Ibutilide

Arrhythmia is a common clinical cardiovascular disease. Among them, rapid atrial arrhythmias such as atrial fibrillation and atrial flutter, if not intervened in time, may significantly increase the risk of thromboembolism and heart failure. As a representative variety of Class III antiarrhythmic drugs, ibutilide selectively blocks the potassium channels of cardiomyocytes, prolongs the action potential duration and effective refractory period, and has unique clinical advantages in rapidly cardioverting newly onset atrial fibrillation and atrial flutter. It is especially suitable for patients with poor cardioversion effect of other drugs, and is a common choice for rapid management of atrial arrhythmia in emergency departments and cardiology departments.

Data show that the domestic market size of antiarrhythmic drugs has exceeded 8 billion yuan, among which the proportion of Class III drugs is increasing year by year, with a year-on-year growth rate of 12.7% in 2023. As a segmented variety with the characteristics of fast onset and high cardioversion rate, ibutilide is currently mainly supplied by generic drugs in the domestic market. The winning bid price has dropped from nearly 300 yuan per unit at the initial stage to about 30 yuan after centralized procurement, with greatly improved clinical accessibility, and there is still considerable room for growth in the penetration rate of the primary market.

The original developer of ibutilide is Pharmacia & Upjohn, and the original brand name is Corvert. Its U.S. patent expired in 2009. The original dosage form is injection with a specification of 10ml:1mg, which has been included in the FDA Reference Listed Drug Catalog. At present, ibutilide injections from a number of domestic enterprises have been approved for marketing. In terms of APIs, a number of enterprises have obtained A-status registration numbers, which can meet the domestic production demand of preparations. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the R&D and quality control needs of ibutilide, CATO can provide a full set of impurity reference standards for this API. Most of the products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide reliable material basis support for relevant enterprises in impurity research, quality standard establishment and stability investigation.