If a generic drug product application is submitted for approval before the expiration of any patents or exclusivities granted to the original, brand-name product, FDA issues a tentative approval letter to the applicant. The tentative approval letter delays final approval of the generic drug product until all patent or exclusivity issues have been resolved. A product that has tentative approval cannot be marketed or sold in the United States.
The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.