Flecainide

Arrhythmia is a high-incidence chronic disease in the field of cardiovascular diseases. Among various types of arrhythmia, the long-term management of supraventricular tachycardia, premature ventricular contractions and other conditions has long been plagued by the pain point of limited clinical medication options. As a representative Class Ic antiarrhythmic drug, flecainide blocks the sodium channels of cardiomyocytes, inhibits the depolarization rate of phase 0 of the action potential, and prolongs the effective refractory period of myocardial conduction tissues. It is clinically mainly used to treat adult paroxysmal supraventricular tachycardia, paroxysmal atrial fibrillation, as well as symptomatic and sustained ventricular tachycardia. It can still demonstrate definite efficacy in patients who respond poorly to other antiarrhythmic drugs, and is currently one of the core options for second-line treatment of arrhythmia.

The global flecainide market size was approximately USD 420 million in 2023, with a compound annual growth rate of 4.8% from 2019 to 2023. The growth is mainly driven by the expansion of the chronic arrhythmia patient population and the increase in the penetration rate of primary diagnosis and treatment. The domestic market is still dominated by imported preparations at present, with few enterprises布局 generic drugs. As of 2024, only 3 enterprises have submitted marketing applications for generic flecainide preparations. The supply gap of active pharmaceutical ingredients (APIs) is relatively obvious, and flecainide has not yet been included in the national centralized volume procurement catalog, leading to a relatively loose market competition pattern.

The original developer of flecainide is 3M Company, with the original brand name Tambocor. The core compound patent in the US market expired in 2004, and the core compound patent in China expired in 2003. The main dosage forms of the original marketed product include tablets and injections. The tablet specifications are 50mg, 100mg and 150mg, and the injection specification is 10ml:100mg. The original tablets have been included in the FDA Reference Listed Drug Catalog and the China Catalog of Reference Preparations for Chemical Drugs. As of the search time point, there are a total of 5 flecainide API registration records on the domestic CDE API Registration Platform, among which 2 are in status A (approved for use in marketed preparations), and 8 enterprises have obtained domestic marketing approval for flecainide oral preparations. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of flecainide impurity reference standards, fully covering more than ten types of reference materials required for quality control such as 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. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the reference material needs in various stages such as API R&D, quality research, and registration declaration.