Журнал гражданских и юридических наук

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Regulatory Exclusivities or Non-patent exclusivities

Eleti Shivanvitha

Pharmaceutical development is an expensive, time consuming and uncertain process that takes years to complete. Often, patent protection expires before a new drug is approved for marketing. As a result, most pharmaceutical companies in the United States and European Union (EU) depend on the exclusivity rights granted under the U.S. Federal Food, Drug and Cosmetic Act (FDCA), and the corresponding EU authorities to recoup their considerable investment in the drug development and approval process. Therefore, pharmaceutical companies must understand and employ the different forms of nonpatent exclusivity in both the U.S. and EU in order to succeed in the global marketplace.