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The World Market for Prescription Generic Drugs, 5th Edition

The landscape of generic companies is changing: their relative might in the industry is increasing and the product lines their offering are growing in depth and breadth. Strong growth in the sector has come not only from more aggressive tactics and better acceptance in the clinical and consumer population, but by the loss of patent protection in the past few years of some huge-name drugs, including Prozac, Zocor, Prilosec, Prevacid, Sporanox, Evista, Flovent, Claritin, Allegra, Diflucan, Zofran, Zoloft, and Pravachol.

This comprehensive study quantifies world markets 2000 to 2010 in the following therapeutic categories: examined at the level of manufacturers’ revenues in each of the following product categories:

  • allergy and respiratory drugs,
  • analgesics (including NSAIDs) and anti-rheumatic drugs,
  • anesthesia,
  • anti-infectives,
  • cancer drugs,
  • cardiovascular drugs,
  • CNS drugs,
  • gastrointestinal drugs,
  • hormone drugs, and
  • ophthalmic drugs.

In addition to market size and growth, market share of leading competitors, the report discusses regulatory, clinical, and business trends and issues in detail, including

  • how the Hatch-Waxman Act works and fails to work,
  • how FDA funding plans will affect filings and approvals in the coming years,
  • what strategies big pharma is using to fend off market share erosion, like autorized generics and aggressive patent filing,
  • how generic biologics fit in the picture,
  • how M&A activity is changing the landscape, and
  • many more

The report also details the big-name drugs set to lose protection over the next 6 years and what level of revenue is at stake for whom.

The report also includes profiles of the top players, including:

  • Actavis Group
  • Altana Pharma AG
  • Andrx Corporation
  • Apotex Group
  • Aurobindo Pharma, Ltd.
  • Barr Laboratories, Inc.
  • Bedford Laboratories
  • Lannett Company, Inc.
  • Mylan Laboratories, Inc.
  • Orchid Chemicals and Pharmaceuticals, Ltd.
  • Par Pharmaceuticals, Inc.
  • Perrigo Company
  • PLIVA Pharmaceuticals, Inc.
  • Ranbaxy Laboratories, Ltd.
  • Roxane Laboratories, Inc.
  • Sandoz International, GmbH
  • Taro Pharmaceutical Industries Ltd.
  • TEVA Pharmaceutical Industries, Ltd.
  • Watson Pharmaceuticals, Inc.
  • United Research Laboratories and Mutual Pharmaceutical Company
  • Zydus Pharmaceuticals, Inc.


