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The Market for Rx to OTC Switches, 5th Edition


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

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 the last decade there was a decline in Rx-to-OTC switches; since 2006, however, there has been a number of uses of this tactic to extend the revenue of pharmaceutical products. In Kalorama Information's Market for Rx to OTC Switches, we take a look at recent switches, 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 Situation
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
  • Oral Care
  • Smoking Cessation
  • Other Drugs, including:
    • Dental Rinses and Fluorides
    • Hair Growth Products
    • Rectal Ointments
    • Sleep Aids
    • Weight Management
    • Hormone Replacement

In addition to the areas with switches in place, Kalorama Information has identified other areas which may become 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 detailed 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.

Trends covered in the report include:

  • Healthcare Flexible Spending Accounts and OTC Medicines
  • A Third Class of Drug
  • Insurance Issues and Reimbursement for OTC Drugs
  • Health Insurance Trends in the United States
  • 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
  • Mergers and Acquisitions
  • Dual Status Switching
  • Generic Competition
  • Direct-to-Consumer Advertising
  • Patent Expiration
  • Labeling Changes
  • International Trends in Rx-to-OTC Switches
  • Consumers around the World
  • Prescription vs Over-the-Counter Industry
  • World Health, Demographics and Life Expectancy
  • Life Expectancy
  • Birth Rates
Companies profiled in this report include:
  • Bayer Healthcare
  • Boehringer Ingelheim
  • GlaxoSmithKline
  • Johnson & Johnson
  • Merck/ Schering-Plough
  • Novartis
  • Pfizer/Wyeth
  • Procter & Gamble
  • Reckitt Benckiser
  • Sanofi-Aventis/Chattem
The information for this report was gathered using both primary and secondary research including comprehensive research of secondary sources such as company literature, databases, investment reports, and medical and business journals. Person-to-person, email and telephone interviews were the primary method of gathering information. For the purpose of this study Kalorama Information conducted interviews with approximately 50 industry officials, consultants, health care providers, and government personnel. These sources were the primary basis in gathering information specifically relating to revenue and market share data presented in this report. Specific interviews with pharmaceutical company representatives included marketing directors, division managers, and product representatives.

All Kalorama reports advertise the single user price. Use is limited to one user. We also feature department and global pricing for reports that we be utilized by more than one user at your company. Please consult ask your sales representative or select the correct license on our website.

For Kalorama's take on the healthcare news of the week, based on our analysis of healthcare markets, follow Kalorama Information's Key Point Blog at http://kaloramakeypoint.blogspot.com/


