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On January 26, CSPC submitted a Category 3 generic marketing application for desvenlafaxine succinate sustained-release tablets.
The original research company of this product was Wyeth, which was later acquired by Pfizer and has not yet entered the domestic market
.
In addition to CSPC, Renfu also submitted a listing application in 2019 and was finally approved for clinical use.
Figure 1: The latest products reported by CSPC
Source: CDE official website
Desvenlafaxine, the demethylated active product of venlafaxine, was approved by the FDA in 2008 for the treatment of major depressive disorder, and its global market sales peaked at $737 million in 2014
.
The original research company Wyeth (later acquired by Pfizer) began to declare the import of this product in 2006, and the original research product has not yet been approved for listing in China
Figure 2: Earlier application of domestic generic drugs for desvenlafaxine succinate sustained-release tablets
Source: One-click retrieval from Minet
In 2019, Renfu Pharmaceutical was the first to apply for a Category 3 generic marketing application for desvenlafaxine succinate sustained-release tablets, and it was finally approved for clinical use.
Its confirmatory clinical trial is currently underway; Zhejiang Jianfeng Pharmaceutical reported in August last year.
It is currently under review and approval; CSPC is the third company reporting production, and it is still expected to impact the first imitation
.
In addition, the bioequivalence tests of Yangzijiang Pharmaceutical Group and Jiangsu Hansoh Pharmaceutical have been completed, and they are expected to apply for listing in the future
Figure 3: 2021H1 China's public medical institutions terminal chemical drug antidepressant generic name TOP20 pattern
Source: Minet.
com China's public medical institutions terminal competition pattern
According to the data from Minet.
com, in the first half of 2021, venlafaxine is the TOP2 antidepressant drug in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) terminals, from 2014 to present It has maintained a positive growth trend
.
As an "upgraded" product of venlafaxine, desvenlafaxine succinate sustained-release tablet is expected to achieve good results in the market
Source: CDE official website, Minet database
