Description
Switching dosages and ingredients of prescription medicines to the over-the-counter market is not new. In the past 30 years, more than 70 switches have produced hundreds of brands competing in the consumer market, and the pace promises to accelerate.
Going OTC is one of a number of strategies marketers can use to extend the revenue life of their products. Appropriately coordinating the switch with patent expiry, creating coherent branding strategies, and knowing the clinical consumer climate are all factors in a successful switch.
This study, the third time Kalorama has looked at the market, examines the current environment for OTC switches and pegs the market size and growth and competitive market share for various segments through 2007, identifying likely and unlikely switches and their potential.
Table of Contents
Executive Summary
- Scope and Methodology
- Size and Growth of the Market
- Issues and Trends Affecting the Rx-to-OTC Switches Market
- Leading Competitors
Introduction
- Overview of the Over-the-Counter Market
- Development of the Rx-to-OTC Drug Market
- Rx-to-OTC Industry Structure
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
- Prescription Products with Anticipated OTC Approvals
- Market Analysis
- Market Size and Forecast
- Competitive Analysis
Analgesics, NSaids, And Topical Pain Relievers
- Overview
- Analgesics
- Nonsteroidal Anti-inflammatory Drugs
- Topical Pain Relievers and Other Similar Products
- Description of Conditions
- Prevalence and Incidence
- Product Analysis
- Current OTC Switched Products
- Prescription Products with Anticipated OTC Approvals
- Market Analysis
- Market Size and Forecast
- Competitive Analysis
Anti-Infectives
- Overview
- Antibiotics
- Antifungals
- Antivirals
- Antiparasitics
- Description of Conditions
- Vaginal Infections
- Athlete’s Foot
- Jock Itch
- Ringworm
- Dandruff
- Scabies and Pediculosis
- Pinworm
- Prevalence and Incidence
- Product Analysis
- Current OTC Switched Products
- Prescription Products with Anticipated OTC Approvals
- Market Analysis
- Market Size and Forecast
- Competitive Analysis
Gastrointestinal Drugs
- Overview
- Description of Conditions
- Nausea
- Diarrhea
- Heartburn
- Acid reflux
- Prevalence and Incidence
- Product Analysis
- Current OTC Switched Products
- Prescription Products with Anticipated OTC Approvals
- Market and Competitive Analysis
- Market Size and Forecast
- Competitive Analysis
Smoking Cessation
- Overview
- Description of Conditions
- Prevalence and Incidence
- Product Analysis
- Current OTC Switched Products
- Prescription Products with Anticipated OTC Approvals
- Market Analysis
- Market Size and Forecast
- Competitive Analysis
Miscellaneous Drugs
- Overview
- Dental Rinses and Fluorides
- Hair Growth Products
- Rectal Ointments
- Sleep Aids
- Description of Conditions
- Dental Carries
- Hereditary Hair Loss
- Hemorrhoids
- Sleeplessness
- Conditions with Possible Future OTC Treatments
- Elevated Cholesterol
- Osteoporosis
- Acne Vulgaris
- Menopause and Hormone Replacement
- Pregnancy Prevention
- Prevalence and Incidence
- Product Analysis
- Current OTC Switched Products
- Prescription Products with Anticipated OTC Approvals
- Market Analysis
- Market Size and Forecast
- Competitive Analysis
Total Market Summary
- Overview
- Total market Size and Forecast
- Competitive Analysis
- Market Analysis
Issues And Trends Affecting The Rx-To-OTC Market
- Introduction
- Regulatory Authorities
- A Third Class of Drug
- Impact on the Insurance Company
- Pharmacists Role
- Impact on the Prescription Drug Manufacturer
- Strategies for Continued Product Growth—Dual Status Switching
- Impact on the Consumer
- Direct-to-Consumer Advertising
- Consumer Purchasing Trends
- Patent Expiration
- Labeling Changes
Company Profiles
Brand Company Profiles
- Bayer Consumer Care
- GlaxoSmithKline Consumer Healthcare
- Johnson & Johnson
- Merck Consumer Pharmaceuticals Company
- McNeil Consumer & Specialty Pharmaceuticals
- Novartis Consumer Health, Inc.
- Personal Products Company
- Pfizer Consumer Healthcare
- Pharmacia Consumer Healthcare
- Procter & Gamble Company, Health Care Division
- Schering-Plough HealthCare Products
- Wyeth Consumer Health Care
Generic and Private Label Company Profiles
- Alpharma U.S. Human Pharmaceuticals (USHP)
- IVAX Pharmaceuticals, Inc.
