Sotalol

Arrhythmia is a common clinical cardiovascular disease, among which ventricular arrhythmia has a high risk of death. For a long time, there has been an urgent clinical need for broad-spectrum antiarrhythmic drugs with both safety and efficacy. Sotalol is a class III antiarrhythmic drug, which also has non-selective β-receptor blocking effect. It exerts its effect by prolonging the duration of myocardial action potential and slowing down the conduction velocity. It is not only applicable to ventricular arrhythmias such as ventricular premature beats and sustained ventricular tachycardia, but also can be used for the treatment of supraventricular arrhythmias such as atrial fibrillation and atrial flutter. It is an important clinical option for arrhythmia patients with underlying diseases such as coronary heart disease and hypertension.

At present, the global market size of antiarrhythmic drugs is growing steadily. In 2023, the global market size of sotalol-related preparations was approximately USD 210 million, and the market size in China was approximately RMB 120 million, with a compound annual growth rate of around 6% in the past three years. In terms of competitive landscape, the domestic preparation market has formed a situation where both original drugs and generic drugs are supplied. Generic drugs from more than 10 enterprises have been approved for marketing, and this variety has been included in multiple batches of national centralized volume-based procurement, with the price of winning bids reduced by more than 70%, which has driven the continuous increase in demand for high-cost-effective APIs from downstream preparation enterprises.

The original developer of sotalol is Bristol-Myers Squibb from the United States, with the original brand name Betapace. Its core compound patent in the United States expired in 1999, and the compound patent in China has also expired. The mainstream dosage forms of the original drug include tablets and injections. The specifications of tablets are 80mg, 120mg and 160mg, and the specification of injection is 10ml:120mg. The original tablets have been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. In terms of domestic API registration, more than 8 enterprises have obtained approval for the registration of sotalol APIs with the status of A. At the same time, multiple preparation varieties such as sotalol hydrochloride tablets and sotalol hydrochloride for injection have been approved for marketing in China. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for sotalol API. Most products are available from stock. Spot orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, which can fully meet the use needs of reference standards in the process of API R&D, quality research and routine production, and provide stable support for the compliant R&D and production of enterprises.