  • Executive Summary
    • SCOPE AND METHODOLOGY
    • SIZE AND GROWTH OF THE MARKET
      • Table The U.S. Market for Rx-to-OTC Switches 2005-2015
    • ISSUES AND TRENDS AFFECTING THE RX-TO-OTC SWITCHES MARKET
    • LEADING COMPETITORS
  • Introduction
    • OVERVIEW OF THE OVER-THE-COUNTER MARKET
      • Table OTC Retail Sales, 1976-2009
    • DEVELOPMENT OF THE RX-TO-OTC DRUG MARKET
      • Table Rx-to-OTC Switches Approved by the FDA 1976-2010
      • Table Statistics for Selected Rx-to-OTC Switches (United States)
      • Table Estimated OTC Sales by Product Type and Percent of Sales Attributed to Rx-to-OTC Switched Ingredients
    • RX-TO-OTC INDUSTRY
      • Table U.S. Population by Sex, 2005-2050
      • Table United States Population Trend Age 65+ (Thousands)
      • Table World Population by Sex, 2005-2050
      • Table World Population Trend Age 65+ (Thousands)
      • Economic Indicators
        • Table Healthcare Industry Inflation Rates Healthcare Industry Consumer Price Index Comparisons Based on 2009 Data
      • The FDA and Rx-to-OTC Switches
        • Table FDA Human Drugs Outcomes Table, FY 2005 - FY 2009
  • 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
        • Table Incidence of Allergy, Cough, Cold, Sinus Conditions 2010
    • PRODUCT ANALYSIS
      • Switched Products
        • Table Allergy, Cough, Cold, Sinus Product Ingredients Transferred from Rx-to-OTC Status
      • Antihistamines
      • Decongestants
      • Cough Preparations
      • Mast Cell Stabilizers
      • Ophthalmic Preparations
      • Prescription Products with Anticipated OTC Approvals
        • Table Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name, Distributor and Current Activity Ingredient Trade Name Distributor Current Activity
      • Allegra
      • Xyzal
      • Clarinex
      • Astelin Nasal Spray
      • Flonase
      • Nasacort AQ
      • Rhinocort
      • Nasonex
    • MARKET ANALYSIS
      • Market Size and Forecast
        • Table The U.S. Market for Rx-to-OTC Switches Allergy, Cough, Cold, and Sinus Product Revenues 2005-2015
      • Competitive Analysis
        • Table Leading Suppliers' Shares of the U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, and Sinus Products, 2010
  • Analgesics and Other Pain Relievers
    • OVERVIEW
      • Analgesics
      • Nonsteroidal Anti-inflammatory Drugs
      • Topical Pain Relievers and Other Similar Products
    • DESCRIPTION OF CONDITIONS
      • Pain
      • Inflammation
        • Table Incidence of Conditions with Pain and Inflammatory Symptoms 2010
    • PRODUCT ANALYSIS
      • Switched Ingredients
        • Table Analgesics, NSAIDs and Other Ingredients Transferred from Rx-to-OTC Status
      • Antipruritic
      • Internal analgesic/antipyretic
      • Oral anesthetic
      • Prescription Products with Anticipated OTC Approvals
        • Table Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name, Distributor and Current Activity
      • Nonsteroidal anti-inflammatory drugs
      • Voltaren (diclofenac)
      • Diflunisal
      • Etodolac
      • Nabumetone
      • Feldene (piroxicam)
      • Migraine treatments
      • Imitrex
      • Maxalt
      • Zomig
      • Other Migraine Treatments
    • MARKET ANALYSIS
      • Market Size and Forecast
        • Table The U.S. Market for Rx-to-OTC Switches Analgesic Product Revenues 2005-2015
      • Competitive Analysis
        • Table Leading Suppliers' Shares of the U.S. Market for Rx-to-OTC Switches Analgesics 2010
  • 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
        • Table Incidence of Infections by Type, 2010
    • PRODUCT ANALYSIS
      • Switched Ingredients
        • Table Anti-infectives Ingredients Transferred from Rx-to-OTC Status
      • Antifungals
      • Anthelmintics
      • Antimicrobials
      • Pediculicides
      • Prescription Products with Anticipated OTC Approvals
        • Table Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name, Distributor and Current Activity
      • Antivirals
      • Zovirax
      • Valtrex
      • Denavir
      • Influenza Antivirals
      • Antibiotics
      • Antifungals
    • MARKET ANALYSIS
      • Market Size and Forecast
        • Table The U.S. Market for Rx-to-OTC Switches Anti-infective Product Revenues 2005-2015
      • Competitive Analysis
        • Table Leading Suppliers' Shares of The U.S. Market for Rx-to-OTC Switched Anti-infectives 2010
  • Gastrointestinal Drugs
    • OVERVIEW
    • DESCRIPTION OF CONDITIONS
      • Nausea
      • Diarrhea
      • Constipation
      • Heartburn
      • Acid reflux
        • Table Incidence of Gastrointestinal Conditions, 2010
    • PRODUCT ANALYSIS
      • Switched Ingredients
        • Table Gastrointestinal Drug Ingredients Transferred from Rx-to-OTC Status
      • Histamine H2 Inhibitors
      • Proton Pump Inhibitors
      • Antidiarrheals
      • Laxatives
      • Antiemetics
      • Prescription Products with Anticipated OTC Approvals
        • Table Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name, Distributor and Current Activity
      • Proton Pump Inhibitors
      • Nexium
      • Protonix
      • Aciphex
      • Mucosal Protectants
      • Antiemetics
    • MARKET AND COMPETITIVE ANALYSIS
      • Market Size and Forecast
        • Table The U.S. Market for Rx-to-OTC Switches Gastrointestinal Drug Revenues 2005-2015
      • Competitive Analysis
        • Table Leading Suppliers' Shares of the U.S. Market for Rx-to-OTC Switches Gastrointestinal Drugs 2010
  • Smoking Cessation
    • OVERVIEW
    • DESCRIPTION OF CONDITIONS
      • Table Percent of Smokers by Country
      • Lung Cancer and Tobacco Use
        • Table Estimated World Incidence of Lung Cancer by Country, 2010
    • PRODUCT ANALYSIS
      • Switched Ingredients
        • Table Smoking Cessation Product Ingredients Transferred from Rx-to-OTC Status
      • Prescription Products with Anticipated OTC Approvals
