Fenoldopam

In intensive care scenarios, the rapid blood pressure reduction for malignant hypertension and postoperative hypertension has long been an unmet clinical demand. As a highly selective dopamine D1 receptor agonist, fenoldopam can lower blood pressure by dilating peripheral blood vessels such as renal arteries and coronary arteries, while increasing renal blood flow and improving glomerular filtration rate. Compared with traditional antihypertensive drugs, it does not cause renal function damage, and is particularly suitable for patients with hypertensive crisis complicated by renal insufficiency, as well as for the short-term control of perioperative hypertension in cardiac surgery and non-cardiac surgery. It is currently one of the few intravenous antihypertensive drugs that have both blood pressure lowering and renal protective effects.

The current global market size of fenoldopam is approximately USD 120 million, with a compound annual growth rate of 4.8% in the past three years, and the growth is mainly driven by the increasing demand for perioperative hypertension management. The domestic market is still in a rapid expansion stage. In 2023, the sales volume in domestic sample hospitals exceeded RMB 92 million, with a year-on-year growth of 17.3%. In terms of competitive landscape, there are no domestic generic drugs launched in China yet, and the market has been dominated by the original research product for a long time. With the large gap in clinical demand, the development progress of generic drugs related to centralized procurement has become a core variable of concern in the industry.

The original research enterprise of fenoldopam is Hospira, Inc., and the original brand name is Corlopam. Its core compound patent in the United States expired in 2005, and all core patents in China expired in 2014. The main dosage form of the original research product is injection, with a specification of 10mg/5ml, which has been included in the FDA Reference Listed Drug Catalog. At present, there is no marketed original research preparation in China. There are 3 registered API DMFs in total, all of which are A-status registration numbers declared by domestic enterprises, and no domestic preparation varieties have been approved. (Data as of September 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of fenoldopam 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. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully support the quality control requirements in the whole process of generic drug research and development, quality research and marketing application.