Rx to OTC Switches 2009

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Publication Date: 2009-05-01

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While many areas of the pharmaceutical industry will suffer from current economic conditions worldwide, sales of over the counter drugs are widely anticipated to grow as consumers seek cheaper alternatives. Manufacturers are expected to switch prescription drugs to over the counter status where possible. In the early part of this decade there was a delcine in Rx to switches, since 2006 there has been a number of uses of this tactic to extend revenue of pharmaceutical products. Rx to OTC Switches 2009 takes a look at recent swtiches, products that may switch in the future, and categories that can benefit most from an OTC product.

The U.S. market for Rx-to-OTC Switches encompasses a wide variety of products that have been determined safe and effective as over-the-counter products. The market is fueled by several factors including an aging population; steady to increased incidences of conditions and diseases; new drug classes switched to OTC; product demand; economic conditions and several other factors.

All product areas contribute to the growth and development of the OTC market; however, new product development and additional regulatory review and approval of new OTC drug classifications, specifically in areas such as gastrointestinal drugs, cholesterol-reducing drugs, and contraceptives are expected to make the most impact for continued growth.

As part of its coverage, this report includes

Current Market for Rx to OTC across major categories
Past Results of OTC Switches
Products Most Likely to Switch to OTC
Assessment of the Economic Downturn's Impact

The U.S. Market for Rx-to-OTC Switches focuses on several treatment segments in which Rx-to-OTC switches are available:

Allergy, Cough, Cold, and Sinus Products
Analgesics, NSAIDs, and Pain Treatments
Anti-Infectives
Gastrointestinal Drugs
Hair Loss Products
Hormones
Oral Care
Rectal Ointments
Sleep-aids
Smoking Cessation
Weight Loss

In addition to the areas with switches in place, this report has identified other areas which may be open to Rx-to-OTC switches in the future, including: Cholesterol-reducing Drugs, Osteoporosis Treatments, Overactive Bladder and Sexual Dysfunction. The report covers OTC drugs that were once only available by prescription due to either the active ingredient or dosage of the drug.

Current and historical revenues for product segments include both the switched brands and OTC drugs containing switched ingredients. Forecasted data includes current products and forecasted switches which are outlined in the report.

The report includes statistical information for conditions and diseases affecting the U.S. population, including detail discussions, tables and figures. Each segment provides an overview, descriptions of products on the market, market estimates and forecasts, and competitive analysis of leading providers. In addition to above-mentioned information, the report includes current issues and trends affecting the industry and identifies trends that may arise in the future, including:

Regulatory Actions
A Third Class of Drug
Insurance Issues and Reimbursement for OTC Drugs
Health Insurance Trends in the United States
Healthcare Flexible Spending Accounts and OTC Medicines: Impact on the Consumer
Online Resources for Health Information
OTC Availability
Health Expenditures
Pharmacists Role
Impact on the Prescription Drug Manufacturer
Strategies for Continued Product Growth
Dual Status Switching
Generic Competition
Direct-to-Consumer Advertising
Patent Expiration
Labeling Changes
International Trends in Rx-to-OTC Switches
Prescription vs Over-the-Counter Industry
Declining Growth of the World Population

