Losartan

Hypertension is the chronic cardiovascular disease with the highest prevalence worldwide. Poor long-term control of hypertension easily leads to severe complications such as myocardial infarction, stroke and renal failure, and there is an urgent clinical demand for safe and long-acting antihypertensive drugs. Losartan is an angiotensin Ⅱ receptor antagonist (ARB) class antihypertensive drug. It highly selectively blocks the binding of angiotensin Ⅱ to AT1 receptors, inhibits vasoconstriction and aldosterone release, thereby steadily lowering blood pressure. Meanwhile, it can also reduce urinary protein excretion and delay the progression of renal damage. In addition to patients with essential hypertension, it is especially suitable for hypertensive populations with comorbid diabetic nephropathy and left ventricular hypertrophy, and is a first-line therapeutic drug recommended by hypertension guidelines in many countries.

The global market size of losartan is approximately USD 1.2 billion. In recent years, with the increase in the prevalence of hypertension and the expansion of the patient population with comorbidities, the market maintains a compound annual growth rate of 3.2%. In terms of the domestic market, the annual sales of losartan at public medical institution terminals exceed RMB 1.8 billion, among which the original research product accounts for about 41% of the market share, and the remaining share is divided by more than 20 domestic generic drug manufacturers. This variety has been included in the national centralized drug procurement, and the price of the winning preparations has dropped by more than 90%, directly driving the continuous increase in demand for upstream APIs. At present, domestic API manufacturers are mainly concentrated in East China and South China, and their production capacity accounts for more than 65% of the total global supply.

The original research enterprise of losartan is Merck Sharp & Dohme, and the original brand name is Cozaar. Its core compound patent expired globally in 2010, and the preparation patent in China also expired in 2012. The main dosage form approved by the original research is tablet, with specifications of 50mg and 100mg, which have been included in the Chinese *Catalogue of Reference Preparations for Chemical Drugs* and the FDA Reference Preparation Catalogue. Up to now, the Center for Drug Evaluation of China has publicized more than 30 losartan API registration numbers, most of which are in A status and can be used for associated review. Nearly 30 domestic enterprises have obtained approval for the marketing of preparations such as losartan potassium tablets and losartan potassium hydrochlorothiazide tablets. (Data as of September 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of losartan impurity reference standards. Most products are in stock, and stock products ordered before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the demand for impurity reference standards in the process of API R&D, quality research and production.