Regulatory Exclusivities or Non-patent exclusivities

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.

The Process of development of a pharmaceutical is time taking, costly and uncertain. The long-time duration of the process may result in expiry of the patent term before the marketing of the product. To overcome this difficulty the United States and European Union (EU) have advised the concept of exclusivities which help in recovering the investment that was made in the process? The product can be marketed during the period of exclusivity without any competition from its generic form.