Generic Drug Entry Prior to Patent Expiration
Author: United States. Federal Trade Commission
Publisher:
Published: 2002
Total Pages:
ISBN-13:
DOWNLOAD EBOOKIn April 2001, the Commission began an industry-wide study focused on certain aspects of generic drug competition under the Hatch-Waxman Amendments. The Amendments provide certain methods by which generic drug manufacturers can obtain approval to market a generic version of a brand-name product. The study's purpose was to provide a more complete picture of how generic drug competition has developed under one method the Amendments established: generic entry prior to expiration of the brand-name company's patents on the relevant drug product.