Description
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.
Table of Contents
Chapter One: Executive Summary
- Introduction
- Scope and Methodology
- Size and Growth of the Market
- Trends Affecting the Market
- Market Outlook
Chapter Two: Introduction
- Industry Development
- Generic Drug Industry Evolution
- FDA Regulation
- Development and Approval Process
- Industry Structure
- Product Distribution
- Patent Expirations
Chapter Three: Allergy and Respiratory Drugs
- Product Categories
- Asthma, Bronchodilators and Corticosteroids
- Inhaled Corticosteroids
- Antiasthmatic Agents
- Bronchodilating Agents
- Antihistamines, Decongestants, and Cough Preparations
- Antihistamines
- Decongestants
- Cough Preparations
- Product News
- Market Size and Forecast
- The World Market
- The U.S. vs World Market
- Competitive Analysis
Chapter Four: Analgesics, Nonsteroidal Anti-Inflammatory Drugs, and Antirheumatic Drugs
- Product Categories
- Analgesics
- Nonsteroidal Anti-inflammatory Drugs
- Antirheumatics
- Product News
- Market Size and Forecast
- The World Market
- The U.S. vs World Market
- Competitive Analysis
Chapter five: Anesthesia Drugs
- Product Categories
- Product News
- Market Size and Forecast
- The World Market
- The U.S. vs World Market
- Competitive Analysis
Chapter Six: Anti-Infectives
- Product Categories
- Systemic Anti-Infectives
- Topical Anti-Infectives
- Product News
- Market Size and Forecast
- The World Market
- The U.S. vs World Market
- Competitive Analysis
Chapter seven: Cancer Drugs
- Products
- Product News
- Market Size and Forecast
- The World Market
- The U.S. vs World Market
- Competitive Analysis
Chapter Eight: 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
- Market Size and Forecast
- The World Market
- The U.S. vs. World Market
- Competitive Analysis
Chapter Nine: Central Nervous System and Psychotherapeutic Drugs
- Product Categories
- Antidepressants, Stimulants, and Antipsychotics
- Antidepressants
- Stimulants
- Antipsychotics
- Anticonvulsants, Antispasmodics, and Muscle Relaxants
- Anticonvulsants
- Antispasmodics
- Muscle Relaxants
- Parkinson’s Disease, Myasthenia Gravis, and Multiple Sclerosis
- Parkinson’s Disease
- Myasthenia Gravis
- Multiple Sclerosis
- Sedatives, Hypnotics, and Antianxiety Drugs
- Product News
- Market Size and Forecast
- The World Market
- The U.S. vs World Market
- Competitive Analysis
Chapter Ten: Gastrointestinal Drugs
- Product Categories
- Antidiarrheals
- Antinauseants
- Antispasmodics
- Antiulcer
- Digestants
- Product News
- Market Size and Forecast
- The World Market
- The U.S. vs the World Market
- Competitive Analysis
Chapter Eleven: Hormonal Drugs
- Product Categories
- Male and Female Hormones
- Corticosteroids
- Diabetes Drugs
- Thyroid Drugs
- Product News
- Market Size and Forecast
- The World Market
- U.S. vs World Market
- Competitive Analysis
Chapter Twelve: Ophthalmic Drugs
- Product Categories
- Ophthalmic Anti-Infectives
- Ophthalmic Anti-Inflammatories and Mast Cell Inhibitors
- Glaucoma Agents
- Product News
- Market Size and Forecast
- The World Market
- U.S. vs World Market
- Competitive Analysis
Chapter Thirteen: World Market Summary
- Overview
- Total Market Size and Forecast
- Market and Competitive Analysis
Chapter Fourteen: 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
- 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
Chapter Fifteen: 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
Appendix: Company Directory
List of Exhibits
Chapter One: Executive Summary
- Table 1-1: Market Suumary: World Market for Prescription Generic Drugs Revenues by Segment 2000-2010
- Figure 1-1: Market Summary: Trending in the World Market for Prescription Generic Drugs by Segment 2000-2010
Chapter Two: Introduction
- Figure 2-1: Abbreviated New Drug Application Review Flow Chart
- Table 2-1: Brand Name Companies with Generic Subsidiaries
- Table 2-2: Number of Best Selling Drugs with Patents Expiring in Years 2006-2012 Grouped by Treatment Category
- Table 2-3: Best Selling Prescription Drugs with Expected Patent Expirations (Year of Expiration, Brand, Manufacturer, Indication,
- 2004 Revenues) 2006-2012
Chapter Three: Allergy and Respiratory Drugs
- Table 3-1: Prescription Allergy and Respiratory ANDA Approvals, 2005
- Table 3-2: The World Market for Prescription Generic Allergy and Respiratory Drugs by Type 2000-2010
- Figure 3-1: The World Market for Prescription Generic Allergy and Respiratory Drugs, Revenues by Type 2000-2010
- Table 3-3: The World Market for Prescription Generic Allergy and Respiratory Drugs, Market Share by Type 2000-2010
