Table of Contents
List of Exhibits
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
- Economic Indicators
- The FDA and Rx-to-OTC Switches
Chapter Three
Allergy, Cough, Cold, and Sinus Products
Overview
- Antihistamines
- Decongestants
- Cough Preparations
- Mast Cell Stabilizers
- Ophthalmic Preparations
Description of Conditions
- Allergic Rhinitis
- Common Cold
- Sinusitis
- Hives
- Ocular Allergies
Prevalence and Incidence
Product Analysis
- Current OTC Switched Products
- Antihistamines
- Decongestants
- Cough Preparations
- Mast Cell Stabilizers
- Ophthalmic Preparations
- Prescription Products with Anticipated OTC Approvals
- Allegra
- Clarinex
- Flonase
- Nasacort AQ
- Nasonex
Market Analysis
- Market Size and Forecast
- Competitive Analysis
Chapter Four
Analgesics and Other Pain Relievers
Overview
- Analgesics
- Nonsteroidal Anti-inflammatory Drugs
- Topical Pain Relievers and Other Similar Products
Description of Conditions
- Pain
- Inflammation
Prevalence and Incidence
Product Analysis
- Current OTC Switched Products
- Antipruritic
- Internal analgesic/antipyretic
- Oral anesthetic
- Prescription Products with Anticipated OTC Approvals
- Nonsteroidal anti-inflammatory drugs
- Migraine treatments
Market Analysis
- Market Size and Forecast
- Competitive Analysis
Chapter Five
Anti-infectives
Overview
- Antibiotics
- Antifungals
- Antivirals
- Antiparasitics
Description of Conditions
- Vaginal Infections
- Athlete’s Foot
- Jock Itch
- Ringworm
- Dandruff
- Scabies and Pediculosis
- Pinworm
- Fungal Nail Infections
Prevalence and Incidence
Product Analysis
- Current OTC Switched Products
- Prescription Products with Anticipated OTC Approvals
- Antivirals
- Antibiotics
- Antifungals
Market Analysis
- Market Size and Forecast
- Competitive Analysis
Chapter Six
Gastrointestinal Drugs
Overview
Description of Conditions
- Nausea
- Diarrhea
- Constipation
- Heartburn
- Acid reflux
Prevalence and Incidence
Product Analysis
- Current OTC Switched Products
- Histamine H2 Inhibitors
- Proton Pump Inhibitors
- Antidiarrheals
- Laxatives
- Antiemetics
- Prescription Products with Anticipated OTC Approvals
- Proton Pump Inhibitors
- Mucosal Protectants
- Antiemetics
Market and Competitive Analysis
- Market Size and Forecast
- Competitive Analysis
Chapter Seven
Smoking Cessation
Overview
Description of Conditions
Prevalence and Incidence
- Lung Cancer and Tobacco Use
Product Analysis
- Current OTC Switched Products
- Prescription Products with Anticipated OTC Approvals
Market Analysis
- Market Size and Forecast
- Competitive Analysis
Chapter Eight
Other Drug Classifications
Overview
- Contraceptives
- Dental Rinses and Fluorides
- Hair Growth Products
- Rectal Ointments
- Sleep Aids
- Weight Management
Description of Conditions
- Pregnancy
- Dental carries
- Hereditary Hair Loss
- Hemorrhoids
- Sleeplessness
- Obesity
Conditions with Possible Future OTC Treatments
- Elevated Cholesterol
- Osteoporosis
- Acne Vulgaris
- Menopause and Hormone Replacement
Prevalence and Incidence
Product Analysis
- Current OTC Switched Products
- Contraceptives
- Dental rinses and fluoride
- Hair growth
- Rectal ointments
- Sleep aids
- Weight Management
- Prescription Products with Anticipated OTC Approvals
- Antilipidemics/ Osteoporosis/ Hormone Replacement
- Hair Loss Treatment
- Acne Treatments
- Overactive Bladder
- Sexual Dysfunction
Market Analysis
- Market Size and Forecast
- New Product Segments; Post 2013
- Osteoporosis and Hormone Replacement
- Overactive Bladder
- Sexual Dysfunction
- Competitive 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
- 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
- World Health, Demographics and Life Expectancy
- Life Expectancy
- Declining Growth of the World Population
- Birth Rates
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
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