[annual inventory] competition of cardiovascular market imitation: 1 first imitation, 8 curative effect and the original research of the same generic drugs will be on the market soon, Hengrui, Huahai, Haizheng, dongyangguang

In 2018, the most accepted cardiovascular system drugs were generic drugs, with 89 acceptance numbers, an increase of 196.67% compared with 30 in 2017 This article will also focus on the analysis of the acceptance of this year's cardiovascular drug imitation: which of the first three varieties to be declared will be listed soon? What are the first imitations of different dosage forms for the new 4 categories of imitations? Which will directly pass the consistency evaluation after listing to occupy the market advantage? Come and have a look In 2018, there was a big outbreak of generic drugs, and the acceptance number increased by 196.67% year on year From Figure 1, we can see the overall acceptance trend of cardiovascular system drugs in the past 10 years In 2013, it reached the peak of application, 966 drugs (calculated according to the acceptance number, the same below) In 2016, it dropped significantly, and slightly picked up in 2017 and 2018 From the perspective of drug application type curve (only to apply for imitation, import, new drugs, import re registration, supplementary application, reexamination and so on), before 2016, cardiovascular system drugs were mostly new drugs and generic drugs; after 2016, new drug applications decreased dramatically, to 2018, only one new drug application, and after 2016, generic drugs declined, they rebounded in 2018, reaching 89 , 196.67% higher than that in 2017 In addition, the number of imported drugs has also dropped significantly this year, from 31 last year to 12 this year It is worth mentioning in Figure 1 that among the 12 acceptance numbers imported, one acceptance number is the bosentan dispersible tablet declared by actalon in chemical medicine category 5.1, which is the first drug approved by FDA for pediatric patients with idiopathic or congenital pulmonary hypertension (PAH) aged 3 and over At present, it has been accepted as a special and excellent variety, and the speed of evaluation is accelerated, and the market is on the way 4 first imitations, Hengrui 1 will take the lead in listing All 89 acceptance numbers of generic drugs are reported for production There are 11 acceptance numbers of generic drugs applied for in the new 3 categories These drugs are drugs that imitate the original research drugs listed abroad but not listed in China, including telmisartan amlodipine tablets, regardson injection, metoprolol tartrate tablets, ibuprofen injection, amlodipine atorvastatin calcium tablets, alisentan and azilsartan tablets Species Up to now, five of them have not been listed in China (see Figure 2 for details) Figure 2 of the 5 varieties, azilsartan tablet and regardson injection have not been imported in China Among them, azilsartan tablet is a hot variety declared by domestic enterprises, with 109 acceptance numbers, 105 of which are declared as new drug category 3.1 and 104 have been approved for clinical application This year's two acceptance numbers are three categories of chemicals declared by Beijing Baiao Pharmaceutical Co., Ltd., and the review has not yet started However, Hengrui pharmaceutical, which also applies for production in chemical medicine category 3, has been accepted in 2017 and has been included in the priority review At present, the review has been started, leading for the time being, and the listing is imminent The other three varieties are all imported in China, but according to the market performance of the imported varieties, telmisartan amlodipine tablets and alisentan have no bid winning information in China, and the imported varieties of amlodipine atorvastatin calcium tablets perform well At present, the drug has a bid winning record in 31 regions, and the number of bid winning regions has a good momentum in recent years This year, amlodipine 5mg: a Torvastatin 10mg * 7 was awarded in 10 regions with an average price of 59.21 yuan This year, there are two acceptance numbers for this variety, all of which are declared by Beijing Jialin Pharmaceutical Co., Ltd., but in addition to one declaration in three categories, there is one declaration in four categories At present, the two acceptance numbers have not been reviewed The production of four different dosage forms is imitated for the first time, and the market prospect is promising A total of 77 acceptance numbers declared in the new four categories, including 26 varieties (except for one acceptance number of four categories declared by Beijing Jialin Pharmaceutical Co., Ltd.), 10 acceptance numbers are the first imitations of different dosage forms of domestic listed varieties, including four varieties of fenofibrate (Ⅲ), metoprolol succinate sustained release tablets, valsartan amlodipine tablets (I) and sakubatrovalsartan sodium tablets, none of which is currently available in China The enterprises have been approved for listing, but all of them have been imported, and two of them have been included in the category B of medical insurance (see Figure 3 for details) Figure 3 4 acceptance numbers of metoprolol succinate sustained-release tablets were all declared by Nantong Lianya Pharmaceutical Co., Ltd according to 4 categories, and 14 of them were declared according to 6 categories in other years, all of which were approved for clinical application The drug was imported from AstraZeneca, and only AstraZeneca won the bid in 32 regions in China 47.5mg * 72018 years ago, it has won the bid in 12 regions, with an average bid price of 15.41 Moreover, the drug has been included in the national B-type medical insurance, with a promising market prospect In addition, one acceptance number of fenofibrate tablets (III) is declared by Kangenbei, and another two acceptance numbers of generic drugs in other years are declared by bercello pharmaceutical and Kangenbei in six categories, and have been approved for clinical application Fenofibrate tablets (III) are only imported from Abbott, and currently have bid winning