Author : United States. Federal Trade Commission
Release : 2002-01-01
Genre : Law
Kind : eBook
Book Rating : 456/5 ( reviews)
Book Synopsis Generic Drug Entry Prior to Patent Expiration by : United States. Federal Trade Commission
Download or read book Generic Drug Entry Prior to Patent Expiration written by United States. Federal Trade Commission. This book was released on 2002-01-01. Available in PDF, EPUB and Kindle. Book excerpt: "In 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. This report sets forth the results of the study. The study was prompted, in part, by the Commission's enforcement actions against alleged anticompetitive agreements that relied on certain Hatch-Waxman provisions. The study was designed to determine whether such agreements are isolated instances or more typical, and whether particular provisions of the Hatch-Waxman Amendments are susceptible to strategies to delay or deter consumer access to low-cost generic alternatives to brand-name drug products." -- from the Introduction, p. 1.
