Review Article
Regulatory Exclusivities or Non-patent exclusivities
Eleti Shivanvitha*Jawaharlal Nehru Technological University, Hyderabad, Telangana, India
- *Corresponding Author:
- Eleti Shivanvitha
Jawaharlal Nehru Technological University, Hyderabad, Telangana, India
Tel: +91-9059569912
E-mail: shivanvithaeleti@rediffmail.com
Received Date: June 30, 2016; Accepted Date: August 17, 2016; Published Date: August 24, 2016
Citation: Shivanvitha E (2016) Regulatory Exclusivities or Non-patent exclusivities. J Civil Legal Sci 5: 205. doi: 10.4172/2169-0170.1000205
Copyright: © 2016 Shivanvitha E. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Abstract
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.
