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Analyzing the Generic Drugs Sector of the US Pharmaceutical Industry

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Published Date: Feb, 2011
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No of Pages: 80
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  • Abstract
  • Table of Contents
A generic drug is a copy that is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use.

Generic drugs are less expensive because generic manufacturers don't have the investment costs of the developer of a new drug. New drugs are developed under patent protection. The patent protects the investment - including research, development, marketing, and promotion - by giving the company the sole right to sell the drug while it is in effect. As patents near expiration, manufacturers can apply to the FDA to sell generic versions. Because those manufacturers don't have the same development costs, they can sell their product at substantial discounts. Also, once generic drugs are approved, there is greater competition, which keeps the price down. Today, almost half of all prescriptions are filled with generic drugs.

Generic manufacturers do not incur the cost of drug discovery, and instead are able to reverse-engineer known drug compounds to allow them to manufacture bioequivalent versions. Generic manufacturers also do not bear the burden of proving the safety and efficacy of the drugs through clinical trials, since these trials have already been conducted by the brand name company. In most countries, generic manufacturers must only prove that their preparation is bioequivalent to the existing drug in order to gain regulatory approval. It has been estimated that the average cost to brand-name drug companies of discovering and testing a new innovative drug (with a new chemical entity) may be as much as $800 million.

Generic drug companies may also receive the benefit of the previous marketing efforts of the brand-name drug company, including media advertising, presentations by drug representatives, and distribution of free samples. Many of the drugs introduced by generic manufacturers have already been on the market for a decade or more, and may already be well-known to patients and providers (although often under their branded name).

Aruvian's R'search presents Analyzing the Generic Drugs Sector of the US Pharmaceutical Industry – a comprehensive coverage of the generic drugs market in the United States. The report presents high-quality data in written and graphical format for researchers and readers alike. Beginning with a sectional description on generic drugs, the report covers topics such as the impact of the generics sector on major pharma companies, R&D strategies being implemented by major pharma companies in the generics sector, the long debate over generic drugs versus branded drugs, and much more – a cost analysis of branded drugs versus generic drugs being a highlight.

An overview of the global generics sector builds up the scene for the analysis of the US generics industry. The all-important Hatch-Waxman Framework, the DEFRA Regulation, and other recent regulatory measures are included in this analysis from Aruvian, along with the emerging issue of promoting generic drug competition in the US Market.

Being a major section of the report, Promoting Generic Drug Competition in the US Market covers topics such as issues with the FDA Approval Process, the role of the Orange Book, the positive and negative outcomes of the Hatch Waxman Act, the manipulation of this act, promoting methods for generic drug availability, amongst other points of discussion.

Strategies for survival employed by branded manufacturers, the role of generic drugs in lowering US drug re-importation, a case study on generic antidepressants, the approval of the generic version of GSK’s drug Coreg, the introduction of Bill S.438, and the substantial move by Blue Cross in major changes to its drug plans, are discussed and analyzed in this report.

Analysis of major industry players such as Teva Pharmaceutical Industry, Mylan Laboratories, Barr Pharmaceuticals, Watson Pharmaceuticals, Impax Laboratories, and Zentiva, concludes this comprehensive research report from Aruvian's R'search.

Table of Contents:

A. Executive Summary

B. What are Generic Drugs?
B.1 Introduction to Generic Drugs
B.2 Economics of Generics
B.3 Approval Process for US Generic Drug
B.4 Generics versus Brand Name Drugs
B.5 Generic Drug (ANDA) Review Process: A Graphical Representation
B.6 Impact of the Generics Sector on Major Pharmaceutical Companies: A Graphical Representation B.7 Strategies for Top Pharma Companies Competing against the Generics Sector: A Graphical Representation
B.8 Research & Development Strategies Engaged by Majors in the Generics Sector: A Graphical Representation
B.9 Cost Containment & Role of Generics
B.10 Impact of Generics on Treatment Costs versus Cost Effectiveness
B.11 How to Protect the Branded Product?
B.12 Major Patent Expirations: 2007-2009

C. Overview of the Global Generics Sector
C.1 Sector Definition
C.2 Rise of the Generic Industry
C.3 Industry Profile
C.4 Market Segmentation
C.5 Competition in the Global Generics Sector
C.6 Looking at Formulation Impact
C.7 Outlook for the Generics Sector

D. Overview of the Generics Sector in the United States
D.1 Sector Definition
D.2 Industry Profile
D.3 Market Segmentation
D.4 Competition in the US Generics Sector
D.5 How Small Companies are Benefiting from Big Pharma’s Branded Medicines?
D.6 Impact of Generic Competition in the US on the Overall Return to Investment
D.7 Outlook for the US Generics Sector

E. Analyzing the Entry of Authorized Generics in the US Pharmaceutical Industry
E.1 Introduction
E.2 The Hatch-Waxman Framework
E.3 Entry of Authorized Generics
E.4 Regulatory Decisions Affecting Authorized Generics
E.5 Recent Regulatory Measures
E.6 Authorized Generics & Litigations
E.7 The Medicaid Drug Rebate Statute
E.8 Enactment of DEFRA
E.9 Conclusion

F. Promoting Generic Drug Competition in the US Market
F.1 Introduction
F.2 Problems with the FDA Approval Process
F.3 Role of the Hatch-Waxman Act
F.4 Role of the Orange Book
F.5 Analysis of Incentives Provided for the Generic Drug Applicant
F.6 Outcome of the Hatch-Waxman Act
F.6.1 Positive Consequences
F.6.2 Negative Consequences
F.6.3 Manipulating the Hatch-Waxman Act: Inadvertent Consequences
F.7 A Look at the Point of View of Big Pharma
F.8 How to Promote Generic Drug Availability & Solving Overall Industry Crisis
F.8.1 Overview
F.8.2 Lowering the Cost of Prescription Drugs
F.8.3 Introduction of The McCain-Schumer Bill
F.8.3.1 30-Month Stay
F.8.3.2 180-day Exclusivity
F.8.3.3 Generic Manipulations
F.8.3.4 Requirement of “Full & Complete” Patent Listing
F.8.3.5 Declaratory Judgment
F.8.3.6 Rolling Exclusivity
F.9 Removing Conflicts from the FDA Approval Process
F.9.1 Overall Process
F.9.2 Conclusion

G. Strategies for Branded Manufacturers
G.1 Introduction
G.2 Developing a New Approach to Patent Litigations
G.3 Employing Line Extensions

H. Generic Drugs’ Role in US Drug Re-importation

I. Case Study: Generic Antidepressants

J. Case Study: Approval of Generic Version of GlaxoSmithKline’s Coreg

K. Case Study: Introduction of Bill S.438

L. Case Study: Major Change to Drug Plan by Blue Cross

M. Leading Industry Players
M.1 Teva Pharmaceutical Industries
M.2 Mylan Laboratories Inc.
M.3 Watson Pharmaceuticals
M.4 Barr Pharmaceuticals, Inc.
M.5 Impax Laboratories, Inc.
M.6 Zentiva

N. Appendix

O. Glossary of Terms

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