  • Executive Summary
    • INTRODUCTION
    • SCOPE AND METHODOLOGY
    • SIZE AND GROWTH OF THE MARKET
      • Table Market Suumary: World Market for Prescription Generic Drugs Revenues by Segment 2000-2010
    • TRENDS AFFECTING THE MARKET
    • MARKET OUTLOOK
  • Introduction
    • INDUSTRY DEVELOPMENT
      • Generic Drug Industry Evolution
      • FDA Regulation
      • Development and Approval Process
    • INDUSTRY STRUCTURE
      • Table Brand Name Companies with Generic Subsidiaries
    • PRODUCT DISTRIBUTION
    • PATENT EXPIRATIONS
      • Table Number of Best Selling Drugs with Patents Expiring in Years 2006-2012 Grouped by Treatment Category
      • Table Best Selling Prescription Drugs with Expected Patent Expirations (Year of Expiration, Brand, Manufacturer, Indication, 2004 Revenues) 2006-2012
  • Allergy and Respiratory Drugs
    • PRODUCT CATEGORIES
      • Asthma, Bronchodilators and Corticosteroids
      • Antihistamines, Decongestants, and Cough Preparations
    • PRODUCT NEWS
      • Table Prescription Allergy and Respiratory ANDA Approvals, 2005
    • MARKET SIZE AND FORECAST
      • The World Market
        • Table The World Market for Prescription Generic Allergy and Respiratory Drugs by Type 2000-2010
        • Table The World Market for Prescription Generic Allergy and Respiratory Drugs, Market Share by Type 2000-2010
      • The U.S. vs World Market
        • Table The World Market for Prescription Generic Allergy and Respiratory Drugs, U.S. Revenues and Share 2000-2010
    • COMPETITIVE ANALYSIS
      • Table The World Market for Prescription Generic Allergy and Respiratory Drugs, Revenues and Market Share by Supplier 2005
  • Analgesics, Nonsteroidal AntiInflammatory Drugs, and Antirheumatic Drugs
    • PRODUCT CATEGORIES
      • Analgesics
      • Nonsteroidal Anti-inflammatory Drugs
      • Antirheumatics
    • PRODUCT NEWS
      • Table Prescription Generic Analgesic, NSAID, and Antirheumatic ANDA Approvals, 2005
    • MARKET SIZE AND FORECAST
      • The World Market
        • Table The World Market for Prescription Generic Analgesics, NSAIDs and Antirheumatic Drugs by Type 2000-2010
        • Table The World Market for Prescription Generic Analgesics, NSAIDs, and Antirheumatic Drugs, Market Share by Type 2000-2010
      • The U.S. vs World Market
        • Table The World Market for Prescription Generic Analgesics, NSAIDs, and Antirheumatic Drugs, U.S. Revenues and Share 2000-2010
    • COMPETITIVE ANALYSIS
      • Table The World Market for Prescription Generic Analgesics, NSAIDs, and Antirheumatic Drugs Revenues and Market Share by Supplier 2005
  • Anesthesia Drugs
    • PRODUCT CATEGORIES
      • General
      • Local
      • Regional
    • PRODUCT NEWS
      • Table Prescription Generic Anesthesia Drug ANDA Approvals, 2005
    • MARKET SIZE AND FORECAST
      • The World Market
        • Table The World Market for Prescription Generic Anesthesia Drugs 2000-2010
      • The U.S. vs World Market
        • Table The World Market for Prescription Generic Anesthesia Drugs, U.S. Revenues and Share 2000-2010
    • COMPETITIVE ANALYSIS
      • Table The World Market for Prescription Generic Anesthesia Drugs, Revenues and Market Share by Supplier 2005
  • Anti-Infectives
    • PRODUCT CATEGORIES
      • Systemic Anti-Infectives
      • Topical Anti-Infectives
    • PRODUCT NEWS
      • Table Prescription Generic Anti-infective Drug ANDA Approvals, 2005
    • MARKET SIZE AND FORECAST
      • The World Market
        • Table The World Market for Prescription Generic Anti-Infective Drugs by Type 2000-2010
        • Table The World Market for Prescription Generic Anti-Infective Drugs, Market Share by Type 2000-2010
      • The U.S. vs World Market
        • Table The World Market for Prescription Generic Anti-Infective Drugs U.S. Revenues and Share 2000-2010
    • COMPETITIVE ANALYSIS
      • Table The World Market for Prescription Generic Anti-Infective Drugs, Revenues and Market Share by Supplier 2005
  • Cancer Drugs
    • PRODUCTS
    • PRODUCT NEWS
      • Table Prescription Generic Cancer Drug ANDA Approvals 2005
    • MARKET SIZE AND FORECAST
      • The World Market
        • Table The World Market for Prescription Generic Cancer Drugs 2000-2010
      • The U.S. vs World Market
        • Table The World Market for Prescription Generic Cancer Drugs, U.S. Revenues and Share 2000-2010
    • COMPETITIVE ANALYSIS
      • Table The World Market for Prescription Generic Cancer Drugs, Revenues and Market Share by Supplier 2005
  • Cardiovascular Drugs
    • PRODUCT CATEGORIES
      • Positive Inotropic Agents
      • Antiadrenergics
      • Beta-Adrenergic Blocking Agents
      • Vasodilators
      • Calcium Channel Blockers
      • Angiotensin-Converting Enzyme Inhibitors
      • Antiarrhythmics
      • Antihyperlipidemic Agents
      • Anticoagulants
      • Diuretics
    • PRODUCT NEWS
      • Table Prescription Generic Cardiovascular Drug ANDA Approvals. 2005
    • MARKET SIZE AND FORECAST
      • The World Market
        • Table The World Market for Prescription Generic Cardiovascular Drugs by Type 2000-2010
        • Table The World Market for Prescription Generic Cardiovascular Drugs, Market Share by Type 2000-2010
      • The U.S. vs. World Market
        • Table The World Market for Prescription Generic Cardiovascular Drugs U.S. Revenues and Share 2000-2010
    • COMPETITIVE ANALYSIS
