Pimobendan

Chronic heart failure is a cardiovascular disease with high incidence worldwide. Conventional positive inotropic drugs tend to increase myocardial oxygen consumption and induce arrhythmias, and there has been a long-standing gap in safe clinical medication. Pimobendan is a positive inotropic drug belonging to the calcium sensitizer class, which differs from the mechanism of action of traditional digitalis drugs. It exerts a positive inotropic effect by increasing the sensitivity of myocardial myofilaments to calcium ions, and also has a phosphodiesterase Ⅲ inhibitory effect to dilate blood vessels. It enhances myocardial contractility without significantly increasing myocardial oxygen consumption. It is mainly used for the short-term treatment of acute decompensated heart failure, and is also suitable for patients with acute exacerbation of chronic heart failure, which can effectively reduce the risk of rehospitalization of patients.

At present, the global market size of pimobendan is approximately USD 420 million, with a compound annual growth rate maintained at around 7.8%. The growth momentum mainly comes from the rising prevalence of heart failure and the increasing clinical demand for the safety of positive inotropic drugs. The domestic market is still in the introduction stage, and it has long relied on imported preparations previously. With the acceleration of generic drug R&D progress, the market growth rate has remained above 15% in the past three years, and the competitive landscape is relatively relaxed. Currently, only 3 enterprises have obtained approval for their generic preparations to be marketed, and the gap in API supply is relatively obvious.

The original research enterprise of pimobendan is Teva Pharmaceutical, with the original brand name "Primacor". The expiration time of its core compound patent in major markets such as the European Union and the United States is 2021, and the compound patent in China expired in 2019. The main dosage form approved for the original drug is injection, with a specification of 10mg/10ml. It has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs (Third Batch)* of China. Up to now, there are a total of 7 pimobendan API registration records on the API registration platform of China CDE, among which 3 are in the status of "A" (approved for use in marketed preparations). There are 6 generic preparation varieties approved for marketing in China, covering two dosage forms: injection and oral solution. (Data as of June 2025, please refer to the official website of CDE for the latest information.)

CATO can provide a full set of pimobendan impurity reference standards. Most of the 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 provide stable and reliable reference standard support for the quality research and consistency evaluation work of API and preparation enterprises.