Fosinopril

As an important variety of angiotensin-converting enzyme inhibitor (ACEI) antihypertensive drugs, fosinopril exerts a long-acting antihypertensive effect of dilating blood vessels and reducing peripheral resistance by inhibiting the activity of angiotensin-converting enzyme, reducing the production of angiotensin II, and slowing down the degradation of bradykinin. Different from most similar drugs, fosinopril has the characteristic of dual excretion via liver and kidney, so patients with mild to moderate hepatic and renal insufficiency do not need to adjust the dosage, with remarkable safety advantages. In addition to the clinical treatment of various types of hypertension, it can also improve ventricular remodeling in patients with heart failure and reduce the recurrence risk of cardiovascular events, especially suitable for elderly hypertensive patients with combined hepatic and renal function injury.

At present, the global market size of antihypertensive drugs has exceeded 35 billion US dollars. ACEIs, with their definite target organ protective effect, account for about 12% of the market share. As a representative variety of the third-generation ACEIs, fosinopril has maintained a global market compound annual growth rate of 4.2% in the past three years. In the domestic market, the sales of fosinopril preparations in sample hospitals exceeded 320 million yuan in 2023. Currently, the original research product still accounts for nearly 60% of the market share, and 8 domestic enterprises have been approved for generic preparation, among which 4 products have passed the consistency evaluation. In the third batch of national centralized drug procurement, the average winning bid price of fosinopril sodium tablets decreased by 73% compared with that before the centralized procurement. With the implementation of the centralized procurement, the market penetration rate of generic drugs is continuously increasing.

The original research enterprise of fosinopril is Bristol-Myers Squibb, with the original brand name "Monopril". Its core compound patent expired in both China and the United States in 2008. At present, the main dosage form approved in China is fosinopril sodium tablets, with a conventional specification of 10 mg. The original dosage form has been included in the China Listed Drug Catalogue as a reference preparation, and is also included in the FDA Reference Preparation Catalogue. In terms of API registration, a total of 7 fosinopril sodium API registration information has been published on the CDE platform, among which 2 are in status A (approved for use in domestic marketed preparations) and 5 are in status I. There are 9 domestic approval documents for fosinopril sodium tablets, and both original research and generic drugs have been marketed in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of fosinopril impurity reference standards, covering all research dimensions such as process impurities and degradation impurities. Most products are available from stock, and in-stock orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of pharmaceutical regulatory regulations of various countries such as the Chinese Pharmacopoeia and FDA, and can fully meet the relevant needs of enterprises in API quality research, consistency evaluation and registration declaration.