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Generic Drugs: Needs and Issues
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Editors: Ryan S. Blanton
Book Description:
The practice of “authorized generics” has recently been the subject of considerable attention by the pharmaceutical industry, regulators, and members of Congress alike. An “authorized generic” (sometimes termed a “branded,” “flanking,” or “pseudo” generic) is a pharmaceutical that is marketed by or on behalf of a brand name drug company, but is sold under a generic name. Although the availability of an additional competitor in the generic drug market would appear to be favorable to consumers, authorized generics have nonetheless proven controversial. Some observers believe that authorized generics potentially discourage independent generic firms both from challenging drug patents and from selling their own products. This book presents an analysis of the innovation and public health issues relating to authorized generic drugs. The book begins with a review of the procedures through which independent generic drug companies receive government permission to market their products and resolve patent disputes with brand-name firms. It also provides detailed background information pertaining to the concept of authorized generics and assesses their potential impact upon patent challenges and consumer welfare, as well as a summary of congressional issues and possible alternatives.

Table of Contents:

1. Authorized Generic Pharmaceuticals: Effects on Innovation
(John R. Thomas) pp. 1-25

2. Paying Off Generics to Prevent Competition with Brand Name Drugs: Should It Be Prohibited? Hearing before the Committee on the Judiciary, United States Senate, January 17, 2007
(U.S. Government Printing Office) pp. 27-74

3. Safe and Affordable Biotech Drugs: The Need for A Generic Pathway, Hearing before the Committee on Oversight and Government Reform, House of Representatives, March 26, 2007
(U.S. Government Printing Office) pp. 75-146

      Health Care Issues, Costs and Access
   Binding: Hardcover
   Pub. Date: 2009 - 3rd Quarter
   Pages: 157 pp.
   ISBN: 978-1-60692-843-1
   Status: AV
Status Code Description
AN Announcing
FM Formatting
PP Page Proofs
FP Final Production
EP Editorial Production
PR At Prepress
AP At Press
AV Available
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Generic Drugs: Needs and Issues