Lamotrigine

As a first-line antiepileptic drug commonly used in clinical practice, lamotrigine is a phenyltriazine class sodium channel blocker. It can reduce the release of pathological glutamate by inhibiting voltage-dependent sodium channels, and simultaneously regulate the activity of calcium channels to stabilize the overexcited nerve cell membranes. Its indications cover partial seizures and generalized tonic-clonic seizures in adults and children aged 2 years and above. It can also be used for maintenance treatment of bipolar disorder, and is particularly suitable for patients with combined cognitive function impairment or poor tolerance to traditional antiepileptic drugs, greatly reducing the seizure frequency and disease burden of epilepsy patients.

In recent years, the global market size of lamotrigine has stabilized at around 1.8 billion US dollars, and the annual growth rate of the Chinese market has maintained in the range of 4.2% to 5.8%. In 2023, the domestic in-hospital sales exceeded 1.2 billion yuan. With the increase in the prevalence of epilepsy and the expansion of indications to the psychiatric field, there is still room for continuous growth in market demand. At present, the domestic preparation market is characterized by the coexistence of original research drugs and generic drugs. 17 enterprises have obtained approval for generic drug preparations, among which 11 have products passed the consistency evaluation. After the implementation of centralized procurement, the price of lamotrigine tablets has dropped by more than 72%, which has further improved the accessibility of the drug and also driven the steady growth of demand for upstream API.

The original research enterprise of lamotrigine is GlaxoSmithKline (GSK), with the original brand name Lamictal. Its core compound patent expired in the United States in 2008, and the core patent in China also expired in 2009. At present, the dosage forms of the original research drug approved in China include tablets (25mg, 50mg, 100mg) and dispersible tablets (5mg, 25mg, 50mg, 100mg). Multiple dosage forms have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and are also listed as FDA reference preparations. On the API level, there are currently more than 30 lamotrigine API registrations on the CDE platform, among which 16 have A-status registration numbers. More than 20 domestic enterprises have obtained approval for lamotrigine-related preparation products, and the domestic supply system is mature. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for lamotrigine API. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process quality control needs in the process of drug research and development, quality research and production.