- Perrigo Company
- Watson Pharmaceuticals, Inc.
Company Directory
List of Exhibits
Chapter One: Executive Summary
- Table 1-1: The Total U.S. Market for Over-the-Counter Switches 1997-2007
- Figure 1-1: The U.S. Market for Rx-to-OTC Switches Revenues by Type 1997-2007
- Table 1-2: Leading Suppliers’ Significant Segments of Participation within the U.S. Market for Rx-to-OTC Switches, 2002
Chapter Two: Introduction
- Table 2-1: OTC Retail Sales, 1976-2001
- Table 2-2: Rx-to-OTC Switches Approved by the FDA 1976-2003
- Table 2-3: Statistics for Selected Rx-to-OTC Switches
- 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
- Table 2-6: Healthcare Industry Inflation Rates Healthcare Industry Consumer Price Index Comparisons Based on 2002 Data
- Figure 2-1: Healthcare Industry Inflation Rates Healthcare Industry Consumer Price Index Comparisons Based on 2002 Data
Chapter Three: Allergy, Cough, Cold, And Sinus Products
- Table 3-1: United States Incidence of Allergy, Cough, Cold, Sinus Conditions 2002
- Figure 3-1: United States Incidence of Allergy, Cough, Cold, Sinus Conditions, Superimposed on Total Population, 2002
- 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 1997-2007
- Figure 3-2: The U.S. Market for Rx-to-OTC Switches Allergy, Cough, Cold, and Sinus Product Revenues 1997-2007
- Table 3-5: The U.S. Market for Rx-to-OTC Switches Allergy, Cough, Cold, and Sinus Products Revenues by Type 1997-2007
- Table 3-6: The U.S. Market for Rx-to-OTC Switches Allergy, Cough, Cold, and Sinus Products Distribution of Revenues by Product Type 1997-2007
- Figure 3-3: The U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, and Sinus Products, by Product Type and Revenues, 1997-2007
- Figure 3-4: The U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, and Sinus Products, by Percent and Product Type, 2002
- Table 3-7: Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, and Sinus Products, 2002
- Figure 3-5: Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, and Sinus Products, 2002
Chapter Four: Analgesics, Nsaids, And Topical Pain Relievers
- Table 4-1: United States Incidence of Conditions with Pain and Inflammatory Symptoms 2002
- Figure 4-1: United States Incidence of Conditions with Pain and Inflammatory Symptoms Superimposed on Total Population, 2002
- 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 Analgesics, NSAIDs, and Other Drugs Total Revenues 1997-2007
- Figure 4-2: The U.S. Market for Rx-to-OTC Switches: Analgesics, NSAIDs, and Other Drugs, 1997-2007
- Table 4-5: The U.S. Market for Rx-to-OTC Switches Analgesics, NSAIDs, and Other Drugs Revenues by Product Type 1997-2007
- Table 4-6: The U.S. Market for Rx-to-OTC Switches Analgesics, NSAIDs, and Other Drugs Distribution of Revenues by Product Type 1997-2007
- Figure 4-3: The U.S. Market for Rx-to-OTC Switches Analgesics, NSAIDs, and Other Drugs Revenues by Product Type 1997-2007
- Figure 4-4: The U.S. Market for Rx-to-OTC Switches Analgesics, NSAIDs, and Other Drugs Distribution of Revenues by Product Type 2002
- Table 4-7: Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Analgesics, NSAIDs, and Other Drugs 2002
- Figure 4-5: Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Analgesics, NSAIDs, and Other Drugs 2002
Chapter Five: Anti-Infectives
- Table 5-1: United States Yearly Incidence of Infections, 2002
- Figure 5-1: United States Yearly Incidence of Infections Superimposed on Total Population, 2002
- 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-infectives 1997-2007
- Figure 5-2: The U.S. Market for Rx-to-OTC Switches Anti-infectives, 1997-2007
- Table 5-5: The U.S. Market for Rx-to-OTC Switches Anti-infectives by Product Type 1997-2007
- Table 5-6: The U.S. Market for Rx-to-OTC Switches, Anti-infectives Distribution of Revenues by Product Type 1997-2007
- Figure 5-3: The U.S. Market for Rx-to-OTC Switches Anti-infectives by Product Type, 1997-2007
- Figure 5-4: The U.S. Market for Rx-to-OTC Switches, Anti-infectives Revenue Distribution by Product Type 2002
- Table 5-7: Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switched Anti-infectives 2002
