How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry

How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry PDF Author:
Publisher: U.S. Government Printing Office
ISBN:
Category : Business & Economics
Languages : en
Pages : 94

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Book Description

How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry

How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry PDF Author:
Publisher: U.S. Government Printing Office
ISBN:
Category : Business & Economics
Languages : en
Pages : 94

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Book Description


Generic drug entry prior to patent expiration an FTC study

Generic drug entry prior to patent expiration an FTC study PDF Author:
Publisher: DIANE Publishing
ISBN: 1428951938
Category :
Languages : en
Pages : 129

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Book Description


Drug Wars

Drug Wars PDF 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.

The Waxman Report

The Waxman Report PDF Author: Henry Waxman
Publisher: Twelve
ISBN: 0446545678
Category : Political Science
Languages : en
Pages : 151

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Book Description
At a time when some of the most sweeping national initiatives in decades are being debated, Congressman Henry Waxman offers a fascinating inside account of how Congress really works by describing the subtleties and complexities of the legislative process. For four decades, Waxman has taken visionary and principled positions on crucial issues and been a driving force for change. Because of legislation he helped champion, our air is cleaner, our food is safer, and our medical care better. Thanks to his work as a top watchdog in Congress, crucial steps have been taken to curb abuses on Wall Street, to halt wasteful spending in Iraq, and to ban steroids from Major League Baseball. Few legislators can match his accomplishments or his insights on how good work gets done in Washington. In this book, Waxman affords readers a rare glimpse into how this is achieved-the strategy, the maneuvering, the behind-the-scenes deals. He shows how the things we take for granted (clear information about tobacco's harmfulness, accurate nutritional labeling, important drugs that have saved countless lives) started out humbly-derided by big business interests as impossible or even destructive. Sometimes, the most dramatic breakthroughs occur through small twists of fate or the most narrow voting margin. Waxman's stories are surprising because they illustrate that while government's progress may seem glacial, much is happening, and small battles waged over years can yield great results. At a moment when so much has been written about what's wrong with Congress-the grid, the partisanship, the influence of interest groups-Henry Waxman offers sophisticated, concrete examples of how government can (and should) work.

Drug Price Competition and Patent Term Restoration Act of 1984

Drug Price Competition and Patent Term Restoration Act of 1984 PDF Author: United States. Congress. Senate. Committee on Labor and Human Resources
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 382

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Book Description


Generic Animal Drug and Patent Term Restoration Act

Generic Animal Drug and Patent Term Restoration Act PDF Author: United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts, Civil Liberties, and the Administration of Justice
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 204

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Book Description


Rare Diseases and Orphan Products

Rare Diseases and Orphan Products PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442

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Book Description
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Generic Drug Product Development

Generic Drug Product Development PDF Author: Isadore Kanfer
Publisher: CRC Press
ISBN: 1420020021
Category : Medical
Languages : en
Pages : 334

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Book Description
Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutica

The ParagraphFour Book

The ParagraphFour Book PDF Author: Gregory Glass
Publisher:
ISBN: 9781734372106
Category :
Languages : en
Pages :

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Book Description
The ParagraphFour Book describes how generic drug products make it to a drug store's shelf. In most cases, these products travel through the Paragraph IV Market --- a place where they challenge the validity of the brand drug's patents in a United States District Court. The book covers the Hatch-Waxman Act and the intersection of the patent law, regulations, and competition that create the Paragraph IV Market. Written as an easy-to-read business book, it is not a legal treatise and would appeal to attorneys, pharmaceutical professionals, and interested consumers.

ANDA Litigation

ANDA Litigation PDF 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.