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    Home > Medical News > Latest Medical News > [heavyweight] tadalafil's first listing

    [heavyweight] tadalafil's first listing

    • Last Update: 2019-02-19
    • Source: Internet
    • Author: User
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    According to the domestic drug information of the State Food and drug administration, Changchun Haiyue tadalafei tablet was first imitated and listed on the market with the approval number of gjzz h20193041 Tadalafil was developed by Eli Lilly It was first approved by the European Drug Administration (EMA) on November 12, 2002, approved by the US Food and Drug Administration (FDA) on November 21, 2003, and approved by the Japanese pharmaceutical medical device integration Agency (PMDA) on July 31, 2007 Sold by Lilly in the UK and Germany under the name Cialis Tadalafil is a phosphodiesterase 5 (PDE-5) inhibitor It is used to treat erectile dysfunction (ED) and benign prostatic hyperplasia (BPH) Compared with the main PDE5 inhibitors, tadalafil's sales and growth are very considerable Although its sales are not as good as sildenafil's in 2011-2015, it has occupied an advantage in the last two years, surpassing sildenafil's, with sales of USD 3.932 billion in 2017 According to the SWOT analysis of tadalafil provided by Thomson Reuters report, compared with the main competitor sildenafil, the main advantage of tadalafil is that its effect lasts longer than the latter (36hvs12h), and unlike sildenafil, the absorption of tadalafil is not affected by food SWOT analysis also indicated that tadalafil should be taken 60-120 minutes before sex, compared with 30-60 minutes before sex and 15 minutes before sex In addition, the incidence of myalgia side effects caused by tadalafil was higher than that of sildenafil, which constituted another disadvantage of tadalafil compared with sildenafil Global sales of major PDE5 inhibitor drugs source: article of "exclusive" of "tacanafil Asian male trial obtains positive results" In terms of domestic applications for tadalafil, 90 acceptance numbers are generic applications, all of which are reported for production Among them, Changchun Haiyue pharmaceutical's API and tablet acceptance numbers were included in the 24th batch of priority review in November 2017 on the basis of "drug production application one year before the expiration of patent" Qilu Pharmaceutical (Hainan) tablet application was included in the 30th batch of priority review in July 2018 on the basis of "the same production line has passed the FDA production site inspection" In addition, dongyangguang, Zhengda Tianqing, humanwell pharmaceutical, Chengdu Shengdi, etc have applied for the new registration in categories 3 and 4 At present, Changchun Haiyue has been approved and listed for the first time, which will open up the competition pattern with the original research institute Data source: registration and acceptance database of pharmaceutical smart drugs at present, domestic tadalafil import application specifications are mainly 20mg, 10mg, 2.5mg, 5mg, among which the most winning regions are 20mg, Lilly pharmaceutical wins the bid in 26 regions, with the average winning price of 106.5 yuan, and the regional thermal map is shown below: data source: Pharmaceutical smart drug winning information query database Part of the content information reference: and State Drug Administration statement: this view only represents the author, not the position of welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.
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