- Figure 5-5: Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switched Anti-infectives 2002
Chapter Six: Gastrointestinal Drugs
- Table 6-1: United States Incidence of Gastrointestinal Conditions 2002
- Figure 6-1: United States Incidence of Gastrointestinal Conditions Superimposed on General Population 2002
- 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 Drugs 1997-2007
- Figure 6-2: The U.S. Market for Rx-to-OTC Switches Gastrointestinal Drugs 1997-2007
- Table 6-5: The U.S. Market for Rx-to-OTC Switches Gastrointestinal Drugs by Product Type 1997-2007
- Table 6-6: The U.S. Market for Rx-to-OTC Switches Gastrointestinal Drugs Distribution of Revenues by Product Type 1997-2007
- Figure 6-3: The U.S. Market for Rx-to-OTC Switches Gastrointestinal Drugs by Product Type 1997-2007
- Figure 6-4: The U.S. Market for Rx-to-OTC Switches Gastrointestinal Drugs Distribution of Revenues by Product Type 2002
- Table 6-7: Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Gastrointestinal Drugs 2002
- Figure 6-5: Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Gastrointestinal Drugs 2002
Chapter Seven: Smoking Cessation
- Table 7-1: United States Cigarette Usage in Percent by Age Group, 2002
- Figure 7-1: United States Cigarette Usage in Percent by User Type 2002
- Table 7-2: Lung Cancer in the United States Estimated New Cases and Deaths 2002
- 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 Drugs 1997-2007
- Figure 7-2: The U.S. Market for Rx-to-OTC Switches Smoking Cessation Drugs 1997-2007
- Table 7-6: The U.S. Market for Rx-to-OTC Switches Smoking Cessation Drugs Revenues by Product Type 1997-2007
- Table 7-7: The U.S. Market for Rx-to-OTC Switches Smoking Cessation Drugs Distribution of Revenues by Product Type 1997-2007
- Figure 7-3: The U.S. Market for Rx-to-OTC Switches Smoking Cessation Drugs Revenues by Product Type 1997-2007
- Figure 7-4: The U.S. Market for Rx-to-OTC Switches Smoking Cessation Drugs Distribution of Revenue by Product Type 2002
- Table 7-8: Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Smoking Cessation Drugs 2002
- Figure 7-5: Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Smoking Cessation Drugs 2002
Chapter Eight: Miscellaneous Drugs
- Table 8-1: United States Incidence of Miscellaneous Conditions for Which There Are Potential Rx-to-OTC Switches 2002
- Table 8-2: 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 Miscellaneous Drugs Revenues by Product Type 1997-2007
- Table 8-5: The U.S. Market for Rx-to-OTC Switches Miscellaneous Drugs Distribution of Revenues by Product Type 1997-2007
- Figure 8-1: The U.S. Market for Rx-to-OTC Switches Miscellaneous Drugs Revenues by Product Type 1997-2007
- Figure 8-2: The U.S. Market for Rx-to-OTC Switches Miscellaneous Dugs Distribution of Revenues by Product Type 2002
- Table 8-6: Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Miscellaneous Drugs 2002
- Figure 8-3: Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Miscellaneous Drugs 2002
Chapter Nine: Total Market Summary
- Table 9-1: The U.S. Market for Rx-to-OTC Switches 1997-2007
- Figure 9-1: The U.S. Market for Rx-to-OTC Switches, 1997-2007
- Table 9-2: The U.S. Market for Rx-to-OTC Switches by Type, 1997-2007
- Table 9-3: The U.S. Market for Rx-to-OTC Switches Revenue Distribution by Segment 1997-2007
- Figure 9-2: The U.S. Market for Rx-to-OTC Switches by Type and Revenues, 1997-2007
- Figure 9-3: The U.S. Market for Rx-to-OTC Switches by Type and Percent Distribution, 1997-2007
- Figure 9-4: The U.S. Market for Rx-to-OTC Switches by Percent and Segment, 2002
- Table 9-4: Leading Suppliers Significant Segments of Participation within the U.S. Market for Rx-to-OTC Switches, 2002
Chapter Ten: Issues and Trends Affecting the Rx-to-OTC Market
Figure 10-1: Typical Pharmacist-Consumer OTC Drug Counseling Session
Table 10-1: Health Insurance Coverage Status by Selected Characteristics, 1990-2000
Table 10-2: Average Annual Expenditures per Consumer Unit for Healthcare 1990-2000
Table 10-3: Estimated Direct-to-Consumer Advertising Expenditures by Drug and Marketer