1991-2010年26个撤市药品分析

Analysis of the 26 Kinds of Withdrawal Drug during 1991-2010

目的:分析撤市药品,为制药企业保证产品在市场的稳定性提供参考。方法:对由艾美仕市场研究公司及美国FDA1991-2010年公布的26个撤市药品进行治疗类别,药品研发过程中的合作、并购、专利情况,不同时间撤市药品的数量,退市时间与替代药品注册时间的分析。结果与结论:治疗类别对撤市药品的影响并不明显,专利与合作经营已经不再能保证产品在市场的稳定性。严格的药品安全监管体制、副作用小且疗效较好的替代药品是影响药品撤市的主要原因。

OBJECTIVE：To analyze withdrawal drugs,and to provide reference for the stability guarantee of product in the market by pharmaceutical manufacturers.METHODS：26 kinds of withdrawal drugs announced in 1991-2010 by IMS Health Inc.and USA FDA were analyzed from therapeutic classification,cooperation,MA and patent situation during the RD process,number of different time,withdrawal time and marketed time of substitutes.RESULTS CONCLUSIONS：Drugs withdrawal is hardly affected by therapeutic areas,and patent and co-operation can no longer guarantee the stability of market.Main reasons for drugs withdrawal are strict supervision system,substitutes with low side effect and high efficiency.