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A cheat sheet to navigate the complex maze of pharmaceutical exclusivities in Europe

机译:一个备忘单,用于导航欧洲的药物专区复杂迷宫

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As the two leading markets for pharmaceutical and biotech companies, the USA and Europe offer incentives to stimulate drug innovation, including patent and regulatory exclusivities. These exclusivities extend periods during which companies can market their products free of generic or other competition and recoup their investment. Pharmaceutical and biotech companies should carefully assess the different types of exclusivities available when developing regulatory submissions, patent filing strategies. The authors have previously summarized the USA exclusivities in an earlier publication. This article focuses on European exclusivities. Due to space limitations, it focuses on small molecule drugs. Analogously to the format previously used, we have provided a cheat sheet of European exclusivities for small molecule drugs in Figure 1.
机译:作为制药和生物技术公司的两个主要市场,美国和欧洲提供刺激毒药创新的激励,包括专利和监管专区。 这些独家延长期间,公司可以在哪些公司销售其产品,没有通用或其他竞争并收回其投资。 制药和生物技术公司应仔细评估制定监管提交,专利申请策略时提供的不同类型的独家。 此前,该作者在早期的出版物中始终总结了美国的独家。 本文重点介绍欧洲独家。 由于空间限制,它专注于小分子药物。 类似于以前使用的格式,我们为图1中的小分子药物提供了欧洲独家的作弊表。

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