Fampridine

Multiple sclerosis is a chronic inflammatory demyelinating neurodegenerative disease of the central nervous system. Approximately 80% of patients will develop varying degrees of walking dysfunction after onset, which severely affects their quality of life. Dalfampridine is a potassium channel blocker for nervous system disorders. It can block potassium channels on demyelinated axons, prolong the duration of action potential, and improve nerve impulse conduction. Clinically, it is mainly used to improve the walking ability of patients with multiple sclerosis. It is the first treatment drug approved worldwide targeting this symptom, filling the long-standing gap in the field of symptomatic treatment for multiple sclerosis.

The global market size related to dalfampridine was approximately USD 420 million in 2023. Driven by the increasing prevalence of multiple sclerosis year by year and the rising demand of patients for function-improving drugs, it is expected to maintain a compound annual growth rate of 4.1% from 2024 to 2030. The current market is dominated by the original research product, with generic drugs accounting for less than 25%. In the domestic market, only the original research product and a small number of approved generic drugs are available at present. With the improvement of clinical awareness and the expansion of medical insurance coverage, the growth rate of domestic demand is expected to be higher than the global average.

The original research enterprise of dalfampridine is Acorda Therapeutics, and the original research trade name is Ampyra. Its core compound patent in the United States expired in 2018, and the core patent in China will expire in 2027. The main dosage form of the original research product is sustained-release tablet with a specification of 10 mg, which has been included in the FDA Reference Listed Drug Catalog, and also included in the *Chinese List of Chemical Drugs*. Up to now, there is no registered A-status registration number for dalfampridine API in China, and 3 domestic enterprises have obtained marketing approval for dalfampridine sustained-release tablets. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for dalfampridine API. Most products are available in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs in various stages including API R&D, quality research, and consistency evaluation.