Vigabatrin

As an important clinical option for the treatment of refractory epilepsy, vigabatrin is a γ-aminobutyric acid (GABA) analog antiepileptic drug. It irreversibly inhibits GABA transaminase to increase the concentration of the inhibitory neurotransmitter GABA in the central nervous system, thereby reducing neuronal excitability and decreasing the frequency of epileptic seizures. This drug is the first-line treatment for infantile spasms (West syndrome), and is also used as adjunctive therapy for refractory partial-onset seizures in adults and children. It has clear clinical value especially for patients who respond poorly to conventional antiepileptic drugs.

At present, the global market size of vigabatrin is approximately USD 420 million, with a compound annual growth rate of 3.1% in the past three years. The growth momentum mainly comes from the increased diagnosis rate of epilepsy in the rare disease field and the popularization of the first-line medication recommendation for infantile spasms in clinical guidelines. The Chinese market is still in the introduction stage. In 2023, the sales of vigabatrin in domestic sample hospitals exceeded RMB 32 million, with a year-on-year growth rate of 78%. The current competitive landscape is relatively concentrated: the original research product accounts for more than 85% of the market share, only 3 domestic pharmaceutical companies have submitted marketing applications for generic drugs, and vigabatrin has not been covered by centralized procurement yet.

The original developer of vigabatrin is Sanofi, with the original brand name Sabril. Its compound patent in the US market expired in 2017, and the core compound patent in China expired in 2022. The originally marketed dosage forms include tablets (500 mg) and powder for oral solution (500 mg per sachet), which have been included in the FDA Orange Book Reference Listed Drug Catalog, and are also reference listed drugs marketed in China. Up to now, there are 6 pieces of vigabatrin API registration information on the API Registration Platform of China CDE, among which 2 are in status A and can be used in conjunction with preparation declaration. 2 domestic enterprises have obtained marketing approval for their generic vigabatrin preparations. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the R&D and quality control needs of vigabatrin, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet various compliance needs of drug R&D, quality research and routine release testing.