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Author: United States. Federal Trade Commission
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 136
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Book Description
Author: United States. Federal Trade Commission
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 136
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Book Description
Author:
Publisher: DIANE Publishing
ISBN: 1428951938
Category :
Languages : en
Pages : 129
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Book Description
Author: United States. Federal Trade Commission
Publisher: William s Hein & Company
ISBN: 9781575887456
Category : Law
Languages : en
Pages : 113
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Book Description
"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.
Author: United States. Federal Trade Commission
Publisher:
ISBN:
Category : Patent medicines
Languages : en
Pages : 0
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Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher:
ISBN:
Category : Competition
Languages : en
Pages : 150
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Book Description
Author: Kenneth L. Dorsney
Publisher: American Bar Association
ISBN: 9781614384786
Category : Biotechnology
Languages : en
Pages : 0
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Book Description
Examining the intersection between the statutory and regulatory scheme governing approval of generic pharmaceuticals and U.S. patent law in the context of Paragraph IV ANDA litigation, this comprehensive guide focuses on current and developing law as well as litigation strategies and tactics. This ready roadmap begins with an explanation of the Hatch-Waxman Act, its implementation, and litigation. Other topics include preparing and trying the case, post-trial issues and appeals, remedies, settlement, antitrust implications, and litigation of pharmaceuticals outside the U.S.
Author: United States. Federal Trade Commission
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages :
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Book Description
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.
Author: Robin Feldman
Publisher: Cambridge University Press
ISBN: 131673949X
Category : Law
Languages : en
Pages : 165
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Book Description
While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher:
ISBN: 9780756742195
Category : Competition
Languages : en
Pages : 142
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Book Description
Hearing on whether innovator drug companies may be using questionable tactics to delay the entry of generic competitors. Witnesses: Mark A. Barondess; Lester M. Crawford, Acting Commr., & Daniel D. Troy, Chief Counsel, Food & Drug Admin. (FDA); Gregory J. Glover, Ropes & Tray, on behalf of PhRMA; Kathleen D. Jaeger, Pres. & CEO, Generic Pharmaceutical Assoc.; Sharon Levine, Assoc. Exec. Dir., the Permanente Medical Group, on behalf of RxHealthValue; & Timothy J. Muris, Chmn., Fed. Trade Comm. (FTC).
Author:
Publisher: U.S. Government Printing Office
ISBN:
Category : Business & Economics
Languages : en
Pages : 94
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Book Description