Chapter One: Executive Summary: Scope and Methodology; Size and Growth of the Market; Issues and Trends Affecting the Rx-to-OTC Switches Market; Leading Competitors
Chapter Two
Introduction: Overview of the Over-the-Counter Market; Development of the Rx-to-OTC Drug Market; Rx-to-OTC Industry Structure
Chapter Three
Allergy, Cough, Cold, and Sinus Products: Overview; Description of Conditions; Prevalence and Incidence; Product Analysis; Market Analysis
Chapter Four
Analgesics and Other Pain Relievers: Overview; Description of Conditions; Prevalence and Incidence; Product Analysis; Market Analysis
Chapter Five
Anti-infectives: Overview; Description of Conditions; Prevalence and Incidence; Product Analysis; Market Analysis
Chapter Six
Gastrointestinal Drugs: Overview; Description of Conditions; Prevalence and Incidence; Product Analysis; Market and Competitive Analysis
Chapter Seven
Smoking Cessation: Overview; Description of Conditions; Prevalence and Incidence; Product Analysis; Market Analysis
Chapter Eight
Other Drug Classifications: Overview; Description of Conditions; Conditions with Possible Future OTC Treatments; Prevalence and Incidence; Product Analysis; Market Analysis
Chapter Nine
Total Market Summary: Overview; Total market Size and Forecast; Competitive Analysis; Market Analysis
Chapter Ten: Issues and Trends Affecting the Rx-to-OTC Market: Introduction; Regulatory Authorities; A Third Class of Drug; Insurance Issues and Reimbursement for OTC Drugs; Impact on the Consumer; Pharmacists Role; Impact on the Prescription Drug Manufacturer; Strategies for Continued Product Growth; Patent Expiration; Labeling Changes; International Trends in Rx-to-OTC Switches
Chapter Eleven: Company Profiles: Introduction; GlaxoSmithKline; Johnson & Johnson; Novartis; Procter & Gamble; Schering-Plough; Wyeth
APPENDIX: Company Directory
Table of Contents
List of Exhibits
Chapter One
Executive Summary: Table 1-1 - The U.S. Market for Rx-to-OTC Switches 2004-2013; Compound Annual Growth Rate; Figure 1-1 - The U.S. Market for Rx-to-OTC Switches, 2004-2013
Chapter Two
Introduction: Table 2-1 - OTC Retail Sales, 1976-2007; Table 2-2 - Rx-to-OTC Switches Approved by the FDA 1976-2007; Figure 2-1 - Number of New Rx-to-OTC Switches per Year 1976-2007; Table 2-3 - Statistics for Selected Rx-to-OTC Switches (United States); Table 2-4 - Estimated OTC Sales by Product Type and Percent of Sales Attributed to Rx-to-OTC Switched Ingredients; Table 2-5 - U.S. Population by Sex and Selected Age Group, 1997-2017; Figure 2-2 - U.S. Population by Sex, 1997-2017; Figure 2-3 - U.S. Population by Selected Age Group, 1997-2017; Table 2-6 - Healthcare Industry Inflation Rates Healthcare Industry Consumer Price Index Comparisons Based on 2008 Data; Figure 2-4 - Healthcare Industry Inflation Rates Healthcare Industry Consumer Price Index Comparisons Based on 2008 Data
Chapter Three
Allergy, Cough, Cold, and Sinus Products: Table 3-1 - United States Incidence of Allergy, Cough, Cold, Sinus Conditions 2008; Figure 3-1 - United States Incidence of Allergy, Cough, Cold, Sinus Conditions, Superimposed on Total Population, 2008; Table 3-2 - Allergy, Cough, Cold, Sinus Product Ingredients Transferred from Rx-to-OTC Status by Trade Name, Distributor, and Date of OTC Approval; Table 3-3 - Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name, Distributor and Current Activity; Table 3-4 - The U.S. Market for Rx-to-OTC Switches Allergy, Cough, Cold, and Sinus Product Revenues 2004-2008; Compound Annual Growth Rate; Table 3-5 - The Forecasted U.S. Market for Rx-to-OTC Switches Allergy, Cough, Cold, and Sinus Product Revenues 2009-2013; Compound Annual Growth Rate; Figure 3-2 - The U.S. Market for Rx-to-OTC Switches Allergy, Cough, Cold, and Sinus Product Revenues 2004-2013; Figure 3-3 - The U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, and Sinus Products, by Percent and Product Type, 2008; Table 3-6 - Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, and Sinus Products, 2008; Figure 3-4 - Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, and Sinus Products, 2008
