Table of Contents
EXECUTIVE SUMMARY
Overview
Scope and Methodology
Size and Growth of the Market
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
Retail Market ValueOTC Drug Industry
Development of the Rx-to-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
Online Resources for Health Information and Drug Selection
Social Media’s Influence on Consumer Health Products
U.S. Demographics and the Non-Prescription Drug Market
U.S. Population over 65
U.S. Health Spending Indicators
International Trends in Rx-to-OTC Switches
ALLERGY, COUGH, COLD, AND SINUS PRODUCTS
Overview
Antihistamines
Decongestants
Cough Preparations
Ophthalmic Preparations
Other Allergy Preparations
Mast Cell Stabilizers
Intranasal Steroids
Description of Conditions
Allergic Rhinitis
Common Cold
Sinusitis
Hives
Ocular Allergies
Product Analysis
Switched Products
Antihistamines
Decongestants
Cough Preparations
Ophthalmic Preparations
Other Allergy Preparations
Recent Switch Activity
Flonase Allergy
Nasacort Allergy
Prescription Products with Anticipated OTC Approvals
Astelin Nasal Spray
Beconase AQ
Rhinocort
Clarinex
Xyzal
Atrovent Nasal Spray
Nasonex
Singulair
Market Analysis
Market Size and Forecast
Competitive Analysis
ANALGESICS AND OTHER PAIN RELIEVERS
Overview
Analgesics
Nonsteroidal Anti-inflammatory Drugs
Topical Pain Relievers and Other Similar Products
Description of Conditions
Pain
Inflammation
Product Analysis
Switched Products
Antipruritic
Internal analgesic/antipyretic
Oral Anesthetic
Prescription Products with Anticipated OTC Approvals
Nonsteroidal anti-inflammatory drugs
Voltaren (diclofenac)
Diflunisal
Etodolac
Nabumetone
Feldene (piroxicam)
Migraine Treatments
Axert
Imitrex
Maxalt
Zomig
Other Migraine Treatments
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
Fungal Nail Infections
Product Analysis
Switched Products
Antifungals
Anthelmintics
Antimicrobials
Pediculicides
Prescription Products with Anticipated OTC Approvals
Antivirals
Zovirax
Valtrex
Denavir
Famvir
Influenza Antivirals
Antibiotics
Antibiotic Public Health Preparedness
Antifungals
Market Analysis
Market Size and Forecast
Competitive Analysis
GASTROINTESTINAL DRUGS
Overview
Description of Conditions
Nausea
Diarrhea
Constipation
Heartburn
Acid reflux
Product Analysis
Switched Products
Histamine H2 Inhibitors
Proton Pump Inhibitors
Antidiarrheals
Laxatives
Antiemetics
Recent Switch Activity
Prescription Products with Anticipated OTC Approvals
Proton Pump Inhibitors
Protonix
Aciphex
Mucosal Protectants
Antiemetics
Market and Competitive Analysis
Market Size and Forecast
Competitive Analysis
SMOKING CESSATION PRODUCTS
Overview
Description of Conditions
Lung Cancer and Tobacco Use
Product Analysis
Switched Products
Nicotine Chewing Gum
Nicotine Transdermal patch
Nicotine Oral lozenge
Prescription Products with Anticipated OTC Approvals
Nicotrol
Chantix
Market Analysis
Market Size and Forecast
Competitive Analysis
OTHER DRUG CLASSIFICATIONS
Overview
Contraceptives
Dental Rinses and Fluorides
Hair Growth Products
Rectal Ointments
Sleep Aids
Weight Management
Description of Conditions
Pregnancy
Abortion Rates
Contraceptive Use
Dental carries
Hereditary Hair Loss
Hemorrhoids
Sleeplessness
Obesity
Urinary Incontinence/Overactive Bladder
Conditions with Possible Future OTC Treatments
Acne Vulgaris
Benign Prostate Hypertrophy (BPH)
Elevated Cholesterol
Erectile Dysfunction
Menopause and Hormone Replacement
Menorrhagia
Osteoporosis
Product Analysis
Switched Ingredients
Contraceptives
Dental rinses and fluoride
Hair growth
Overactive Bladder
Rectal ointments
Sleep aids
Weight Management
Prescription Products with Anticipated OTC Approvals
Acne Treatments
Cholesterol-reducing Drugs (antilipidemics)
Blood Products
BPH
Erectile Dysfunction
Hair Loss Treatment
Hormone-Replacement Therapies (HRT)
Osteoporosis Treatments
Opioid Overdose Treatment
Overactive Bladder
Sleep Aids
Market Analysis
Current Market Segments
Short-Term New Product Segment Development; 2015-2016
Antilipidemics
Opioid Overdose Treatment
Sexual Dysfunction
New Product Segments; Post 2016
BPH Treatments
Hormone Replacement Therapy and Osteoporosis Treatments
Competitive Analysis
TOTAL RX-TO-OTC DRUG MARKET SUMMARY
Overview
Total market Size and Forecast
Switch Forecast in the United States
Markets by Segments
Competitive Analysis
PROFILES FOR MAJOR RX-TO-OTC PARTICIPANTS
Introduction
Strategies for Continued Product Growth
Mergers and Acquisitions
GlaxoSmithKline and Novartis AG
Bayer AG and Merck & Co.
