Felbamate

Epilepsy is a common chronic neurological disease, and about 30% of patients will develop drug-resistant epilepsy, whose seizures are difficult to be controlled by conventional monotherapy. There is an urgent clinical demand for multi-target antiepileptic drugs. Felbamate is a new type of antiepileptic drug, which exerts its pharmacodynamic effect through the dual mechanisms of blocking N-methyl-D-aspartate receptors and enhancing γ-aminobutyric acid-mediated inhibitory effects. It is clinically mainly used as adjuvant therapy for refractory partial seizures in adults, and can also be used for seizure control of Lennox-Gastaut syndrome in children, providing a new medication option for epilepsy patients who do not respond to conventional treatment.

The global market size of antiepileptic drugs has exceeded 27 billion US dollars in 2024, among which the drug-resistant epilepsy segment maintains a compound annual growth rate of 6.2%. Due to its definite efficacy on refractory epilepsy, the market demand for felbamate keeps growing steadily. At present, the supply of generic drugs accounts for more than 85% in the global scope, and no domestic generic drug has been approved in the Chinese market. The clinical supply still relies on imports, leaving a large space for domestic substitution.

The original developer of felbamate is Medicis Pharmaceutical, with the original brand name Felbatol. Its core compound patent in the United States expired in 2002. The main dosage form of the original drug is tablet, with specifications including 400mg and 600mg, which has been included in the FDA Reference Listed Drug Catalog. Up to now, there is no approved registration number for felbamate active pharmaceutical ingredient in China, nor any felbamate preparation product approved for marketing in China. The clinical demand is mainly met through temporary import procurement. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity standards for felbamate active pharmaceutical ingredient. Most of the products are available in stock, and stock orders paid before 16:00 can be shipped on the same day. All products meet the regulatory requirements of multiple regions such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable impurity reference support for the R&D, registration and production processes of relevant pharmaceutical enterprises.