维格列汀片首仿药即将在国内上市

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2019-08-23 22:09
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(Summary description)维格列汀（Vildagliptin）是诺华研发的一款DPP-4抑制剂，适用于治疗2型糖尿病，于2011年8月正式获得CFDA批准上市。维格列汀单方2018年H1业绩为6.5亿美元，2017年全球业绩为12.33亿美元，2016年为11.93亿美元。在我国，DPP-4抑制剂的市场才起步，西格列汀、沙格列汀、维格列汀、利格列汀和阿格列汀才进入2017年版国家医保目录，而且限制为二线用药，目前也陆续纳入

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维格列汀片首仿药即将在国内上市

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2019-08-23 22:09
Views:

Information

维格列汀（Vildagliptin）是诺华研发的一款DPP-4抑制剂，适用于治疗2型糖尿病，于2011年8月正式获得CFDA批准上市。

维格列汀单方2018年H1业绩为6.5亿美元，2017年全球业绩为12.33亿美元，2016年为11.93亿美元。在我国，DPP-4 抑制剂的市场才起步，西格列汀、沙格列汀、维格列汀、利格列汀和阿格列汀才进入2017年版国家医保目录，而且限制为二线用药，目前也陆续纳入各省市医保目录。

高血糖素样肽1（GLP-1）

胰高血糖素样肽1（GLP-1）是由小肠L细胞分泌的一种肽类激素，食物消化时可促进GLP-1分泌到血管，从而发挥其生理功能。研究显示，GLP-1具有多种生理功能：①诱导前胰岛素基因的转录，促进胰岛素的生物合成和分泌；②促进β细胞增殖分化，抑制β细胞凋亡；③抑制高血糖素的分泌；④延迟胃排空，控制食欲，减少食物摄取。由此可见，GLP-1用于治疗糖尿病有可能控制糖尿病的恶化，并能通过控制食欲降低体重增加的风险，从而弥补现有抗糖尿病药物的一些缺点，具有广阔的应用前景。然而，此肽在体内会很快被二肽基肽酶（DPP-Ⅳ）水解而失活（半衰期仅2 min左右），DPP-Ⅳ抑制剂因而成为当前新型抗糖尿病药物的研究热点。

药物简介

中文名：维格列汀

英文名：Vildagliptin

商品名：佳维乐

分子式：C₁₇H₂₅N₃O₂

南京华讯知识产权顾问有限公司

维格列汀是二肽基肽酶抑制剂的一个代表药物，其与DPP-Ⅳ竞争性结合形成复活物抑制其活性，从而增加血浆中的游离GLP-1浓度，发挥降血糖作用，且在控制血糖的同时逆转糖尿病患者胰岛功能不断恶化的状况，显示了良好的应用前景。

国内专利情形

关于原研公司诺华的专利申请，维格列汀化合物最早在申请日为1999 年12月9日的专利申请CN1160330C中公开，该申请已经授权，保护了维格列汀化合物或其可药用盐以及它们用于抑制DPP-IV、糖尿病、肥胖症的用途，该专利到期日为2019年12月9日。

关于维格列汀的晶型，原研公司的两件专利申请CN101238099A及CN101106977A均没有授权，故目前原研公司没有维格列汀晶型的专利保护。

关于维格列汀制剂专利或专利申请，原研公司的多项专利保护了维格列汀的制剂或组合物，比如CN101208085B保护了含有维格列汀或其药用盐和羟丙基甲基纤维素、微晶纤维素和硬脂酸镁的制剂；CN101618216B保护了一种药用压制片剂或药用直接压片片剂，其含有维格列汀或其药用盐的颗粒；CN101035522B保护了包含维格列汀或其药用盐与格列酮类药物和二甲双胍药物的组合物以及该组合物的用途；CN101277688B保护了包含（1）1.5-20％的维达列汀或其可药用盐和（2）80-98.5％的甲福明或其可药用盐的组合物。

关于维格列汀的用途专利或专利申请，原研公司的最早专利CN1160330C保护了维格列汀用于治疗DPP-IV、糖尿病、肥胖症的应用，之后该公司又申请了维格列汀降低低血糖事件的应用以及用于调节高脂血症的应用，并已经授权，参见专利CN101267838B和CN100402026C。

公开号	专利名称	申请日	法律状态
CN1160330C	N－取代2－氰基吡咯烷类化合物	1999-12-09	授权
CN101238099A	维格列汀的盐	2006-08-02	撤回
CN101106977A	直接压片的配方及方法	2006-01-17	撤回
CN101208085B	1-[(3-羟基-金刚烷基-1-基氨基)-乙酰基]-吡咯烷基-2(s)-腈的调释制剂	2006-06-08	授权
CN101618216B	直接压片配方和方法	2005-01-17	授权
CN101035522B	DPP-Ⅳ抑制剂、PPAR抗糖尿病剂和二甲双胍的组合	2005-10-21	未缴年费
CN101277688B	包含甲福明和维达列汀的配制物	2006-09-25	授权
CN101267838B	DPP-IV抑制剂降低低血糖事件的用途	2006-09-18	授权
CN100402026C	取代的氰基吡咯烷和含有它们的组合制剂用于治疗高脂血症和相关疾病的用途	2003-06-02	未缴年费

本土制药企业布局情况

据统计，南京优科制药、齐鲁制药、泰德制药、豪森药业、四环制药等公司的7 个国产仿制药维格列汀片已经进入生产申请阶段。

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Electronic Arts pledges free use for five accessibility patents

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