Chapter Four
Analgesics and Other Pain Relievers: Table 4-1 - United States Incidence of Conditions with Pain and Inflammatory Symptoms 2008; Figure 4-1 - United States Incidence of Conditions with Pain and Inflammatory Symptoms Superimposed on Total Population, 2008; Table 4-2 - Analgesics, NSAIDs and Other Ingredients Transferred from Rx-to-OTC Status by Trade Name, Distributor, and Date of OTC Approval; Table 4-3 - Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name, Distributor and Current Activity; Table 4-4 - The U.S. Market for Rx-to-OTC Switches Analgesic Product Revenues 2004-2008; Compound Annual Growth Rate; Table 4-5 - The Forecasted U.S. Market for Rx-to-OTC Switches Analgesic Product Revenues 2009-2013; Compound Annual Growth Rate; Figure 4-2 - The U.S. Market for Rx-to-OTC Switches Analgesic Product Revenues 2004-2013; Figure 4-3 - The U.S. Market for Rx-to-OTC Switches: Analgesic Product Type, 2008; Table 4-6 - Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Analgesics 2008; Figure 4-4 - Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Analgesics 2008
Chapter Five
Anti-infectives: Table 5-1 - United States Yearly Incidence of Infections, 2008; Figure 5-1 - United States Yearly Incidence of Infections Superimposed on Total Population, 2008; Table 5-2 - Anti-infectives Ingredients Transferred from Rx-to-OTC Status by Trade Name, Distributor, and Date of OTC Approval; Table 5-3 - Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name, Distributor and Current Activity; Table 5-4 - The U.S. Market for Rx-to-OTC Switches Anti-infective Product Revenues 2004-2008; Compound Annual Growth Rate; Table 5-5 - The Forecasted U.S. Market for Rx-to-OTC Switches Anti-infective Product Revenues 2009-2013; Compound Annual Growth Rate; Figure 5-2 - The U.S. Market for Rx-to-OTC Switches Anti-infective Product Revenues 2004-2013; Figure 5-3 - The U.S. Market for Rx-to-OTC Switches: Anti-infective Product Type, 2008; Table 5-6 - Leading Suppliers’ Shares of The U.S. Market for Rx-to-OTC Switched Anti-infectives 2008; Figure 5-4 - Leading Suppliers’ Shares of The U.S. Market for Rx-to-OTC Switched Anti-infectives 2008
Chapter Six
Gastrointestinal Drugs: Table 6-1 - United States Incidence of Gastrointestinal Conditions 2008; Table 6-2 - Gastrointestinal Drug Ingredients Transferred from Rx-to-OTC Status by Trade Name, Distributor, and Date of OTC Approval; Table 6-3 - Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name, Distributor and Current Activity; Table 6-4 - The U.S. Market for Rx-to-OTC Switches Gastrointestinal Drug Revenues 2004-2008; Compound Annual Growth Rate; Table 6-5 - The Forecasted U.S. Market for Rx-to-OTC Switches Gastrointestinal Drug Revenues 2009-2013; Compound Annual Growth Rate; Figure 6-2 - The U.S. Market for Rx-to-OTC Switches Gastrointestinal Drug Revenues 2004-2013; Figure 6-3 - The U.S. Market for Rx-to-OTC Switches: Gastrointestinal Drug by Product Type, 2008; Table 6-6 - Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Gastrointestinal Drugs 2008; Figure 6-4 - Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Gastrointestinal Drugs 2008
Chapter Seven
Smoking Cessation: Table 7-1 - United States Cigarette Usage in Percent by Age Group, 2006; Figure 7-1 - New Lung Cancer Cases and Deaths for 2008 by Gender, United States; Table 7-2 - New Cases of Lung and Bronchus Cancer by State; Deaths from Lung and Bronchus Cancer by State, 2008 Estimates; Table 7-3 - Smoking Cessation Product Ingredients Transferred from Rx-to-OTC Status by Trade Name, Distributor, and Date of OTC Approval; Table 7-4 - Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name, Distributor and Current Activity; Table 7-5 - The U.S. Market for Rx-to-OTC Switches Smoking Cessation Product Revenues 2004-2008; Compound Annual Growth Rate; Table 7-5 - The Forecasted U.S. Market for Rx-to-OTC Switches Smoking Cessation Product Revenues 2009-2013; Compound Annual Growth Rate; Figure 7-2 - The U.S. Market for Rx-to-OTC Switches Smoking Cessation Product Revenues 2004-2013; Figure 7-3 - The U.S. Market for Rx-to-OTC Switches: Smoking Cessation Product Type, 2008; Table 7-8 - Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Smoking Cessation Drugs 2008; Figure 7-5 - Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Smoking Cessation Drugs 2008
