Manfu pharmaceutical hydrochloric acid pyrethride slow release tablets have been approved by the U.S. FDA

On November 26, People's Fu Pharmaceuticals announced that recently, its controlling subsidiary Yichang People's Fu Pharmaceutical Co., Ltd. (hereinafter referred to as "Yichang People's Fu", the company holds 80% of its shares) received the APPROVAL number of the U.S. FDA on the release of hydrochloric acid pyrethone tablets, drug specifications of 1mg, 2mg, 3mg, 4mg.
hydrochloric acid pyrethroid tablets are used in the treatment of attention deficit ADHD and are suitable for children and adolescents aged 6-17 who are unfit, insatiable or shown to be ineffective with stimulants.
Yichang People's Fu submitted an APPLICATION for ANDA in 2019 for the slow release of hydrochloric acid pyrethloric tablets, with a cumulative research and development investment of approximately US$1.5 million.
Takeda Pharmaceuticals U.S.A., Inc., holds two patents for the hydrochloric acid pyrethloric tablets, which are due on June 20, 2021 and January 4, 2023, respectively, and so far no party believes that Yichang People's Fu's hydrochloric acid pyrethloric tablets infringe the above patent rights.
, according to IQVIA data, the total sales of hydrochloric acid pyrethloride tablets in the U.S. market in 2019 were approximately $45 million, with major manufacturers including APOTEX, TEVA, TWI, etc.
According to Minenet statistics, hydrochloric acid pyridone slow release tablets have not been approved for sale in China, there are currently Nanjing Haina Pharmaceutical Technology Co., Ltd., Zhengzhou Daming Pharmaceutical Technology Co., Ltd., Henan Zhong Shuai Pharmaceutical Technology Development Co., Ltd., Jinan Baino Pharmaceutical Technology Development Co., Ltd. and other companies to the State Drug Administration declaration.
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