中文摘要：

目的 通过对美国授权仿制药战略原理、特点以及影响进行研究,为中国学者探讨授权仿制药战略以及中国制药企业在美国市场面临授权仿制药竞争时提供借鉴。方法 通过案例分析和政策解析,总结品牌药厂商在美国市场中使用授权仿制药策略的特点。结论与结果 成功的授权仿制药战略能够使品牌药厂商的产品在专利到期后仍能后维持较大的市场份额。中国制药企业需要根据自身的情况在美国市场选择不同的授权仿制药策略。

英文摘要：

ObjectiveTo study the principle, feature and impact of the authorized generics strategy in American drug market, thus to provide some references for Chinese scholars who research the authorized generics strategy and for China pharmaceutical companies that would face competition in American pharmaceutical market. Methods By case study and policies analysis, the ways how the brand-name companies used the authorized generics in American drug market were summarized. Results AND Conclusion Successful authorized generics strategy can maintain a large market share of the brand-name companies products. In American drug market, there are some particularities about the authorize generics strategy due to the features of American drug policies and regulations. China pharmaceutical companies should implement different authorized generics strategy according to their own conditions in American drug market at present.