The first generic market approved by FDA in 2017

Source: International Drug Administration 2017-08-29 Shenyang Pharmaceutical University International Food and drug policy and Law Research Center foreword "first generics" refers to the generic drugs approved by FDA for the first time Considering the importance of first generic drugs to public health, FDA will generally give priority to the evaluation of first generic drugs In addition, in order to encourage pharmaceutical companies to actively research and develop the first generic drugs, the drug price competition and patent period Recovery Act (also known as "hatch Waxman act") stipulates that the first one to submit anda to FDA, which contains a paragraph IV certification, that is, to prove that there is no patent infringement or patent invalidation certificate If the patent challenge is successful, FDA will grant 180 days of market monopoly period " Knowledge link "the specific regulations of FDA on the market monopoly period of Anda application: (1) only the first applicant who submits a complete anda application and a paragraph IV certification (PIV) will be granted a 180 day market monopoly period; (2) FDA will give a 180 day market monopoly period to the first Anda applicant who is not sued by the patent owner or NDA applicant; (3) If more than one applicant applies for anda on the same day, they can obtain 180 days of market monopoly period; (4) each specification of the drug is given a market monopoly period; (5) prescription drug and medical insurance Promotion Act 2003 Act) stipulates five cases of loss of 180 day exclusive period, including the failure of the first applicant to be listed within the specified time; the first applicant's withdrawal of application, supplementary application or withdrawal of non infringement Certificate (PIV); failure to obtain temporary approval within a specified time; violation of anti trust law Laws); all patents listed in the patent non infringement certificate expire [1] " As of August 2, the FDA approved 46 first generic drugs in 2017 Among them, 17 generic drugs successfully passed the patent challenge and obtained 180 days of market monopoly period Through the challenge of patent and the first listing of generic drugs in the United States, generic pharmaceutical enterprises can not only win huge profits for enterprises, but also provide important support and guarantee for the next step of new drug R & D innovation through the accumulation of technology and capital Therefore, in the current competition pattern of multi-party game in the pharmaceutical market, Chinese pharmaceutical enterprises submit anda applications in the United States, carry out generic patent challenges, strive for a 180 day monopoly period, and obtain the initiative to compete with multinational pharmaceutical giants On August 21, 2017, Huahai pharmaceutical's paroxetine capsule officially obtained the Anda number (207188) This is the first successful generic drug challenged by PIV patent in China This time, paroxetine capsule was approved for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause Paroxetine capsule, developed by noven, was approved by FDA for marketing in the United States in 2013 Currently, only patented products are sold on the market in the United States The product is also not listed in China In 2016, the sales volume of paroxetine capsule in the U.S market was about US $25 million [2] This time, the approval number of paroxetine capsule from FDA indicates that the business of Huahai Pharmaceutical Co., Ltd in the field of first generic drugs and challenging patent products has been steadily promoted, and at the same time, it can effectively enhance the company's core competitiveness References: [1] Dong Li, Yang Yue Research on the provisions of the extension of the patent period and the monopoly period of the U.S drugs [J] China Pharmaceutical Journal, 2006, (05): 391-392 + 384 [1] Huahai Pharmaceutical Co., Ltd announcement of Zhejiang Huahai Pharmaceutical Co., Ltd on the approval number of paroxetine capsule by the U.S FDA [EB / OL] [2017-08-27] Http://med.sina.com/article_detail__.html