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The U.S. Market for Rx to OTC Switches, 6th Edition


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

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, once only available by prescription.   This report represents the six time that Kalorama Information has analyzed the market for drugs with switched ingredients in detail.  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.

The U.S. Market for Rx-to-OTC Switches focuses on several treatment segments in which Rx-to-OTC switches are available. These include:

  • Allergy, Cough, Cold, and Sinus Products
  • Analgesics, NSAIDs, and Pain Treatments
  • Anti-Infectives
  • Gastrointestinal Drugs
  • Hair Loss Products
  • Hormones
  • Oral Care
  • Rectal Ointments
  • Sleep-aids
  • Smoking Cessation
  • Weight Loss
In addition to the areas with switches in place, Kalorama Information has identified other areas which may be open to Rx-to-OTC switches in the future. These include:
  • Blood Products
  • BPH Treatments
  • Cholesterol-reducing Drugs
  • Hormone Replacement Therapies
  • Migraine Treatments
  • Osteoporosis Treatments
  • Overactive Bladder
  • Sexual Dysfunction/ Erectile 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 detail 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.

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 allergy treatments, cholesterol-reducing drugs, urinary disorders treatments and hormones treatments are expected to make the most impact.

There are several companies that compete heavily in this market and use the Rx-to-OTC switch as a major part of their life-cycle management arsenal. Companies involved in the Rx-to-OTC switched market include brand, generic, and private label manufacturers. Competition will likely continue to be moderate in the OTC market, especially with the patent expiration of key products nearing. Consolidation remains a major factor in this market. Most major players have made a significant acquisition or formed a strategic alliance to increase revenues and drive growth. Product innovation, line extensions and strong promotional support are a few of the top strategies for growth in this industry.

Leading competitors offering key brand products are provided in this report. These companies include:
  • Bayer Healthcare
  • Boehringer Ingelheim
  • GlaxoSmithKline
  • Insight Pharmaceuticals
  • Johnson & Johnson
  • Merck
  • Novartis
  • Pfizer
  • Prestige Brands
  • Procter & Gamble
  • Reckitt Benckiser
  • Sanofi (Chattem)
  • TEVA
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 providers, company representatives 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, business development managers, division managers, and product representatives.

All market data pertains to the U.S. market at the manufacturers’ level. The base year for data was 2012. Historical data are provided for 2007 through 2011, with forecast data provided for 2013 through 2017. Compound annual growth rates (CAGRs) are provided for the 2007-2012, 2012-2017 and 2007-2017 periods for each industry segment covered."


