创新仿制药生命周期管理策略之研究—以马来酸左旋氨氯

I摘要研究背景：创新仿制药是指在原研药的基础上做的改进型药品，开发创新仿制药相对于开发原研药而言，投入以及风险相对较低，是企业自主创新取得技术优势的一条捷径。然而，创新仿制药处在原研药与仿制药之间，那么如何在夹缝中做好生命周期管理？这一点无疑是创新仿制药所面临的最大挑战。研究目的：本论文拟就创新仿制药的生命周期管理策略进行研究。研究方法：本论文研究方法为对数据进行对比分析与归纳整理。研究内容：本论文通过对创新仿制药马来酸左旋氨氯地平片（商品名：玄宁）与原研药苯磺酸氨氯地平片（商品名：络活喜）在技术创新与专利保护、差异推广等方面进行对比分析，并归纳整理出创新仿制药的生命周期管理策略。研究结果：马来酸左旋氨氯地平片在技术创新与专利保护、差异推广等方面均存在不足与缺陷，因此需对其生命周管理策略进行完善。研究结论：创新仿制药的生命周管理策略包括技术创新、专利保护，差异推广，此三者相辅相成，缺一不可，能够实现产品的生命周期管理。关键词：创新仿制药；生命周期管理；策略；马来酸左旋氨氯地平片Studyontheinnovationofgenericlifecyclemanagementstrategy—WithlevoamlodipinemaleatetabletsasanexampleBackground:Innovationofgenericsisimprovedbasedontheoriginalresearchdrugdrugsonthedevelopmentandinnovationofgenerics,relativetothedevelopmentoftheoriginaldrugresearch,investmentandriskisrelativelylow,isashortcuttotheenterpriseindependentinnovationhasthetechnologyadvantage.However,innovationofgenericsinbrandedandgenericdrugs,sohowtomakelifecyclemanagementinthecracks?Thispointisthebiggestchallengefacingtheinnovationofgenericdrugs.Objective:Tostudythelifecyclemanagementstrategyoninnovationofgenericdrugs.Researchmethods:theresearchmethodofthispaperwereanalyzedandsummedupthedata.Researchcontents:Thispaperbasedontheinnovationofgenericslevoamlodipinemaleatetablets(tradename:XuanNing)andoriginalresearchdrugofamlodipinebesylatetablets(tradename:Norvasc)werecomparedinthetechnologyinnovationandpatentprotection,differenceofpromotionandsoon,andsummarizesthelifecyclemanagementstrategyinnovationgenerics.Results:therewereshortcomingsanddefectsoflevoamlodipinemaleatetabletsinthetechnologyinnovationandpatentprotection,promotionandotheraspectsofthedifferences,needtoimprovetheirlifecyclemanagementstrategy.Conclusion:lifecyclemanagementstrategyinnovationofgenerictechnologyinnovation,patentprotection,promotionofthedifferences,thethreecomplementeachother,areindispensable,canrealizethelifecyclemanagementofproducts.Keywords:innovationgenerics，lifecyclemanagement，strategy，levoamlodipinemaleatetablets目录前言.........................................................................................................................................1第1章技术创新与专利保护...........................................................................................31.1原研药...................................................................................................................................41.2创新仿制药...........................................................................................................................71.2.1苯磺酸左旋氨氯地平片...................................................................................................71.2.2马来酸左旋氨氯地平片...................................................................................................81.3本章总结...............................................................................................................................9第2章差异推广...............................................................................................................92.1竞争对手...............................................................................................................................92.2苯磺酸氨氯地平片.............................................................................................................112.2.1第一阶段..........................................................................................................................112.2.2第二阶段..........................................................................................................................122.2.3第三阶段..........................................................................................................................132.3苯磺酸左旋氨氯地平片.....................................................................................................132.3.1第一阶段..........................................................................................................................132.3.2第二阶段..........................................................................................................................142.3.3第三阶段..........................................................................................................................152.4马来酸左旋氨氯地平片.....................................................................................................182.5本章总结.............................................................................................................................19第3章马来酸左旋氨氯地平片的生命周期管理.........................................................193.1马来酸左旋氨氯地平片的技术创新与专利保护.............................................................223.1.1专利情况与注册情况......................................................................................................223.1.2数据分析..........................................................................................................................233.1.3小结..................................................................................................................................253.2马来酸左旋氨氯地平片的差异推广.................................................................