Dobutamine

As the terminal stage of cardiovascular diseases, heart failure often requires rapid improvement of the hemodynamic status of patients in clinical practice. Dobutamine is a typical representative of β-adrenoceptor agonist positive inotropic drugs. It can selectively stimulate cardiac β₁ receptors, enhance myocardial contractility and increase cardiac output, while having little impact on heart rate and rarely causing adverse reactions such as tachycardia. It is mainly used for heart failure caused by organic heart diseases and low cardiac output syndrome after cardiac surgery, and can also be used as an adjuvant therapeutic drug for shock, applicable to adult patients and pediatric patients requiring short-term positive inotropic support.

At present, the global market size of dobutamine is approximately USD 210 million, with a compound annual growth rate of around 3.2% in the past three years. The growth momentum mainly comes from the rigid clinical demand driven by the rising prevalence of chronic heart failure. In terms of the domestic market, the annual sales volume in public hospitals is stable at more than RMB 800 million. The market is dominated by generic drugs, with no original research products available for sale currently. The concentration of domestic manufacturers is relatively high, with the top 3 enterprises accounting for more than 65% of the market share. This variety has been included in the centralized procurement of multiple provinces, and the price reduction of the selected products is approximately 42%, which has greatly improved clinical accessibility.

The original research enterprise of dobutamine is Eli Lilly and Company, with the original trade name Dobutrex. The core compound patent in the United States expired in 1989. The main dosage form approved for the original product is injection, with specifications including 20mg/2ml and 250mg/20ml. The original product has been included in the FDA Reference Listed Drug Catalog, but not included in the Chinese Reference Listed Drug Catalog. Up to now, a total of 22 dobutamine API filing information have been registered on the domestic CDE platform, of which 17 are in status A (already used in marketed preparations). The domestically approved dobutamine preparations include two dosage forms: dobutamine hydrochloride injection and dobutamine hydrochloride for injection. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of dobutamine impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of API manufacturers for quality research, stability study and registration declaration.