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Medical Network, February 23, February 21, Yangtze River Pharmaceutical Group Sichuan Hairong Pharmaceutical applied for the acceptance of the application for the imitation of Brivaracetam injection for the 3 types of imitation listing.
At present, there is no brivaracetam-related preparation in the domestic market.
Batch
.
The original research company of brivaracetam (also known as brivaracetam) is U-Times.
In 2016, it was approved by the European Union EMA and the US FDA to be listed as an additional treatment for other drugs for the treatment of partial seizures in patients with epilepsy aged 16 years and over
.
Figure 1: The registration status of brivaracetam injection declared by Yangtze River Source: CDE official website Figure 2: Global sales of briracetam (also known as brivaracetam) (unit: million euros) Source: Meine.
com multinational listing The company's sales database Levetiracetam used to be the best-selling anti-epileptic drug.
Brivaracetam (also known as Buvaracetam) has a similar structure to Levetiracetam.
The binding force of SV2A is 10 times stronger.
Drugs with higher bioavailability, shorter peak time and better market prospects
.
According to data from Mi Nei.
com, after the original research product was approved for listing in 2016, the global sales growth rate in 2017 reached 383.
33%.
In 2018, sales exceeded 100 million euros and rose to 220 million euros in 2019
.
Table 1: Current domestic market application status of brivaracetam related preparations Source: Meinenet MED2.
0 Chinese drug review database Ushibi's Brivaracetam tablets import 5.
1 clinical application has been approved, domestic pharmaceutical company Zhong Jiangxi Qingfeng The pharmaceutical industry has declared that the application for the generic listing of Buwaxitan tablets in category 3 has been approved for clinical use, while currently only Yangzijiang has applied for the listing of generic drugs in category 3 and is under review and approval
.
Since 2021, Yangzijiang has filed 18 new product listing applications, of which 5 are neurological drugs.
In addition to brivaracetam injection, vothiaxetine hydrobromide tablets and eslicarbazepine acetate tablets are also expected Impact the first imitation
.
Source: Meinnet database, CDE official website.
The review data statistics are as of February 22, 2021.
If there are any errors or omissions, please correct me
.
At present, there is no brivaracetam-related preparation in the domestic market.
Batch
.
The original research company of brivaracetam (also known as brivaracetam) is U-Times.
In 2016, it was approved by the European Union EMA and the US FDA to be listed as an additional treatment for other drugs for the treatment of partial seizures in patients with epilepsy aged 16 years and over
.
Figure 1: The registration status of brivaracetam injection declared by Yangtze River Source: CDE official website Figure 2: Global sales of briracetam (also known as brivaracetam) (unit: million euros) Source: Meine.
com multinational listing The company's sales database Levetiracetam used to be the best-selling anti-epileptic drug.
Brivaracetam (also known as Buvaracetam) has a similar structure to Levetiracetam.
The binding force of SV2A is 10 times stronger.
Drugs with higher bioavailability, shorter peak time and better market prospects
.
According to data from Mi Nei.
com, after the original research product was approved for listing in 2016, the global sales growth rate in 2017 reached 383.
33%.
In 2018, sales exceeded 100 million euros and rose to 220 million euros in 2019
.
Table 1: Current domestic market application status of brivaracetam related preparations Source: Meinenet MED2.
0 Chinese drug review database Ushibi's Brivaracetam tablets import 5.
1 clinical application has been approved, domestic pharmaceutical company Zhong Jiangxi Qingfeng The pharmaceutical industry has declared that the application for the generic listing of Buwaxitan tablets in category 3 has been approved for clinical use, while currently only Yangzijiang has applied for the listing of generic drugs in category 3 and is under review and approval
.
Since 2021, Yangzijiang has filed 18 new product listing applications, of which 5 are neurological drugs.
In addition to brivaracetam injection, vothiaxetine hydrobromide tablets and eslicarbazepine acetate tablets are also expected Impact the first imitation
.
Source: Meinnet database, CDE official website.
The review data statistics are as of February 22, 2021.
If there are any errors or omissions, please correct me
.