The Market for Rx-to-OTC Switches, 8th Edition

The Market for Rx-to-OTC Switches, 8th Edition

More than 700 pharmaceutical products have made the switch from Rx to OTC over the past several decades. The U.S. Rx-to-OTC market has grown into a $13.8 billion market. This has mainly been due to factors such as patent expirations, increasing competitiveness with the pharmaceutical environment, the FDA willingness to work with industry, brand re-invention, consumer demand, and cost containment strategies. 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 available only by prescription.

Aging baby boomers, many of which are taking greater interest in their health, have created a growing Rx-to-OTC industry in America. This was reinforced by the pandemic, which presented patients with more selfcare due to lockdowns and mandates. It is anticipated that Rx-to-OTC switch products will continue to grow as interest from both consumers and developers continue to expand. Many of the new products that are on the market may be potential candidates after standing the test of time as a prescription product. Also, the demand for OTC products is not likely to diminish, giving rise to more possibilities in the switched categories. Over one third of American consumers use an OTC medication at least every other day and the numbers are increasing on a regular basis as more products appear on the OTC market.

The current climate of patient-consumer awareness of health issues is continuing to influence the Rx-to-OTC market. Consumers are more prepared to take responsibility for their own health and are willing to purchase medicines over the counter. An increased focus on cost-savings, coupled with the effects of advertising and promotion, result in a higher rate of OTC purchases.

This report, The Market for Rx-to-OTC Switches, 8th Edition, analyses recent switches, products that are near switching. It estimates markets for switched products. Kalorama has examined this market in the past but this report reflects the most up-to-date analysis from Kalorama’s last report in 2017.

As part of its coverage, this report contains:

Issues and Trends Affecting The Rx-To-OTC Switches Market

Leading Participants

Information on the OTC industry

Overview Of The Over-The-Counter Drug Market

International Trends In Rx-To-OTC Switches

Markets by Category

Allergy, Cough, Cold, and Sinus Products: Recent Switches, Market Size, Forecast, Market Share, Brand vs. Switched Brands vs. Generics (Switched Equivalents), Conditions Information, Overview

Analgesics and Other Pain Relievers Recent Switches, Market Size, Forecast, Market Share, Brand vs. Switched Brands vs. Generics (Switched Equivalents), Conditions Information, Overview

Anti-Infectives: Recent Switches, Market Size, Forecast, Market Share, Brand vs. Switched Brands vs. Generics (Switched Equivalents), Conditions Information, Overview

Gastrointestinal Drugs: Recent Switches, Market Size, Forecast, Market Share, Brand vs. Switched Brands vs. Generics (Switched Equivalents), Conditions Information, Overview

Smoking Cessation Products: Recent Switches, Market Size, Forecast, Market Share, Brand vs. Switched Brands vs. Generics (Switched Equivalents), Conditions Information, Overview

Other Drugs: Recent Switches, Overview, Size, Forecast, Market Share, Brand vs. Switched Brands vs. Generics (Switched Equivalents)

Total Market: Market Size, Forecast, Market Share

Company Coverage

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 intense in the OTC market.

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.