information in 23 regions The 0.16g * 10 specification won the bid in 4 regions this year, with an average bid price of 38.57 yuan However, this variety has been included in the national health insurance category B in 2017 and is expected to be large-scale in the long term Valsartan amlodipine tablets (I) were the two other imported varieties that won more bids in different regions This year, the two acceptance numbers of this variety are Beijing Baiao pharmaceutical and Jiangsu Hengrui pharmaceutical The latest status is that the review is completed, Hengrui is in the lead, and completed on November 7, 2018 In other years, 35 generic drugs have been declared in 6 categories, including 1 for clinical application, which has been approved; 34 for production; and 15 for clinical application Valsartan amlodipine tablets (I) are only imported from Novartis, and have won bids in 24 regions The number of winning regions is on the rise In 2018, valsartan 80mg: Amlodipine 5mg * 7 won bids in 10 regions, with an average bid price of 52.08 yuan Eight generic drugs with the same therapeutic effect as the original research will be put on the market soon Of the remaining 67 generic drug acceptance numbers of pivastatin calcium tablets, nifedipine sustained-release tablets or Chengyi, 22 varieties are included, and one or more enterprises are approved for production in China The listing applications of 8 varieties with relevant acceptance numbers are included in the priority review and approval (details are shown in Figure 4) There are two reasons for inclusion: 1 Voluntarily withdrawing and re applying for generic registration after being improved according to the standards consistent with the quality and efficacy of the original research drug; 2 The same production line has been listed in the United States, and such varieties are deemed to pass the consistency evaluation after being listed Figure 4 included in the first case include 3 varieties (Figure 5 marked red varieties): atorvastatin calcium tablets declared by Beijing Wansheng Pharmaceutical Co., Ltd., with 2 acceptance numbers in total; risuvastatin calcium tablets declared by Hefei Yingtai Pharmaceutical Co., Ltd., with 1 acceptance number in total; pivastatin calcium tablets declared by Nanjing Changao pharmaceutical Co., Ltd., with 1 acceptance number in total Among them, atorvastatin calcium tablet has been evaluated by two enterprises, Zhejiang xindonggang Pharmaceutical Co., Ltd and Beijing Jialin Pharmaceutical Co., Ltd., and Beijing Wansheng Pharmaceutical Co., Ltd may become the third evaluated enterprise after its successful listing There have been 4 enterprises that have reviewed risuvastatin calcium tablets, and Changzhou pharmaceutical factory has also issued one The review is imminent, so even if Hefei Yingtai is listed, it will face strong competition However, pivastatin calcium tablet has not yet been evaluated by enterprises China Resources Shuanghe Pharmaceutical Co., Ltd and Jiangsu Wanbang biochemical pharmaceutical group are also carrying out be test and have not started to declare If Nanjing Changao Pharmaceutical Co., Ltd is successfully listed, it is likely to become the first listed enterprise Included in the second case are 5 varieties (not marked with red in Figure 5): olmesartan ester hydrochlorothiazide tablets and Telmisartan Tablets declared by Huahai Pharmaceutical Co., Ltd., 3 acceptance numbers respectively; irbesartan hydrochlorothiazide tablets declared by Haizheng Pfizer Co., Ltd., 2 acceptance numbers in total; nifedipine sustained release tablets declared by Nantong Lianya pharmaceutical Co., Ltd., 3 acceptance numbers in total; amlodipine besylate tablets declared by Guangdong dongyangguang Pharmaceutical Co., Ltd , 1 acceptance number in total In addition, there are 4 acceptance numbers of rosuvastatin calcium tablets declared by Changzhou pharmaceutical factory included in this case At present, it shows that they have been delivered The over evaluation of this product has been mentioned above, and will not be described here At present, no enterprise has passed the consistency evaluation of olmesartan ester hydrochlorothiazide tablets and Telmisartan Tablets Only one enterprise of olmesartan ester hydrochlorothiazide tablets has been approved for production, but the consistency evaluation has not been started yet Although there are 39 domestic production enterprises of Telmisartan Tablets, only Shanghai Xinyi Tianping Pharmaceutical Co., Ltd and Zhejiang Jinliyuan Pharmaceutical Co., Ltd are carrying out be test, and the progress is slow Huahai Pharmaceutical Co., Ltd is most likely to become the first evaluated enterprise of 2 varieties The consistency evaluation of irbesartan hydrochlorothiazide tablets has been passed by two enterprises, Huahai pharmaceutical and Zhengda Tianqing, and Zhejiang Ainuo pharmaceutical has only started be Therefore, Haizheng Pfizer may become the third evaluated enterprise, forming a three foot stand No enterprise of nifedipine sustained-release tablets has passed the consistency evaluation, and no domestic approved enterprise has carried out the consistency evaluation record Nantong Lianya Pharmaceutical Co., Ltd has great hope to become the first evaluated enterprise Amlodipine besylate tablets, Yangzijiang Pharmaceutical Group, Zhejiang Jingxin pharmaceutical and other five enterprises have been evaluated, and a number of enterprises have also been accepted, so whether Guangdong dongyangguang pharmaceutical has become the sixth evaluated enterprise is still very uncertain, with fierce competition In addition to the varieties included in the priority review, of the other 23 acceptance No 14 varieties, only one enterprise of alisentan tablet passed the consistency evaluation, and none of the other enterprises passed the evaluation, with a large play space, it depends on who is faster and who has passed the listing first Details are as follows: data source: Pharmaceutical intelligence data statement: this point of view only represents the author, not the position of pharmaceutical intelligence network, 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.