      • Table The World Market for Prescription Generic Cardiovascular Drugs, Revenues and Market Share by Supplier 2005
  • Central Nervous System and Psychotherapeutic Drugs
    • PRODUCT CATEGORIES
      • Antidepressants, Stimulants, and Antipsychotics
      • Anticonvulsants, Antispasmodics, and Muscle Relaxants
      • Parkinson's Disease, Myasthenia Gravis, and Multiple Sclerosis
      • Sedatives, Hypnotics, and Antianxiety Drugs
    • PRODUCT NEWS
      • Table Prescription Generic Central Nervous System/Psychotherapeutic Drug ANDA Approvals 2005
    • MARKET SIZE AND FORECAST
      • The World Market
        • Table The World Market for Prescription Generic Central Nervous System Drugs by Type 2000-2010
        • Table The World Market for Prescription Generic Central Nervous System Drugs, Market Share by Type 2000-2010
      • The U.S. vs World Market
        • Table The World Market for Prescription Generic Central Nervous System Drugs, U.S. Revenues and Share 2000-2010
    • COMPETITIVE ANALYSIS
      • Table The World Market for Prescription Generic Central Nervous System Drugs, Revenues and Market Share by Supplier 2005
  • Gastrointestinal Drugs
    • PRODUCT CATEGORIES
      • Antidiarrheals
      • Antinauseants
      • Antispasmodics
      • Antiulcer
      • Digestants
    • PRODUCT NEWS
      • Table Prescription Generic Gastrointestinal Drug ANDA Approvals 2005
    • MARKET SIZE AND FORECAST
      • The World Market
        • Table The World Market for Prescription Generic Gastrointestinal Drugs by Type, 2000-2010
        • Table The World Market for Prescription Generic Gastrointestinal Drugs, Market Share by Type 2000-2010
      • The U.S. vs the World Market
        • Table The World Market for Prescription Generic Gastrointestinal Drugs, U.S. Revenues and Share 2000-2010
    • COMPETITIVE ANALYSIS
      • Table The World Market for Prescription Generic Gastrointestinal Drugs, Revenues and Market Share by Supplier 2005
  • Hormonal Drugs
    • PRODUCT CATEGORIES
      • Male and Female Hormones
      • Corticosteroids
      • Diabetes Drugs
      • Thyroid Drugs
    • PRODUCT NEWS
      • Table Prescription Generic Hormone Drug ANDA Approvals 2005
    • MARKET SIZE AND FORECAST
      • The World Market
        • Table The World Market for Prescription Generic Hormone Drugs by Type 2000-2010
        • Table The World Market for Prescription Generic Hormone Drugs, Market Share by Type 2000-2010
      • U.S. vs World Market
        • Table The World Market for Prescription Generic Hormone Drugs U.S. Revenues and Share 2000-2010
    • COMPETITIVE ANALYSIS
      • Table The World Market for Prescription Generic Hormone Drugs, Revenues and Market Share by Supplier 2005
  • Ophthalmic Drugs
    • PRODUCT CATEGORIES
      • Ophthalmic Anti-Infectives
      • Ophthalmic Anti-Inflammatories and Mast Cell Inhibitors
      • Glaucoma Agents
    • PRODUCT NEWS
      • Table Prescription Generic Ophthalmic Drug ANDA Approvals 2001
    • MARKET SIZE AND FORECAST
      • The World Market
        • Table The World Market for Prescription Generic Ophthalmic Drugs by Type 2000-2010
        • Table The World Market for Prescription Generic Ophthalmic Drugs, Market Share by Type 2000-2010
      • U.S. vs World Market
        • Table The World Market for Prescription Generic Ophthalmic Drugs, U.S. Revenues and Share 2000-2010
    • COMPETITIVE ANALYSIS
      • Table The World Market for Prescription Generic Ophthalmic Drugs, Revenues and Market Share by Supplier 2005
  • World Market Summary
    • OVERVIEW
    • TOTAL MARKET SIZE AND FORECAST
      • Table The World Market for Prescription Generic Drugs Revenues by Segment 2000-2010
    • MARKET AND COMPETITIVE ANALYSIS
      • Table World Market for Prescription Generic Drugs Revenues and Segments of Participation by Leading Player 2005
  • Issues and Trends
    • UNDERSTANDING HATCH-WAXMAN AND ITS SHORTFALLS
    • THE FDA, FUNDING AND REVIEW TIMES
    • BIG PHARMA TACTICS-DEFENSIVE AND OFFENSIVE
    • AUTHORIZED GENERICS
    • GENERIC BIOLOGICS
    • MEDICAID GENERIC DRUG REIMBURSEMENT ISSUES
    • THE ELDERLY
    • CONFUSION IN GENERIC DRUG NAMES
    • BROADENING GENERIC HORIZONS
    • INTERNATIONAL GENERIC DRUG ISSUES
      • Table Reorganization of Major Japanese Generic Drug Manufacturers
    • INDUSTRY CONSOLIDATION
    • NEW GENERIC GIANTS
    • PATENT ISSUES: FILINGS AND CHALLENGES
    • PATENT REFORM
    • GENERIC GROWTH: PRESCRIPTIONS, APPROVALS, IMPACT
    • GENERIC STATINS COUNTDOWN
    • PRESCRIPTION DRUG COSTS
    • GENERICS IMPROVE COMPLIANCE
    • GENERIC DRUG SAMPLING
  • Company Profiles
    • INDUSTRY STRUCTURE AND PARTICIPANTS
    • ACTAVIS GROUP
    • ALTANA PHARMA AG
    • ANDRX CORPORATION
    • APOTEX GROUP
    • AUROBINDO PHARMA, LTD
    • BARR LABORATORIES, INC.
    • BEDFORD LABORATORIES
    • LANNETT COMPANY, INC.
    • MYLAN LABORATORIES, INC.
    • ORCHID CHEMICALS AND PHARMACEUTICALS, LTD.
    • PAR PHARMACEUTICALS, INC.
    • PERRIGO COMPANY
    • PLIVA PHARMACEUTICALS, INC.
    • RANBAXY LABORATORIES, LTD.
    • ROXANE LABORATORIES, INC.
    • SANDOZ INTERNATIONAL, GMBH
    • TARO PHARMACEUTICAL INDUSTRIES LTD.
    • TEVA PHARMACEUTICAL INDUSTRIES, LTD.
    • WATSON PHARMACEUTICALS, INC.
    • UNITED RESEARCH LABORATORIES AND MUTUAL PHARMACEUTICAL COMPANY
    • ZYDUS PHARMACEUTICALS, INC
  • Company Directory

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