Nebivolol

Cardiovascular disease is the leading cause of death globally. Among them, hypertension, as the most common chronic underlying cardiovascular disease, has a patient population of more than 1.2 billion. Nebivolol is a third-generation highly selective β1 receptor blocker with a dual mechanism of action of β1 receptor blockade and nitric oxide-mediated vasodilation. It can not only effectively lower blood pressure and slow down heart rate, but also reduce the adverse effects on glucose and lipid metabolism and sexual function, and improve left ventricular function. It is suitable for patients with essential hypertension of all age groups, and can also be used for adjuvant treatment of chronic stable heart failure, especially for hypertensive patients with comorbid diabetes and dyslipidemia.

The global market size of nebivolol is approximately USD 870 million, maintaining a compound annual growth rate of 4.2% in recent years. Its market growth mainly comes from the increased penetration of chronic disease management and the growing demand of patients for highly selective antihypertensive drugs. In terms of competitive landscape, the original research product still accounts for nearly 60% of the share in the high-end markets of Europe and the United States, while generic drugs are rapidly penetrating into emerging markets such as India and China. At present, 10 domestic enterprises have obtained approval for nebivolol generic drug preparations. After centralized procurement, the price has dropped by more than 85%, and the accessibility at the primary level has been greatly improved.

The original research enterprise of nebivolol is Johnson & Johnson of the United States, and the original research trade name is Bystolic. Its core compound patent in the United States expired in 2021, and the compound patent in China expired in 2017. The main dosage form of the original research product is tablet, with specifications including 2.5mg, 5mg, 10mg and 20mg. It has been included in the FDA Reference Listed Drug Catalog, and also included in China's *Catalog of Reference Preparations for Chemical Drugs*. Up to now, there are 12 registration entries of nebivolol API on the CDE API registration platform, among which 8 are in A status, and multiple domestic enterprises have obtained marketing approval for nebivolol tablets. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of nebivolol impurity reference standards, covering the whole chain of reference materials including synthetic starting materials, intermediates and degradation impurities. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can meet the use needs of different scenarios such as API R&D, quality research, registration and declaration.