我国医药企业对专利悬崖期的药品仿制策略初探  

Preliminary study on strategy of generics during patent cliff in China

作　　者：申团结[1] 黄泰康[1,2] 

机构地区：[1]沈阳药科大学现代社会药学研究中心,沈阳110016 [2]国家食品药品监督管理局,北京100810

出　　处：《中国新药杂志》2014年第2期134-136,153,共4页Chinese Journal of New Drugs

摘　　要：专利悬崖期的到来为我国医药企业带来了巨大的商机,与此同时,我国医药企业也将面临更多关于仿制技术、市场占有竞争、市场话语权以及多项或者后续专利的潜在风险等方面的挑战。本文结合国内企业实际情况及市场状况,对如何应对专利悬崖期的问题与策略进行了探讨,提出了系统制定仿制计划,抢占时间制高点的建议,从研发、生产以及营销环节的整合和协调着手,提供了我国医药企业在针对专利悬崖期的药品仿制各个环节的应对策略。The forthcoming of patent cliff has brought big business opportunities to Chinese pharmaceutical enterprises.Meanwhile,Chinese pharmaceutical enterprises are facing more challenges on generic technology,competition of market share,market discourse power and potential risk of multi-patent or post-patent.In this paper,combining with reality of domestic pharmaceutical enterprises and market condition,we discussed some strategies for the issue of the patent cliff.Furthermore,we proposed particular suggestions on establishing systematical generic drug plan and seizing the commanding heights of time.There is a need for greater coordination among departments of R＆D,production and marketing,therefore some strategies are provided to well organize the elements of every process involved in generic drugs during patent cliff.

关 键 词：专利悬崖期 机遇 挑战 仿制药策略 

分 类 号：R972.6[医药卫生—药品]