3.1 the first batch of imitations of levetiracetam are coming out

According to the information on May 14 on the website of the State Food and Drug Administration (CFDA), zuoxiracetam APIs and tablets, a class 3.1 chemical drug, which are applied for production by xinlitai, Jingxin pharmaceutical and Chongqing shenghuaxi pharmaceutical, have become "under examination and approval", and there are only regular signing processes such as certificate preparation and approval If there is no accident, the three pharmaceutical companies are expected to obtain production approval next month, realizing the first batch of domestic imitation Levetiracetam is mainly used for the treatment of local and secondary systemic epilepsy The original research drug is Belgium United Chemical Enterprise (UCB S.A.) At present, a variety of preparations (tablets, injection, oral solution) of levetiracetam have been listed in the United States and the European Union for many years, among which tablet and oral solution formulations have been listed in China in 2011 According to the clinical terminal statistics of Nanfang Institute, from 2008 to 2012, the global sales of levetiracetam ranked second in the list of antiepileptic drugs, with a compound annual growth rate of 56% In 2012, the sales volume of the product in domestic sample hospitals reached 78.77 million yuan, a substantial increase of 67% year on year At present, the domestic market of the product is completely monopolized by UCB, and the market is mainly concentrated in Beijing, Chengdu, Shanghai, Guangzhou and other major cities The data shows that epilepsy is the second most common disease in neurology after cerebrovascular disease The lifetime prevalence rate of epilepsy in China is 7 ‰, about 41% of the patients do not receive appropriate treatment; the prevalence rate of active epilepsy is 4.6 ‰, about 63% of the patients do not receive any antiepileptic treatment, and the treatment gap is large Xinlitai has said that the domestic anti epileptic drug market shows a significant growth momentum, and the company believes that the product has good market potential.