First eslicarbazepine epilepsy generic to be approved in China

Generics/News | Posted 10/12/2021 post-comment0 Post your comment

In China, the Yangtze River Pharmaceutical Group submitted the first marketing application of a class 3 generic drug, eslicarbazepine acetate, for use to treat patients with epilepsy, on 15 October 2021.

Epileptic V16F10

The eslicarbazepine acetate originator was first approved in Europe under the name of Zebinix in 2009. It is an epilepsy treatment option that acts to inhibit the repeatedly abnormal discharge of brain neurons and control epilepsy seizures by cutting the conduction of action potential. The originator drug has been shown to be well tolerated after long-term administration and has high efficacy and safety. The originator has not received marketing approval in China but in March 2021 it was included in the market of Second Batch of Suggested Generic Drugs published on the Chinese National Health Commission’s website.

The Yangtze River Pharmaceutical Group’s eslicarbazepine acetate is likely to be the first generic drug approved. However, Sihuan Pharm, Changzhou Pharmaceutical Factory, HUAWE and a number of other pharmaceutical developers are also in the process of creating or having generic versions of eslicarbazepine acetate approved in China.

Eslicarbazepine acetate will not be the first generic epilepsy drug on the market in China. It will join three other antiepileptic drugs, vigabatrin, brivaracetam and fycompa, that are currently on the market in China.

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