  • Executive Summary
    • SCOPE AND METHODOLOGY
    • SIZE AND GROWTH OF THE MARKET
      • Table The U.S. Market for Rx-to-OTC Switches 2007-2017
    • ISSUES AND TRENDS AFFECTING THE RX-TO-OTC SWITCHES MARKET
    • LEADING COMPETITORS
  • Introduction
    • OVERVIEW OF THE OVER-THE-COUNTER MARKET
      • Table OTC Retail Sales, 1976-2011
    • DEVELOPMENT OF THE RX-TO-OTC DRUG MARKET
      • Table Rx-to-OTC Switches Approved by the FDA 1976-2012
      • 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 Percent U.S. Population Over Age 65 by Year
      • Economic Indicators
        • Table Healthcare Industry Inflation Rates Healthcare Industry Consumer Price Index Comparisons 2000-2010
      • The FDA and Rx-to-OTC Switches
        • Table FDA Human Drugs Outcomes Table, FY 2005 - FY 2012
  • 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 - 2012 Estimate
    • PRODUCT ANALYSIS
      • Switched Products
        • Table Allergy, Cough, Cold, Sinus 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
    • MARKET ANALYSIS
      • Market Size and Forecast
        • Table The U.S. Market for Rx-to-OTC Switches Allergy, Cough, Cold, and Sinus Product Revenues 2007-2017
      • Competitive Analysis
        • Table Leading Suppliers' Shares of the U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, and Sinus Products, 2012
  • 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 2010-2012 Estimates
    • PRODUCT ANALYSIS
      • Switched Ingredients
        • Table Analgesics, NSAIDs and Other 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
    • MARKET ANALYSIS
      • Market Size and Forecast
        • Table The U.S. Market for Rx-to-OTC Switches Analgesic Product Revenues 2007-2017
      • Competitive Analysis
        • Table Leading Suppliers' Shares of the U.S. Market for Rx-to-OTC Switches Analgesics 2012
  • 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 - 2012 Estimates
    • PRODUCT ANALYSIS
      • Switched Ingredients
        • Table Anti-infectives 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
    • MARKET ANALYSIS
      • Market Size and Forecast
        • Table The U.S. Market for Rx-to-OTC Switches Anti-infective Product Revenues 2007-2017
      • Competitive Analysis
        • Table Leading Suppliers' Shares of the U.S. Market for Rx-to-OTC Switched Anti-infectives 2012
  • Gastrointestinal Drugs
    • OVERVIEW
    • DESCRIPTION OF CONDITIONS
      • Nausea
      • Diarrhea
      • Constipation
      • Heartburn
      • Acid reflux
        • Table Incidence of Gastrointestinal Conditions, 2010 - 2012 Estimates
    • PRODUCT ANALYSIS
      • Switched Ingredients
        • Table Gastrointestinal Drug 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
    • MARKET AND COMPETITIVE ANALYSIS
      • Market Size and Forecast
        • Table The U.S. Market for Rx-to-OTC Switches Gastrointestinal Drug Revenues 2007-2017
      • Competitive Analysis
        • Table Leading Suppliers' Shares of the U.S. Market for Rx-to-OTC Switches Gastrointestinal Drugs 2012
  • Smoking Cessation Products
    • 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
    • MARKET ANALYSIS
      • Market Size and Forecast
        • Table The U.S. Market for Rx-to-OTC Switches Smoking Cessation Product Revenues 2007-2017
      • Competitive Analysis
        • Table Leading Suppliers' Shares of the U.S. Market for Rx-to-OTC Switches Smoking Cessation Drugs 2012
  • Other Drug Classifications
    • OVERVIEW
      • Contraceptives
      • Dental Rinses and Fluorides
      • Hair Growth Products
      • Rectal Ointments
      • Sleep Aids
      • Weight Management
    • DESCRIPTION OF CONDITIONS
      • Pregnancy
        • Table Crude Birth Rate per 1,000 Persons 2000, 2005, 2010 and Projected 2012 and 2020
        • Table Number of Abortions in the United States by Year, 1990-2010
        • Table Estimated U.S. Contraceptive Use by Method, Average 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, 2008 (%)
    • CONDITIONS WITH POSSIBLE FUTURE OTC TREATMENTS
      • Acne Vulgaris
      • Benign Prostate Hypertrophy (BPH)
      • Elevated Cholesterol
      • Erectile Dysfunction
      • Menopause and Hormone Replacement
      • Menorrhagia
      • Osteoporosis
      • Urinary Incontinence/Overactive Bladder
    • PRODUCT ANALYSIS
      • Switched Ingredients
        • Table Miscellaneous Drug Ingredients Transferred from Rx-to-OTC Status by Trade Name, Distributor, and Date of OTC Approval
      • Prescription Products with Anticipated OTC Approvals
        • Table Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name, Distributor and Current Activity
    • MARKET ANALYSIS
      • Current Market Segments
      • Short-Term New Product Segment Development; 2013-2017
      • New Product Segments; Post 2017
        • Table The U.S. Market for Rx-to-OTC Switches Other Drug Classification Product Revenues 2007-2017
      • Competitive Analysis
  • Total Market Summary
    • OVERVIEW
    • TOTAL MARKET SIZE AND FORECAST
      • Table The U.S. Market for Rx-to-OTC Switches 2007-2017
      • Table Potential Rx-to-OTC Switches, 2013-2017
    • COMPETITIVE ANALYSIS
      • Table Leading Suppliers Significant Segments of Participation within the U.S. Market for Rx-to-OTC Switches, 2012
  • Issues and Trends Affecting the Rx-to-OTC Market
    • INTRODUCTION
    • REGULATORY AUTHORITIES
    • ADDITIONAL DRUG ACCESS
    • USING TECHNOLOGY OR PHARMACIES FOR NONPRESCRIPTION DRUG ACCESS
      • Physicians and Increasing Nonprescription Drug Access
    • IMPACT ON THE CONSUMER
      • Table National Healthcare Expenditures in the United States 1960-2015 (millions)
      • Table Average Annual Expenditures per Consumer Unit for Healthcare 2005-2009
      • Table Number of Retail Establishments in the United States and Non-Prescription Medicine Availability, 2010
    • INSURANCE ISSUES AND REIMBURSEMENT FOR OTC DRUGS
      • Health Insurance Trends in the United States
        • Table Health Insurance Trends in the United States 2007 and 2011
      • Healthcare Flexible Spending Accounts, Health Savings Accounts and OTC Medicines
    • CHANGING THE PHARMACIST'S ROLE
    • IMPACT ON THE PRESCRIPTION DRUG MANUFACTURER
    • STRATEGIES FOR CONTINUED PRODUCT GROWTH
      • Mergers and Acquisitions
    • STRATEGIES IN SWITCHING
      • Dual Status Switching
      • Generic Competition
      • Direct-to-Consumer Advertising
    • PATENT EXPIRATION
      • Table U.S. Patent Expirations for Select Prescription Pharmaceuticals
    • INTERNATIONAL TRENDS IN RX-TO-OTC SWITCHES
      • Table Legal Classification Status of Selected Ingredients Worldwide (updated through October 2011)
      • Table Individual Ingredients Switched from Rx to OTC by Country, 2010/2011
      • Consumers around the World
      • Streamlined Access to OTC Drug Products in Canada
      • Prescription vs Over-the-Counter Industry
        • Table Total Pharmaceutical Markets, Prescription vs. Non-Prescription by Country, 2011 (billions USD at the manufacturers' level)
      • World Health, Demographics and Life Expectancy
        • Table Average Life Expectancy in Years by Country 1980, 2004 and 2011
      • Birth Rates
        • Table Crude Birth Rate per 1,000 Persons 2000, 2005 and Projected 2012 and 2020
  • Company Profiles
    • INTRODUCTION
    • BAYER HEALTHCARE
    • BOEHRINGER INGELHEIM
    • GLAXOSMITHKLINE
    • INSIGHT PHARMACEUTICALS
    • JOHNSON & JOHNSON
    • MERCK & CO.
    • NOVARTIS
    • PFIZER
    • PRESTIGE BRANDS
    • PROCTER & GAMBLE
    • RECKITT BENCKISER
    • SANOFI/CHATTEM
    • TEVA
  • Company Directory

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