Olmesartan

Hypertension is one of the chronic cardiovascular diseases with the highest prevalence worldwide. Angiotensin Ⅱ receptor antagonists (ARB) are a category of first-line antihypertensive drugs at present. As a variety with longer duration of action and stronger receptor affinity in this category, olmesartan blocks AT₁ receptors with high selectivity, inhibits vasoconstriction and aldosterone release, so as to achieve a stable and long-lasting antihypertensive effect. Its indications cover essential hypertension. It can be used as monotherapy for patients with mild to moderate hypertension, and can also be combined with calcium channel blockers, diuretics, etc. for the treatment of refractory hypertension. It can also provide additional target organ protection for hypertension patients with diabetes mellitus and chronic kidney disease, and has high clinical recognition.The global olmesartan market size has maintained a steady growth trend in recent years. In 2023, the overall market size was approximately USD 1.87 billion, with the Chinese market accounting for nearly 35%. As the core patents expire, the market share of generic drugs continues to rise. More than 20 domestic enterprises have obtained approval for olmesartan preparations. After the volume-based procurement, the terminal price has dropped by more than 80%, which has greatly improved the accessibility of primary-level medication. The annual growth rate of domestic demand for API is maintained at around 12%. East China and North China are the core production clusters of olmesartan API in China.The original research enterprise of olmesartan is Daiichi Sankyo Pharmaceutical, with the original brand name "Benicar". Its US compound patent expired in 2016, and its Chinese compound patent expired in 2010. The main dosage form approved in China is 20mg tablets, and the 40mg specification has been approved for marketing in European and American markets. The original 20mg tablet has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation announced by the FDA. Up to now, more than 30 registration information for olmesartan API marketing can be queried on the CDE platform, of which more than 20 are in Status A and can be supplied for domestic preparation production. A number of preparation varieties such as olmesartan medoxomil tablets and olmesartan medoxomil and amlodipine tablets have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)CATO provides a full set of impurity reference standards for olmesartan API, covering all types of impurities such as synthesis process impurities and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of pharmaceutical enterprises in quality research, consistency evaluation and routine production quality control.

全球奥美沙坦市场规模近年保持稳定增长态势，2023年整体市场规模约18.7亿美元，中国市场占比接近35%。随着核心专利到期，仿制药市场份额持续攀升，国内已有超过20家企业获批奥美沙坦制剂，带量采购后终端价格降幅超过80%，带动基层用药可及性大幅提升，国内原料药需求年增速维持在12%左右，华东、华北地区是国内奥美沙坦原料药的核心生产集聚区。

奥美沙坦原研企业为第一三共制药，原研商品名为“傲坦”，其美国化合物专利于2016年到期，中国化合物专利于2010年到期，国内获批的主要剂型为20mg片剂，另有40mg规格在欧美市场获批上市。原研20mg片剂已列入中国《化学药品参比制剂目录》，同时为FDA公布的参比制剂。截至目前，CDE平台可查询到超过30条奥美沙坦原料药上市登记信息，其中超过20条为A状态，可供应国内制剂生产，国内已有奥美沙坦酯片、奥美沙坦酯氨氯地平片等多个制剂品种获批上市。（数据截至2025年6月，最新请以CDE官网为准）

CATO/佳途科技提供奥美沙坦API全套杂质标准品，覆盖合成过程杂质、降解杂质等全类型，大部分产品现货供应，现货产品16:00前下单当天发货，符合中国药典、FDA等多法规合规要求，可充分满足药企质量研究、一致性评价及常规生产质控的全流程需求。