms approved for the original research include tablets, sustained-release tablets and injections. Common specifications are 5mg and 10mg conventional tablets, 20mg and 40mg sustained-release tablets, as well as 10ml:10mg injection. The original research preparations have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and are also included in the FDA Reference Preparation Catalogue. Up to now, there are 22 registration entries of isosorbide dinitrate API on China CDE API Registration Platform, among which 16 are in status A and can be legally supplied to preparation manufacturers for use. More than 30 domestic enterprises have obtained marketing approval for isosorbide dinitrate preparations. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for isosorbide dinitrate. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the impurity reference requirements in the process of API R&D, quality research and production.