Lacosamide

As a representative product of the third-generation antiepileptic drugs, lacosamide selectively promotes the slow inactivation of voltage-gated sodium channels, reduces the pathological discharge of neurons, and does not affect the conduction of normal physiological electrical signals. It is one of the antiepileptic drugs with outstanding tolerance performance in current clinical practice. This drug can be used for monotherapy and add-on therapy of partial-onset seizures in epilepsy patients aged 4 years and above, and can also be used as adjunctive therapy for primary generalized tonic-clonic seizures in patients aged 16 years and above, providing a new treatment option for patients who are intolerant to traditional antiepileptic drugs or have poor response.In recent years, the global market size of antiepileptic drugs has continued to expand. With its excellent clinical benefits, lacosamide's global market sales exceeded 3 billion US dollars in 2023, among which the growth rate in the Chinese market was as high as 35%, making it one of the fastest-growing varieties in the current antiepileptic field. The domestic layout of generic drugs is concentrated. At present, lacosamide preparations from more than 20 enterprises have been approved for marketing. In the inter-provincial centralized procurement in many regions, the price reduction of preparations has exceeded 80%, and the stable supply of upstream active pharmaceutical ingredients has become a core element for relevant enterprises to maintain market competitiveness.The original developer of lacosamide is UCB, and the original brand name is "Vimpat". The expiration date of its core compound patent in China is 2026. The dosage forms approved for the original product include tablets, injections and oral solutions. The specifications of the tablets cover 50mg, 100mg, 150mg and 200mg. The original product has been included in the China Listed Drugs Catalogue as the reference listed drug. Up to now, there are more than 30 registration records of lacosamide active pharmaceutical ingredients on the API registration platform of China CDE, among which nearly 20 are in status A, which can be associated with the marketing application of corresponding preparations. A number of domestic enterprises have obtained approval for the marketing of lacosamide oral preparations and injections. (Data as of November 2024, please refer to the official CDE website for the latest information)CATO provides a full set of lacosamide impurity reference standards. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the use needs of different stages such as API research and development, quality research, and declaration and registration.

近年来全球抗癫痫药物市场规模持续扩容，拉考沙胺凭借优异的临床获益，2023年全球市场销售额已突破30亿美元，其中中国市场增速高达35%，是当前抗癫痫领域增长最快的品种之一。国内仿制药布局集中，目前已有超过20家企业的拉考沙胺制剂获批上市，多地省际集采中制剂价格降幅超过80%，上游原料药的稳定供应已成为相关企业维持市场竞争力的核心要素。

拉考沙胺原研企业为优时比（UCB），原研商品名为“维派特”，其核心化合物专利在中国的到期时间为2026年。原研获批的剂型包括片剂、注射剂及口服溶液，片剂规格涵盖50mg、100mg、150mg、200mg，原研产品已被列入中国上市药品目录集作为参比制剂。截至当前，中国CDE原料药登记平台已有超过30条拉考沙胺原料药登记记录，其中近20条状态为A，可关联对应制剂上市申报，国内已有多家企业的拉考沙胺口服制剂、注射剂获批上市。（数据截至2024年11月，最新请以CDE官网为准）

CATO/佳途科技提供拉考沙胺全套杂质标准品，大部分产品现货供应，现货产品16:00前下单当天发货，所有产品符合中国药典、FDA等多法规合规要求，可充分满足原料药研发、质量研究、申报注册等不同阶段的使用需求。