Eprosartan

Excessive activation of the renin-angiotensin-aldosterone system is one of the core pathological mechanisms for the progression of hypertension. As a highly selective angiotensin Ⅱ receptor antagonist (ARB class), eprosartan can specifically block the AT1 receptor subtype, inhibit vasoconstriction and reduce aldosterone release. While achieving stable blood pressure lowering, it does not cause the adverse reaction of dry cough related to bradykinin accumulation, so it is more suitable for hypertension patients who are intolerant to ACEI drugs. In addition to the treatment of essential hypertension, this drug can also reduce the risk of cardiovascular events in hypertension patients with renal function injury and type 2 diabetes mellitus, and has a definite protective effect on target organs, making it a commonly used basic drug in clinical hypertension combination therapy regimens.

Driven by the year-by-year increase in the global prevalence of hypertension, the ARB class antihypertensive drug market has maintained a stable growth trend for a long time. Latest data shows that in 2023, the global market size of ARB class drugs exceeded 14 billion US dollars. Among them, eprosartan accounts for approximately 3% of the细分 market share due to its tolerance advantage, and its compound annual growth rate in the past three years has remained at around 2.8%. In terms of the domestic market, this variety has not yet been included in the national centralized volume-based procurement. At present, the supply is dominated by imported original research preparations, the number of generic drug declaration enterprises is small, and the supply gap of active pharmaceutical ingredients is relatively obvious. The market space is expected to be further released after the domestic generic drugs are launched in the future.

The original research enterprise of eprosartan is Boehringer Ingelheim, and the original research brand name is Teveten. Its core compound patent expired globally in 2009. The main dosage form approved for the original research is tablet, with specifications of 400mg and 600mg. This original research tablet has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs* of China. At present, there are no approved eprosartan preparation products marketed in China, and there is no Class A or Class I API registration number in valid status on the CDE API registration platform either. The domestic declaration of related varieties is still in the early stage. (Data as of October 2024, please refer to the official CDE website for the latest information.)

CATO provides a full set of eprosartan impurity reference standards, covering process impurities, degradation impurities and isomer impurities. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most products are kept in stock permanently, and orders placed before 16:00 can be shipped on the same day, which can fully meet the sample supply needs of the whole process of API R&D, quality research and generic drug declaration.