Levetiracetam

In response to the treatment needs of partial seizures in adult epilepsy patients and pediatric epilepsy patients aged over 4 years, levetiracetam, as a second-generation pyrrolidone antiepileptic drug, has become a common clinical choice with its unique mechanism of action. It specifically binds to the synaptic vesicle protein SV2A to regulate the release of neurotransmitters and inhibit the discharge of abnormal neurons, and does not affect the traditional γ-aminobutyric acid or glutamic acid pathways, with few drug-drug interactions and good tolerability. In addition to monotherapy or adjuvant therapy for partial seizures of epilepsy, it can also be used for the treatment of secondary generalized tonic-clonic seizures, and is one of the preferred options for special epilepsy populations such as the elderly and patients with mild abnormal liver and kidney function.

The share of levetiracetam in the global antiepileptic drug market is stable at around 10%. In 2023, its global market size exceeded 1.8 billion US dollars, and its market size in China exceeded 2.3 billion RMB, with a compound annual growth rate remaining above 6%. After the patent expiration, generic drugs have achieved rapid volume growth. At present, domestic generic drugs account for more than 85% of the market, and oral preparations from nearly 30 enterprises have passed the consistency evaluation. It is a selected variety in the third batch of national centralized drug procurement, and the price of the selected products has dropped by more than 90% compared with the original research drug, which greatly reduces the medication burden of patients.

The original research enterprise of levetiracetam is UCB, with the trade name Keppra. The core compound patent expired in 2008 in the United States and Europe, and expired in 2011 in China. The dosage forms of the original research marketed products include conventional tablets, sustained-release tablets, oral solutions and injections, with specifications covering 0.25g, 0.5g, 0.75g, 100mg/ml, etc. Multiple dosage forms have been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and the FDA Reference Preparation Catalogue. In China, levetiracetam API from more than 60 enterprises have completed registration with the CDE, and the approved and marketed preparations cover all dosage forms such as oral preparations and injections. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of levetiracetam impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for API R&D, quality research and consistency evaluation work.