创新仿制药生命周期管理策略之研究—以马来酸左旋氨氯地平片为例摘要.docVIP

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 Study on the innovation of generic life cycle management strategy —With levoamlodipine maleate tablets as an example Background: Innovation of generics is improved based on the original research drug drugs on the development and innovation of generics, relative to the development of the original drug research, investment and risk is relatively low, is a shortcut to the enterprise independent innovation has the technology advantage. However, innovation of generics in branded and generic drugs, so how to make life cycle management in the cracks? This point is the biggest challenge facing the innovation of generic drugs. Objective: To study the life cycle management strategy on innovation of generic drugs. Research methods: the research method of this paper were analyzed and summed up the data. Research contents: This paper based on the innovation of generics levoamlodipine maleate tablets ( trade name: Xuan Ning ) and original research drug of amlodipine besylate tablets ( trade name: Norvasc ) were compared in the technology innovation and patent protection, difference of promotion and so on, and summarizes the life cycle management strategy innovation generics. Results: there were shortcomings and defects of levoamlodipine maleate tablets in the technology innovation and patent protection, promotion and other aspects of the differences, need to improve their life cycle management strategy. Conclusion: life cycle management strategy innovation of generic technology innovation, patent protection, promotion of the diff