- Table 3-4: The World Market for Prescription Generic Allergy and Respiratory Drugs, U.S. Revenues and Share 2000-2010
- Figure 3-2: The World Market for Prescription Generic Allergy and Respiratory Drugs, Displaying U.S. Revenues 2000-2010
- Table 3-5: The World Market for Prescription Generic Allergy and Respiratory Drugs, Revenues and Market Share by Supplier 2005
- Figure 3-3: The World Market for Prescription Generic Allergy and Respiratory Drugs, Market Share by Leading Supplier 2005
Chapter Four: Analgesics, Nonsteroidal Anti-Inflammatory Drugs, and Antirheumatic Drugs
- Table 4-1: Prescription Generic Analgesic, NSAID, and Antirheumatic ANDA Approvals, 2005
- Table 4-2: The World Market for Prescription Generic Analgesics, NSAIDs and Antirheumatic Drugs by Type 2000-2010
- Figure 4-1: The World Market for Prescription Generic Analgesics, NSAIDs, and Antirheumatic Drugs, Revenues by Type 2000-2010
- Table 4-3: The World Market for Prescription Generic Analgesics, NSAIDs, and Antirheumatic Drugs, Market Share by Type 2000-2010
- Table 4-4: The World Market for Prescription Generic Analgesics, NSAIDs, and Antirheumatic Drugs, U.S. Revenues and Share 2000-2010
- Figure 4-2: The World Market for Prescription Generic Analgesics, NSAIDs, and Antirheumatic Drugs Displaying U.S. Revenues 2000-2010
- Table 4-5: The World Market for Prescription Generic Analgesics, NSAIDs, and Antirheumatic Drugs Revenues and Market Share by Supplier 2005
- Figure 4-3: The World Market for Prescription Generic Analgesics, NSAIDs, and Antirheumatic Drugs Market Share by Leading Supplier 2005
Chapter Five: Anesthesia Drugs
- Table 5-1: Prescription Generic Anesthesia Drug ANDA Approvals, 2005
- Table 5-2: The World Market for Prescription Generic Anesthesia Drugs 2000-2010
- Figure 5-1: The World Market for Prescription Generic Anesthesia Drugs Revenues 2000-2010
- Table 5-3: The World Market for Prescription Generic Anesthesia Drugs, U.S. Revenues and Share 2000-2010
- Figure 5-2: The World Market for Prescription Generic Anesthesia Drugs Displaying U.S. Revenues 2000-2010
- Table 5-4: The World Market for Prescription Generic Anesthesia Drugs, Revenues and Market Share by Supplier 2005
- Figure 5-3: The World Market for Prescription Generic Anesthesia Drugs Market Share by Leading Supplier 2005
CHAPTER Six: Anti-Infectives
- Table 6-1: Prescription Generic Anti-infective Drug ANDA Approvals, 2005
- Table 6-2: The World Market for Prescription Generic Anti-Infective Drugs by Type 2000-2010
- Figure 6-1: The World Market for Prescription Generic Anti-Infective Drugs, Revenues by Type 2000-2010
- Table 6-3: The World Market for Prescription Generic Anti-Infective Drugs, Market Share by Type 2000-2010
- Table 6-4: The World Market for Prescription Generic Anti-Infective Drugs U.S. Revenues and Share 2000-2010
- Figure 6-2: The World Market for Prescription Generic Anti-Infective Drugs Displaying U.S. Revenues 2000-2010
- Table 6-5: The World Market for Prescription Generic Anti-Infective Drugs, Revenues and Market Share by Supplier 2005
- Figure 6-3: The World Market for Prescription Generic Anti-Infective Drugs Market Share by Leading Supplier 2005
Chapter Seven: Cancer Drugs
- Table 7-1: Prescription Generic Cancer Drug ANDA Approvals 2005
- Table 7-2: The World Market for Prescription Generic Cancer Drugs 2000-2010
- Figure 7-1: The World Market for Prescription Generic Cancer Drugs Revenues 2000-2010
- Table 7-3: The World Market for Prescription Generic Cancer Drugs, U.S. Revenues and Share 2000-2010
- Figure 7-2: The World Market for Prescription Generic Cancer Drugs Displaying U.S. Revenues 2000-2010
- Table 7-4: The World Market for Prescription Generic Cancer Drugs, Revenues and Market Share by Supplier 2005
- Figure 7-3: The World Market for Prescription Generic Cancer Drugs Market Share by Leading Supplier 2005
Chapter Eight: Cardiovascular Drugs
- Table 8-1: Prescription Generic Cardiovascular Drug ANDA
- Approvals. 2005
- Table 8-2: The World Market for Prescription Generic Cardiovascular Drugs by Type 2000-2010
- Figure 8-1: The World Market for Prescription Generic Cardiovascular Drugs Revenues by Type 2000-2010
- Table 8-3: The World Market for Prescription Generic Cardiovascular Drugs, Market Share by Type 2000-2010
- Figure 8-2: The World Market for Prescription Generic Cardiovascular Drugs, Share by Type 2005 and 2010
- Table 8-4: The World Market for Prescription Generic Cardiovascular Drugs U.S. Revenues and Share 2000-2010