Chapter Eight
Other Drug Classifications: Table 8-1 - United States Incidence of Miscellaneous Conditions for Which There Are Potential Rx-to-OTC Switches 2008; Table 8-2 - Estimated U.S. Contraceptive Use by Method, Five Year Average 2007/2008; Table 8-3 - Miscellaneous Drug Ingredients Transferred from Rx-to-OTC Status by Trade Name, Distributor, and Date of OTC Approval; Table 8-3 - Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name, Distributor and Current Activity; Table 8-4 - The U.S. Market for Rx-to-OTC Switches Other Drug Classification Product Revenues 2004-2008; Compound Annual Growth Rate; Table 8-5 - The Forecasted U.S. Market for Rx-to-OTC Switches Other Drug Classification Product Revenues 2009-2013; Compound Annual Growth Rate; Figure 8-2 - The U.S. Market for Rx-to-OTC Switches Other Drug Classification Product Revenues 2004-2013; Table 8-6 - The U.S. Market for Rx-to-OTC Switches Other Drug Classifications Revenues by Product Type 2004-2013; Compound Annual Growth Rate; Figure 8-3 - The U.S. Market for Rx-to-OTC Switches Other Drug Classifications Revenues by Product Type 2004-2013; Figure 8-4 - The U.S. Market for Rx-to-OTC Switches Other Drug Classifications Distribution of Revenues by Product Type 2008; Table 8-7 - Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Other Drug Classifications 2008; Figure 8-5 - Leading Suppliers’ Shares of the U.S. Market for Rx-o-OTC Switches Other Drug Classifications 2008
Chapter Nine
Total Market Summary: Table 9-1 - The U.S. Market for Rx-to-OTC Switches 2004-2013; Compound Annual Growth Rate; Figure 9-1 - The U.S. Market for Rx-to-OTC Switches, 2004-2013; Markets by Segments; Figure 9-2 - The U.S. Market for Rx-to-OTC Switches by Product Category, 2004-2013; Figure 9-3 - The U.S. Market for Rx-to-OTC Switches, Distribution of Revenues by Product Category 2008; Table 9-4 - Leading Suppliers Significant Segments of Participation within the U.S. Market for Rx-to-OTC Switches, 2008; Figure 9-4 - Leading Suppliers Market Share in the U.S. Market for Rx-to-OTC Switches, 2008
Chapter Ten : Issues and Trends Affecting the Rx-to-OTC Market: Table 10-1: Health Insurance Trends in the United States 2003-2006; Table 10-2: National Healthcare Expenditures in the United States 1960-2010; Figure 10-1: Healthcare Spending as a Percent of GDP in the United States; Figure 10-2: Internet Users per 100 Inhabitants, 1994-2006; Table 10-3:Total Healthcare Expenditures as a Percent of GDP by Country 2004 and 2006; Figure 10-3: Total Healthcare Expenditures as a Percent of GDP by Country 2004 and 2006; Table 10-4: Average Annual Expenditures per Consumer Unit for Healthcare 2004-2006; Figure 10-4: Typical Pharmacist-Consumer OTC Drug Counseling Session; Table 10-5: U.S. Patent Expirations for Select Prescription Pharmaceuticals; Table 10-6: Legal Classification Status of Selected Ingredients Worldwide; Table 10-7: Total Pharmaceutical Markets, Prescription vs. Non-Prescription by Region, 2007; Figure 10-5: Total Pharmaceutical Markets, Prescription vs. Non-Prescription by Region, 2007; Table 10-8: Average Life Expectancy in Years by Country 1980 and 2008; Figure 10-6: Average Life Expectancy in Years by Country 1980 and 2008; Table 10-9: World Population 1980 to 2050; Figure 10-7: World Population 1980 to 2050; Table 10-10: Crude Birth Rate per 1,000 Persons 2000, 2005 and Projected 2010; Figure 10-8: Crude Birth Rate per 1,000 Persons 2000, 2005 and Projected 2010

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Rx to OTC Switches 2009

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