  • Executive Summary
    • Overview
    • Scope and Methodology
    • Size and Growth of the Market
      • Table The U.S. Market for Rx-to-OTC Switches, 2021-2026
    • Issues and Trends Affecting the Rx-to-OTC Switches Market
    • Leading Participants
  • The OTC Drug Industry
    • Overview of the Over-the-Counter Drug Market
    • Distribution Channels
      • Table Number of Retail Establishments in the United States and Non-Prescription Medicine Availability, 2017
    • Retail Market Value - OTC Drug Industry
      • Table U.S. OTC Retail Sales, 2000-2021
      • Development of the Rx-to-OTC Drug Market
        • Table Rx-to-OTC Switches Approved by the FDA, 1976–2021
        • Table Number of New Rx-to-OTC Switches in the United States, per Year 1976-2021
        • Table Estimated OTC Sales by Product Category and Percent of Sales Attributed to Rx-to-OTC Switched Ingredients
        • Table Estimated OTC Sales by Product Type and Percent of Sales Attributed to Rx-to-OTC Switched Ingredients (% of total OTC Drug market)
    • U.S. Drug Regulation
      • Expanding Drug Access with Behind the Counter Status
    • Nonprescription Drug Safe Use Regulatory Expansion (NSURE)
      • Physician Uncertainty in Increasing Nonprescription Drug Access
      • Pharmacists Generally Favor Self-Medication
        • Table Typical Pharmacist-Consumer OTC Drug Counseling Session
      • Online Resources for Health Information and Drug Selection
        • Table Internet Uptake has Accelerated During the Pandemic According to the International Telecommunications Union, 2005-2021*
      • Social Media's Influence on Consumer Health Products
    • U.S. Demographics and the Non-Prescription Drug Market
      • Table U.S. Population 2020 and 2030 - > 65 years and < 65 years
    • U.S. Health Spending Indicators
      • Table U.S. Healthcare Industry Inflation Rates: Healthcare Industry Consumer Price Index Comparisons, 2015-2020 Data
    • International Trends in Rx-to-OTC Switches
      • Table Legal Classification Status of Selected Ingredients by Country (Country Code, Alpha-2) (updated through March 2022)
  • Allergy, Cough, Cold, and Sinus Products
    • Overview
      • Antihistamines
      • Decongestants
      • Cough Preparations
      • Ophthalmic Preparations
      • Other Allergy Preparations
    • Description of Conditions
      • Allergic Rhinitis
      • Common Cold
      • Sinusitis
      • Hives
      • Ocular Allergies
        • Table Respiratory Symptoms Impacting Total U.S. Population, Average Annual
    • Product Analysis
      • Switched Products
        • Table Allergy, Cough, Cold, Sinus Product Ingredients Transferred from Rx-to-OTC Status
        • Table Allergy, Cough, Cold, Sinus Product Ingredients Transferred from Rx-to-OTC by Year
    • Recent Switch Activity
      • Astepro
      • Pataday Ophthalmic Spray and Solution
      • Lastacaft
      • Nasonex 24hr Allergy
    • Prescription Products with Anticipated OTC Approvals
      • Table Rx-to-OTC Product Candidates: Allergy, Cough, Cold, Sinus & Asthma
      • Beconase AQ
      • Clarinex
      • Atrovent Nasal Spray
      • Singulair
      • Ventolin (albuterol) and similar products
      • EpiPen (epinephrine) Autoject
      • Atarax, Vistaril (hydroxyzine)
      • Tessalon (benzonatate)
    • Market Analysis
      • Table The U.S. Market for Rx-to-OTC Switches: Allergy/Asthma, Cough, Cold, and Sinus Product Revenues, 2021 and Forecast 2026
      • Table The U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, and Sinus Products, by Percent and Product Type, 2021 and 2026 Estimate
      • Table U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, Sinus, Value Switched Brands vs. Switched Equivalents (Generics), 2010-2021
    • Competitive Analysis
      • Table Leading Suppliers’ Shares for U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, and Sinus Products, 2021
  • Analgesics and Other Pain Relievers
    • Overview
      • Analgesics
      • Nonsteroidal Anti-inflammatory Drugs
      • Topical Pain Relievers and Other Similar Products
    • Description of Conditions
      • Pain
      • Inflammation
        • Table Pain Symptoms Impacting Total U.S. Population, Average Annual
    • Product Analysis
      • Switched Products
        • Table Analgesics, NSAIDs and Other Ingredients Transferred from Rx-to-OTC Status
        • Table Analgesics, NSAIDs and Other Ingredients Transferred from Rx-to-OTC by Year
    • Recent Switch Activity
      • Voltaren Arthritis Pain
    • Prescription Products with Anticipated OTC Approvals
      • Table Rx-to-OTC Product Candidates: Analgesics and Other Pain Relievers
      • Migraine Treatments
    • Market Analysis
      • Table The U.S. Market for Rx-to-OTC Switches: Analgesic Revenues, 2021 and Forecast 2026
      • Table The U.S. Market for Rx-to-OTC Switches: Analgesic Product by Percent and Product Type, 2021 and 2026 Estimate
      • Table U.S. Market for Rx-to-OTC Switches: Analgesics, Value Switched Brands vs. Switched Equivalents (Generics), 2010-2021
    • Competitive Analysis
      • Table Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches, Analgesics, 2021
  • 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 Infection and Fungal Symptoms Impacting Total U.S. Population, Average Annual
    • Product Analysis
      • Switched Products
        • Table Anti-infectives Ingredients Transferred from Rx-to-OTC Status
        • Table Anti-infectives Ingredients Transferred from Rx-to-OTC by Year
    • Recent Switch Activity
      • Sklice
    • Prescription Products with Anticipated OTC Approvals
      • Table Rx-to-OTC Product Candidates: Anti-Infective Products
      • Antivirals
      • Influenza Antivirals
      • Antibiotics
      • Antifungals
    • Market Analysis
      • Table The U.S. Market for Rx-to-OTC Switches, Anti-infective Revenues, 2021 and Forecast 2026
