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The Market for Rx-to-OTC Switches, 3rd Edition


Attention: There is an updated edition available for this report.

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

    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

    • Pain
    • Inflammation

    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

    • Markets by Segments

    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

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