Summary of 105 drugs passing conformity assessment

It is far from the last two months of 2018, and the progress of "289 catalog" variety consistency evaluation is far from the required goal to be completed by the end of 2018 According to the statistics of cypress blue, up to now, there are 105 products that have passed or deemed to have passed the consistency evaluation (see the end of the article for the detailed list) 6 Review of drug consistency evaluation in the past 10 months, 6 drugs passed the consistency evaluation, the details are as follows: 1 Metformin hydrochloride tablets On October 2, Sihuan pharmaceutical announced that the group's diabetes drug metformin hydrochloride tablets (0.25g) had been approved by the State Drug Administration to pass the quality and efficacy consistency evaluation of generic drugs, becoming the first enterprise in China to apply and pass the supplementary application according to the consistency evaluation Market scale: according to the over 3 billion yuan meter intranet database, in 2017, the sales volume of metformin tablets in public hospitals across the country was 3.081 billion yuan, with a market growth rate of 18.7%, ranking the second in the market scale of oral hypoglycemic drugs in China (data source: minenet database) more and more people use metformin at the grassroots level Judging from the use of metformin in hospitals at all levels, the market share of metformin in grassroots medical institutions is growing It can be seen that under the policy of hierarchical diagnosis and treatment, as a chronic disease of diabetes patients, it has obviously sunk to the grass-roots level (data source: minenet database) 2 On the evening of October 12, Hengrui pharmaceutical announced that it had received the supplementary application approval document for irbesartan tablets (0.15g) approved and issued by the State Food and drug administration, which passed the consistency evaluation of quality and efficacy of generic drugs At the same time, Hengrui is the second enterprise that has passed the consistency evaluation Irbesartan is a long-acting antagonist of angiotension Ⅱ receptor, which can be used to treat primary hypertension and type 2 diabetic nephropathy with hypertension Market scale: more than 3 billion yuan According to the Internet database, in 2017, the sales volume of irbesartan tablets in the national public hospitals was 3.242 billion yuan, and the market growth slowed down gradually (data source: minenet database) the market of generic drugs in China is obviously divided From the market pattern data of irbesartan tablets, we can see that Sanofi, as the original research drug, only accounts for less than half of the market Local pharmaceutical enterprises such as Jiangsu Hengrui, China Resources Shuanghe and Shijiazhuang Yiling have a very obvious market division (data source: minenet database) 3 On October 11, Beijing new pharmaceutical industry announced that its sertraline hydrochloride tablets (50mg) passed the consistency evaluation of generic drugs and became the only enterprise among the varieties that passed the consistency evaluation Sertraline is an antidepressant, which was developed by Pfizer in 1991 It is mainly used to treat adult severe depression Market growth rate: up to 23% According to the minenet database, in 2017, the sales volume of sertraline hydrochloride tablets in national public hospitals was 914 million yuan, with a market growth rate of 23.84% It can be seen that in recent years, sertraline hydrochloride tablets are very worthy of attention in terms of market demand and growth potential (data source: minenet database) domestic generic drugs have launched an impact In terms of market pattern, Pfizer, the original research enterprise, still accounts for more than 60% of the market of sertraline hydrochloride tablets However, as the first Beijing new pharmaceutical industry to pass the consistency evaluation, it can not be underestimated At present, the enterprise has occupied nearly 18% of the market share At the same time, Zhejiang Huahai, Tianjin Huajin and other enterprises are also striving to catch up (data source: minenet database) 4 In the evening of October 11, amoxicillin capsule was announced by Kangenbei Jinhua Kangenbei, the holding subsidiary of amoxicillin capsule, received the approval document for supplementary drug application issued by the State Food and Drug Administration on amoxicillin capsule (0.25g) The drug passed the consistency evaluation of generic drugs Market scale: the growth rate slowed down significantly According to the intranet database, the market growth rate of amoxicillin capsule dropped from more than 20% in 2014 to 2016, to 1.99% in 2017, and the growth rate slowed down significantly In 2017, the market size was 978 million yuan Market competition: the competition of amoxicillin is very fierce Prior to conerby, UL's Amoxicillin capsule also passed the consistency evaluation It is understood that at present, there are 10 enterprises with 12 acceptance numbers applying for conformity evaluation of this variety From the perspective of market pattern, amoxicillin Capsule Market has no absolute advantage (data source: minenet database) 5 On October 15, the three specifications (5mg, 10mg, 20mg) of escitalopram oxalate tablets of Shandong Jingwei Pharmaceutical Co., Ltd passed the generic consistency evaluation at the same time, which also made escitalopram oxalate tablets (10mg) become another generic consistency evaluation product with three enterprises Market scale: 1.5 billion yuan according to the minenet database, in 2017, the sales volume of escitalopram oxalate tablets in national public hospitals was 1.5 billion yuan, with a market growth rate of 20.14% In recent years, escitalopram oxalate tablets can maintain a rapid growth trend, which shows that the future market of this product is still very worthy of expectation (data source: minenet database) strong market segmentation of generic drugs of China From the perspective of market pattern, Sichuan Kelun and Shandong Jingwei, the imitators of escitalopram tablet, have exceeded 50% of the market share in total, and both of them have passed the consistency evaluation It is believed that the following market competition will bring greater impact on Lingbei, the original research enterprise (data source: minenet database) 6 On October 16, rosuvastatin calcium tablet, the official website of Xiansheng pharmaceutical company announced that its subsidiary, Nanjing Xiansheng Dongyuan Pharmaceutical Co., Ltd., had received the supplementary application approval document from the State Drug Administration, and "shufutan ® - rosuvastatin calcium tablet" had passed the consistency evaluation of generic drugs Market scale: more than 5 billion yuan According to the minenet database, the market scale of rosuvastatin calcium tablets in the national public hospitals reached 5.019 billion yuan in 2017, with a market growth rate of 22.86%, and in recent years, it has maintained a rapid growth (data source: minenet database) market pattern: fierce competition With Nanjing Xiansheng Dongyuan Pharmaceutical Co., Ltd passing the generic consistency evaluation, rosuvastatin calcium tablet (10mg) became the first product that passed the consistency evaluation and reached four enterprises Before that, Zhengda Tianqing, Zhejiang Haizheng and Zhejiang Jingxin all passed the consistency evaluation From the perspective of market pattern, as the above enterprises pass the consistency evaluation, the competition between local enterprises and original research enterprise AstraZeneca will become more intense (data source: minenet database) up to now, there have been three consistency evaluations of the six varieties, and six of the 105 varieties that have passed the consistency evaluation of generic drugs or are deemed to have passed the consistency evaluation of generic drugs have passed the enterprise's three or more varieties They are: rosuvastatin calcium tablet (10mg), amlodipine besylate tablet (5mg), tenofovir dipivoxil fumarate tablet (0.3g), montmorillonite powder (3G), cefuroxime ester tablet (0.25g) and escitalopram oxalate tablet (10mg) Four of them have passed the consistency evaluation According to the policy requirements, if there are more than three manufacturers that have passed the consistency evaluation for the same kind of drugs, the products that have failed the consistency evaluation will not be used in the centralized purchase of drugs At present, more and more provinces put forward restrictions on drugs without conformity evaluation Drugs that have not been evaluated for consistency will become more and more difficult The current pharmaceutical market will also face a reshuffle Appendix: summary of varieties passing the consistency evaluation (as of October 31)