Brivaracetam

In response to the demand for long-term control of focal epilepsy, highly selective synaptic vesicle protein 2A (SV2A) ligand antiepileptic drugs have become a hot spot in clinical research and development in recent years. As a second-generation SV2A ligand, brivaracetam regulates neurotransmitter release by specifically binding to the SV2A protein on the presynaptic membrane. Compared with the first-generation drugs, its affinity is increased by 15-30 times, it penetrates the blood-brain barrier faster, and the incidence of central adverse reactions is lower. It is mainly used clinically as monotherapy or add-on therapy for children aged 4 years and above and adult patients with focal epilepsy. It can also significantly reduce the seizure frequency in people with drug-resistant epilepsy, providing a better option for patients who cannot tolerate the adverse reactions of traditional antiepileptic drugs.

The global brivaracetam market size had exceeded 1.9 billion US dollars in 2023, with a compound annual growth rate of 11.2% from 2019 to 2023. The main growth drivers are the increased recognition of it as a first-line recommendation for focal epilepsy in clinical guidelines, and the expansion of the pediatric indication population. The sales of brivaracetam at terminals of public medical institutions in China increased by more than 180% year-on-year in 2023. At present, the original research drug still occupies more than 90% of the market share, and 4 domestic pharmaceutical companies have submitted marketing applications for generic drugs. With the successive approval of generic drugs after patent expiration, it is expected that the domestic market size will exceed 1.5 billion yuan in 2027, and the accessibility will be greatly improved.

The original research enterprise of brivaracetam is UCB, and the original trade name is Vimpat. Its core compound patent expires in 2025 in Europe and the United States, and the compound patent in China expires in March 2026. The main dosage forms approved for the original research drug include tablets, injections and oral solutions. The specifications of tablets are 25mg, 50mg, 75mg and 100mg, the specification of injection is 10ml:50mg, and the specification of oral solution is 100ml:1g. It has been included in the Reference Preparations of the Catalogue of Listed Drugs in China, and is also included in the FDA Reference Preparation Catalogue. Up to now, 7 enterprises have submitted brivaracetam API registration numbers on the API Registration Platform of China CDE, among which 3 are in the status of "A" (already used in marketed preparations), and 6 domestic brivaracetam generic preparations have been approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of brivaracetam impurity reference standards, which can meet the needs of qualitative and quantitative impurity analysis in the whole process from API synthesis to preparation stability research. 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 meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can directly support the consistency evaluation of generic drugs and the submission of application materials.