Mephenytoin

Epilepsy is a common chronic neurological disorder, with more than 70 million patients worldwide. Approximately 30% of patients have poor response to existing first-line anti-epileptic drugs, and there has been a long-term unmet clinical treatment demand. Mephenytoin is a hydantoin class anti-epileptic drug. It exerts anti-convulsant effects by blocking voltage-dependent sodium channels and reducing the high-frequency action potential discharge of neurons. Clinically, it is mainly used for the treatment of patients with generalized tonic-clonic seizures and partial seizures who are tolerant to phenytoin sodium or have insufficient response to it, and is particularly suitable for refractory epilepsy cases that are not ideally controlled by other drugs.

The current global market size of mephenytoin is relatively small. Restricted by the indication population and squeezed by new generation anti-epileptic drugs of the same category, its market growth rate has remained below 2% in recent years, and there is no publicly verifiable specific market size data. In terms of competitive landscape, this drug has a long history of clinical application, and there are no original research products on sale globally. The existing supply is dominated by small-scale generic drug manufacturers. Its domestic clinical usage is extremely low, and it has not been included in the national centralized volume-based procurement scope, with an overall low market competition degree.

Mephenytoin was originally developed by Abbott, with the original brand name Mesantoin. The core compound patent expired around 1970, and the original product has now been withdrawn from the global market. The main marketed dosage form is oral tablet, with common specifications of 50mg and 100mg. After retrieval, this variety is not included in the Reference Listed Drug Catalogue of marketed chemical drugs in China, nor is it included in the FDA Reference Listed Drug Catalogue. There is no domestic DMF information of mephenytoin API with a registration number obtained, nor is there any approved and marketed mephenytoin preparation product. (Data as of November 2024, please refer to the official website of CDE for the latest information)

In response to the demands for pharmaceutical research and generic drug development of mephenytoin, CATO can provide a full set of impurity reference standards for this API. Most products support spot supply. For in-stock products, orders placed before 16:00 can be delivered on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the demands of various R&D scenarios such as quality research, qualitative and quantitative analysis of impurities.