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.
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
Analgesics, NSaids, And Topical Pain Relievers
Anti-Infectives
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
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
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