      • Table The U.S. Market for Rx-to-OTC Switches: Anti-infective Product by Percent and Product Type, 2021 and 2026 Estimate
      • Table U.S. Market for Rx-to-OTC Switches: Anti-infective Products, Value Switched Brands vs. Switched Equivalents (Generics), 2010-2021
    • Competitive Analysis
      • Table Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switched Anti-infectives, 2021
  • Gastrointestinal Drugs
    • Overview
      • Histamine H2 Inhibitors
      • Proton Pump Inhibitors
      • Antidiarrheals
      • Laxatives
      • Others
    • Description of Conditions
      • Nausea
      • Diarrhea
      • Constipation
      • Heartburn
      • Acid reflux
        • Table Gastrointestinal/Digestive Symptoms Impacting Total U.S. Population, Average Annual
    • Product Analysis
      • Switched Products
        • Table Gastrointestinal Drug Ingredients Transferred from Rx-to-OTC Status
        • Table Gastrointestinal Drug Ingredients Transferred from Rx-to-OTC by Year
      • Recent Switch Activity
    • Prescription Products with Anticipated OTC Approvals
      • Table Rx-to-OTC Product Candidates: Gastrointestinal Products
      • Mucosal Protectants
      • Antiemetics
    • Market Analysis
      • Table The U.S. Market for Rx-to-OTC Switches, Gastrointestinal Drug Revenues, 2021 and Forecast 2026
      • Table The U.S. Market for Rx-to-OTC Switches: Gastrointestinal Product by Percent and Product Type, 2021 and 2026 Estimate
      • Table U.S. Market for Rx-to-OTC Switches: Gastrointestinal Products, Value Switched Brands vs. Switched Equivalents (Generics), 2010-2021
    • Competitive Analysis
      • Table Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches, Gastrointestinal Drugs, 2021
  • Smoking Cessation Products
    • Overview
    • Description of Conditions
    • Lung Cancer and Tobacco Use
    • Product Analysis
      • Switched Products
        • Table Smoking Cessation Product Ingredients Transferred from Rx-to-OTC Status
    • Prescription Products with Anticipated OTC Approvals
      • Table Rx-to-OTC Product Candidates: Smoking Cessation Products
    • Market Analysis
      • Table The U.S. Market for Rx-to-OTC Switches, Smoking Cessation Product Revenues, 2021 and Forecast 2026
      • Table The U.S. Market for Rx-to-OTC Switches: Smoking Cessation by Percent and Product Type, 2021 and 2026 Estimate
      • Table U.S. Market for Rx-to-OTC Switches: Smoking Cessation, Value Switched Brands vs. Switched Equivalents (Generics), 2010-2021
    • Competitive Analysis
      • Table Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches, Smoking Cessation Drugs, 2021
  • Other Drug Classifications
    • Overview
      • Contraceptives
      • Dental Rinses and Fluorides
      • Hair Growth Products
      • Rectal Ointments
      • Sleep Aids
      • Weight Management
      • Urinary Incontinence Products
    • Description of Conditions
      • Pregnancy
        • Table U.S. Crude Birth Rate per 1,000 Persons 2000, 2005, 2010, 2015 and 2020
      • Dental caries
      • Hereditary Hair Loss
      • Hemorrhoids
      • Sleeplessness
      • Obesity
      • Urinary Incontinence/Overactive Bladder
      • Conditions with Recent or Possible Future OTC Treatments
    • Product Analysis
      • Switched Ingredients
        • Table Miscellaneous Drug Ingredients Transferred from Rx-to-OTC Status by Trade Name, Distributor, and Date of OTC Approval
        • Table Miscellaneous Drug Ingredients Transferred from Rx-to-OTC by Year
      • Contraceptives
      • Dental Rinses and Fluoride
      • Hair Growth
      • Overactive Bladder
      • Rectal Ointments
      • Sleep Aids
      • Weight Management
    • Prescription Products with Anticipated OTC Approvals
      • Table Rx-to-OTC Product Candidates: Various Classification of Products
    • Market Analysis
      • Current Market Segments
      • Potential Rx-to-OTC Switch Products/Categories
    • Competitive Analysis
  • Total Rx-to-OTC Drug Market Summary
    • Overview
    • Total Market Analysis
      • Table The U.S. Market for Rx-to-OTC Switches, 2021-2026
      • Table The U.S. Market for Rx-to-OTC Switches, 2021 and 2026 Forecast
    • Switch Forecast in the United States
      • Table Potential Rx-to-OTC Switches for U.S. Markets
      • Table The U.S. Market for Rx-to-OTC Switches, Distribution of Revenues by Product Category, 2021 and 2026 Forecast
    • Competitive Analysis
      • Table Top 5 Rx-to-OTC Switch Suppliers Significant Segments of Participation, 2021
      • Table Leading Suppliers Market Share in the U.S. Market for Rx-to-OTC Switches, 2021
  • Issues and Trends
    • Naloxone Switch Encouraged by Congress
    • Trends in Consumer Health Divisions
    • Retail Strategies
    • Mergers, Acquisitions and Partnerships
    • Simultaneous Marketing – Prescription vs. OTC
    • Impact on the Prescription Drug Manufacturer
    • Direct-to-Consumer Advertising
    • Patent Expiration
    • Insurance Coverage for OTC Products
  • Profiles for Major Rx-to-OTC Participants
    • Introduction
    • Bayer AG
      • Table Bayer AG Corporate Summary
      • Company Overview
      • Switch Products
    • GlaxoSmithKline
      • Table GlaxoSmithKline Corporate Summary
      • Company Overview
      • Switched Products
    • Johnson & Johnson
      • Table Johnson & Johnson Corporate Summary
      • Company Overview
      • Switched Products
    • Perrigo Company plc
      • Table Perrigo Corporate Summary
      • Company Overview
      • Switched Products
    • Prestige Consumer Healthcare
      • Table Prestige Consumer Healthcare Corporate Summary
      • Company Overview
    • Proctor & Gamble
      • Table Proctor & Gamble Corporate Summary
      • Company Overview
    • Reckitt Benckiser
      • Table Reckitt Benckiser Corporate Summary
      • Company Overview
    • Sanofi/Chattem
      • Table Sanofi Corporate Summary
      • Company Overview

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