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On September 24, Nanjing Zhengda Tianqing 4 class of generic drug "Mirabelon slow release tablets" submitted a listing application and was accepted by CDE, for the second domestic newspaper listing.
, there is no similar varieties of generic drugs approved in China.
Mirabelon is the first approved beta-3-subject excitant for bladder hyperactive disorder (OAB) to selectively relax the bladder by acting on beta epinephrine (beta-ARs) to force urine muscles and promote urine storage, thereby increasing bladder capacity and prolonging urination intervals without affecting bladder emptying.
the drug was first developed by Astellas and first listed in Japan in 2011, followed by the United States, the United Kingdom, Europe and Canada, and was approved by NMPA in September 2017 for domestic listing under the name Bettanli ®.
public data show global sales of $1.35 billion in 2018 and terminal sales of 140,000 yuan for public medical institutions in China in the same year after listing in China at the end of May 2018.
the Insight database, Mirabelon has only been approved for the domestic market, and no generic drugs have been approved.
With the exception of Nanjing Zhengda Tianqing, only one company submitted for listing was listed in October 2019 and was approved for priority review in April 2020, one year before the patent expired.
addition, there are five companies undergoing BE trials, namely Ruiyang Pharmaceuticals, Jiangsu Huayang Pharmaceuticals, Shenzhen Wanle Pharmaceuticals, Shanxiang Pharmaceuticals, Sichuan Guowei Pharmaceuticals.
from: Insight Database ()