Rufinamide

In response to the treatment dilemma of refractory epilepsy, especially Lennox-Gastaut syndrome (LGS), a severe epileptic encephalopathy with onset in childhood, existing drugs are often difficult to achieve comprehensive seizure control. Rufinamide, a third-generation triazole antiepileptic drug, exerts its effect by prolonging the inactivated state of voltage-gated sodium channels and inhibiting abnormal high-frequency discharge of neurons. It is currently an adjuvant treatment for LGS recommended by guidelines, which can significantly reduce the frequency of drop attacks and tonic-clonic seizures. Its applicable population covers LGS patients aged 4 years and above, including children and adults, providing a new treatment option for patients with poor response to traditional drugs.

The global market size of rufinamide was approximately USD 920 million in 2023. Driven by the rising prevalence of epilepsy, the improved diagnosis rate of LGS and the expansion of pediatric indications, it is expected to grow steadily at a compound annual growth rate of 4.2% from 2024 to 2030. In terms of the competitive landscape, the original research product has long occupied more than 75% of the global market share. With the expiration of core patents, pharmaceutical companies in India and China have successively launched generic drug R&D. At present, 3 enterprises in China have submitted marketing applications for generic drugs, and the accessibility of the drug is expected to be further improved after the implementation of centralized procurement in the future.

The original research enterprise of rufinamide is Novartis, with the trade name Banzel/Inovelon. Its compound patent for the US market expired in 2024, and the validity period of the core compound patent in China is until 2025. The main dosage form approved by the original research is tablet, with specifications of 0.2g and 0.4g, which have been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs (Third Batch)*. In terms of domestic API registration, there are currently 5 API registration numbers, of which 2 are in the status of "A" (have passed the associated review with preparations), and 1 domestic enterprise's rufinamide generic preparation was approved for marketing in 2023. (Data as of May 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for rufinamide API, covering a total of 12 kinds of impurities including synthesis process impurities and degradation impurities. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA, and the impurity structures have been confirmed by triple structure verification of NMR, MS and HPLC, which can support the full-process needs of enterprises from API synthesis, quality research to preparation declaration.