        • Table Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name, Distributor and Current Activity
      • Nicotrol
      • Chantix
    • MARKET ANALYSIS
      • Market Size and Forecast
        • Table The U.S. Market for Rx-to-OTC Switches Smoking Cessation Product Revenues 2005-2015
      • Competitive Analysis
        • Table Leading Suppliers' Shares of the U.S. Market for Rx-to-OTC Switches Smoking Cessation Drugs 2010
  • Other Drug Classifications
    • OVERVIEW
      • Contraceptives
      • Dental Rinses and Fluorides
      • Hair Growth Products
      • Rectal Ointments
      • Sleep Aids
      • Weight Management
    • DESCRIPTION OF CONDITIONS
      • Pregnancy
      • Global Birth Rates
        • Table Crude Birth Rate per 1,000 Persons 2000, 2005 and Estimated 2010
      • Abortion Rates
        • Table Number of Abortions in the United States by Year, 1990-2005
      • Contraceptive Use
        • Table Estimated U.S. Contraceptive Use by Method, 2006-2008
      • Dental carries
        • Table Percentage of U.S. Incidence of Untreated Dental Carries by Age Group
      • Hereditary Hair Loss
        • Table Alopecia Trends by World Region
      • Hemorrhoids
      • Sleeplessness
      • Obesity
        • Table Percent of Obese* Population, 2006 (%)
    • CONDITIONS WITH POSSIBLE FUTURE OTC TREATMENTS
      • Acne Vulgaris
      • Elevated Cholesterol
      • Osteoporosis
      • Menopause and Hormone Replacement
      • Erectile Dysfunction
      • Urinary Incontinence/Overactive Bladder
      • Benign Prostate Hypertrophy (BPH)
    • PRODUCT ANALYSIS
      • Switched Ingredients
        • Table Miscellaneous Drug Ingredients Transferred from Rx-to-OTC Status by Trade Name, Distributor, and Date of OTC Approval
      • Contraceptives
      • Dental rinses and fluoride
      • Hair growth
      • Rectal ointments
      • Sleep aids
      • Weight Management
      • Prescription Products with Anticipated OTC Approvals
        • Table Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name, Distributor and Current Activity
      • Acne Treatments
      • Cholesterol-reducing Drugs (antilipidemics)
      • BPH
      • Erectile Dysfunction
      • Hair Loss Treatment
      • Hormone-Replacement Therapies (HRT)
      • Osteoporosis Treatments
      • Overactive Bladder
      • Sleep Aids
    • MARKET ANALYSIS
      • Market Size and Forecast
      • New Product Segments; Post 2015
      • Antilipidemics
      • Osteoporosis and Hormone Replacement
      • Overactive Bladder
      • Sexual Dysfunction
        • Table The U.S. Market for Rx-to-OTC Switches Other Drug Classification Product Revenues 2005-2015
        • Table The U.S. Market for Rx-to-OTC Switches Other Drug Classifications Revenues by Product Type 2005-2015
      • Competitive Analysis
        • Table Leading Suppliers' Shares of the U.S. Market for Rx-to-OTC Switches Other Drug Classifications 2010
  • Total Market Summary
    • OVERVIEW
    • TOTAL MARKET SIZE AND FORECAST
      • Table The U.S. Market for Rx-to-OTC Switches 2005-2015
    • COMPETITIVE ANALYSIS
      • Table Leading Suppliers Significant Segments of Participation within the U.S. Market for Rx-to-OTC Switches, 2010
    • MARKET ANALYSIS
  • Issues and Trends Affecting the Rx-to-OTC Market
    • INTRODUCTION
    • REGULATORY AUTHORITIES
    • ATHIRD CLASS OF DRUG
    • INSURANCE ISSUES AND REIMBURSEMENT FOR OTC DRUGS
      • Health Insurance Trends in the United States
        • Table Health Insurance Trends in the United States 2003-2007
      • Healthcare Flexible Spending Accounts and OTC Medicines
    • IMPACT ON THE CONSUMER
      • Table National Healthcare Expenditures in the United States 1960-2015 (millions)
      • Online Resources for Health Information
      • OTC Availability
        • Table Number of Retail Establishments in the United States and Non- Prescription Medicine Sales, 2007
      • Health Expenditures
        • Table Total Healthcare Expenditures as a Percent of GDP by Country 1990, 2000 and 2006
        • Table Average Annual Expenditures per Consumer Unit for Healthcare 2005-2007
    • PHARMACISTS ROLE
    • IMPACT ON THE PRESCRIPTION DRUG MANUFACTURER
    • STRATEGIES FOR CONTINUED PRODUCT GROWTH
      • Mergers and Acquisitions
      • Sanofi-Aventis and Chattem Consumer
      • Schering-Plough and Merck & Co.
      • Wyeth and Pfizer
      • Reckitt Benckiser and Adams Respiratory Therapeutics
      • Bristol-Myers Squibb and Novartis AG
      • Johnson & Johnson and Pfizer
      • Reckitt Benckiser and Boots Healthcare
      • Bayer and Roche
      • Dual Status Switching
      • Generic Competition
      • Direct-to-Consumer Advertising
    • PATENT EXPIRATION
      • Table U.S. Patent Expirations for Select Prescription Pharmaceuticals
    • LABELING CHANGES
    • INTERNATIONAL TRENDS IN RX-TO-OTC SWITCHES
      • Table Legal Classification Status of Selected Ingredients Worldwide (updated December 2008)
      • Table Individual Ingredients Switched from Rx to OTC by Country, 2009/2010
      • Consumers around the World
      • Prescription vs Over-the-Counter Industry
        • Table Total Pharmaceutical Markets, Prescription vs. Non-Prescription by Country, 2009 (billions USD at the manufacturers' level)
      • World Health, Demographics and Life Expectancy
      • Life Expectancy
        • Table Average Life Expectancy in Years by Country 1980, 2004 and 2009
      • Birth Rates
        • Table Crude Birth Rate per 1,000 Persons 2000, 2005 and Projected 2010
  • Company Profiles
    • INTRODUCTION
    • BAYER HEALTHCARE
    • BOEHRINGER INGELHEIM
    • GLAXOSMITHKLINE
    • JOHNSON &JOHNSON
    • MERCK/ SCHERING-PLOUGH
    • NOVARTIS
    • PFIZER/WYETH
    • PROCTER &GAMBLE
    • RECKITT BENCKISER
    • SANOFI-AVENTIS/CHATTEM
  • Company Directory

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