- Figure 8-3: The World Market for Prescription Generic Cardiovascular Drugs Displaying U.S. Revenues 2000-2010
- Table 8-5: The World Market for Prescription Generic Cardiovascular Drugs, Revenues and Market Share by Supplier 2005
- Figure 8-4: The World Market for Prescription Generic Cardiovascular Drugs, Market Share by Leading Supplier 2001
Chapter Nine: Central Nervous System and Psychotherapeutic Drugs
- Table 9-1: Prescription Generic Central Nervous System/Psychotherapeutic Drug ANDA Approvals 2005
- Table 9-2: The World Market for Prescription Generic Central Nervous System Drugs by Type 2000-2010
- Figure 9-1: The World Market for Prescription Generic Central Nervous System Drugs Revenues by Type 2000-2010
- Table 9-3: The World Market for Prescription Generic Central Nervous System Drugs, Market Share by Type 2000-2010
- Table 9-4: The World Market for Prescription Generic Central Nervous System Drugs, U.S. Revenues and Share 2000-2010
- Figure 9-2: The World Market for Prescription Generic Central Nervous System Drugs Displaying U.S. Revenues 2000-2010
- Table 9-5: The World Market for Prescription Generic Central Nervous System Drugs, Revenues and Market Share by Supplier 2005
- Figure 9-3: The World Market for Prescription Generic Central Nervous System Drugs, Market Share by Leading Supplier 2005
Chapter Ten: Gastrointestinal Drugs
- Table 10-1: Prescription Generic Gastrointestinal Drug ANDA Approvals 2005
- Table 10-2: The World Market for Prescription Generic Gastrointestinal Drugs by Type, 2000-2010
- Figure 10-1: The World Market for Prescription Generic Gastrointestinal Drugs Revenues by Type 2000-2010
- Table 10-3: The World Market for Prescription Generic Gastrointestinal Drugs, Market Share by Type 2000-2010
- Figure 10-2: The World Market for Prescription Generic Gastrointestinal Drugs, Share by Type 2005 and 2010
- Table 10-4: The World Market for Prescription Generic Gastrointestinal Drugs, U.S. Revenues and Share 2000-2010
- Figure 10-3: The World Market for Prescription Generic Gastrointestinal Drugs, Displaying U.S. Revenues 2000-2010
- Table 10-5: The World Market for Prescription Generic Gastrointestinal Drugs, Revenues and Market Share by Supplier 2005
- Figure 10-4: The World Market for Prescription Generic Gastrointestinal Drugs, Market Share by Leading Supplier 2005
Chapter Eleven: Hormonal Drugs
- Table 11-1: Prescription Generic Hormone Drug ANDA Approvals 2005
- Table 11-2: The World Market for Prescription Generic Hormone Drugs by Type 2000-2010
- Figure 11-1: The World Market for Prescription Generic Hormone Drugs Revenues by Type 2000-2010
- Table 11-3: The World Market for Prescription Generic Hormone Drugs, Market Share by Type 2000-2010
- Figure 11-2: The World Market for Prescription Generic Hormone Drugs Share by Type 2005 and 2010
- Table 11-4: The World Market for Prescription Generic Hormone Drugs U.S. Revenues and Share 2000-2010
- Figure 11-3: The World Market for Prescription Generic Hormone Drugs Displaying U.S. Revenues 2000-2010
- Table 11-5: The World Market for Prescription Generic Hormone Drugs, Revenues and Market Share by Supplier 2005
- Figure 11-4: The World Market for Prescription Generic Hormone Drugs Market Share by Leading Supplier 2005
Chapter Twelve: Ophthalmic Drugs
- Table 12-1: Prescription Generic Ophthalmic Drug ANDA Approvals 2001
- Table 12-2: The World Market for Prescription Generic Ophthalmic Drugs by Type 2000-2010
- Figure 12-1: The World Market for Prescription Generic Ophthalmic Drugs Revenues by Type 2000-2010
- Table 12-3: The World Market for Prescription Generic Ophthalmic Drugs, Market Share by Type 2000-2010
- Table 12-4: The World Market for Prescription Generic Ophthalmic Drugs, U.S. Revenues and Share 2000-2010
- Figure 12-2: The World Market for Prescription Generic Ophthalmic Drugs Displaying U.S. Revenues 2000-2010
- Table 12-5: The World Market for Prescription Generic Ophthalmic Drugs, Revenues and Market Share by Supplier 2005
- Figure 12-3: The World Market for Prescription Generic Ophthalmic Drugs Market Share by Leading Supplier 2005
Chapter Thirteen: World Market Summary
- Table 13-1: The World Market for Prescription Generic Drugs Revenues by Segment 2000-2010
- Figure 13-1: The World Market for Prescription Generic Drugs Revenues by Segment 2000-2010
- Figure 13-2: The World Market for Generic Drugs Market Share by Type 2005 and 2010
- Table 13-3: World Market for Prescription Generic Drugs Revenues and Segments of Participation by Leading Player 2005
Chapter Fourteen: Issues and Trends
- Table 14-1: Reorganization of Major Japanese Generic Drug Manufacturers