Prestige Brands and Insight Pharmaceuticals
Perrigo Company Acquisitions
Procter & Gamble and Teva Pharmaceutical Industries
Sanofi and Chattem Consumer
Schering-Plough and Merck & Co.
Wyeth and Pfizer
Reckitt Benckiser and Adams Respiratory Therapeutics
Simultaneous Marketing – Prescription vs OTC
Impact on the Prescription Drug Manufacturer
Direct-to-Consumer Advertising
Patent Expiration
Bayer
Boehringer Ingelheim
GlaxoSmithKline
Johnson & Johnson
Novartis
Perrigo Company
Pfizer
Prestige Brands
Procter & Gamble
Reckitt Benckiser
Sanofi/Chattem
TEVA
COMPANY DIRECTORY
LIST OF EXHIBITS
EXECUTIVE SUMMARY
Table 1-1
The U.S. Market for Rx-to-OTC Switches 2009-2019
Figure 1-1
The U.S. Market for Rx-to-OTC Switches, 2009-2019
THE OTC DRUG INDUSTRY
Table 2-1
Number of Retail Establishments in the United States and Non-Prescription Medicine
Availability, 2012
Table 2-2
OTC Drug Retail Sales*, 2000-2014
Figure 2-1
OTC Retail Sales, 2000-2014
Table 2-3
Rx-to-OTC Switches Approved by the FDA 1976–2014
Table 2-3 (continued)
Rx-to-OTC Switches Approved by the FDA 1976–2014
Figure 2-2
Number of New Rx-to-OTC Switches in the United States, per Year 1976-2014
Table 2-4
Statistics for Selected Rx-to-OTC Switches (United States)
Table 2-5
Estimated OTC Sales by Product Type and Percent of Sales Attributed to Rx-to-OTC
Switched Ingredients
Figure 2-3
Estimated OTC Sales by Product Type and Percent of Sales Attributed to Rx-to-OTC
Switched Ingredients
Figure 2-4
Typical Pharmacist-Consumer OTC Drug Counseling Session
Figure 2-5
Internet Users, Percent of Total Population, 2014
Table 2-6
The U.S. Population, 1980-2050
Figure 2-6
The U.S. Population, 1980-2050
Table 2-7
Percent U.S. Population Over Age 65 by Year, 2000-2050
Figure 2-7
United States Population Trend Age 65+, 2000-2050
Table 2-8
U.S. Healthcare Industry Inflation Rates Healthcare Industry Consumer Price Index
Comparisons 2000-2014 Data
Figure 2-8
U.S. Healthcare Industry Inflation Rates Healthcare Industry Consumer Price Index
Comparisons 2000-2010
Table 2-9
Legal Classification Status of Selected Ingredients Worldwide
Table 2-9 (continued)
Legal Classification Status of Selected Ingredients Worldwide (continued)
Table 2-9 (continued)
Legal Classification Status of Selected Ingredients Worldwide (continued)
Table 2-10
Individual Ingredients Switched from Rx to OTC by Country, 2013/2014
ALLERGY, COUGH, COLD, AND SINUS PRODUCTS
Figure 3-1
U.S. Incidence of Allergy, Cough, Cold, Sinus Conditions, Superimposed on Total
Population, 2014 Estimate
Table 3-1
Allergy, Cough, Cold, Sinus Product Ingredients Transferred from Rx-to-OTC Status. 54
Table 3-1 (continued)
Allergy, Cough, Cold, Sinus Product Ingredients Transferred from Rx-to-OTC Status. 55
Figure 3-2
Allergy, Cough, Cold, Sinus Product Ingredients Transferred from Rx-to-OTC by Year56
Table 3-2
Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name,
Distributor and Current Activity
Table 3-3
The U.S. Market for Rx-to-OTC Switches Allergy, Cough, Cold, and Sinus Product
Revenues 2009-2019
Figure 3-3
The U.S. Market for Rx-to-OTC Switches Allergy, Cough, Cold, and Sinus Product
Revenues 2009-2019
Figure 3-4
The U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, and Sinus Products,
by Percent and Product Type, 2014
Figure 3-5
U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, Sinus, Value Switched
Brands vs. Switched Equivalents (Generics), 2009-2019
Table 3-4
Leading Suppliers’ Shares for U.S. Market for Rx-to-OTC Switches: Allergy, Cough,
Cold, and Sinus Products, 2014
Figure 3-6
Leading Suppliers’ Shares for U.S. Market for Rx-to-OTC Switches: Allergy, Cough,
Cold, and Sinus Products, 2014
ANALGESICS AND OTHER PAIN RELIEVERS
Figure 4-1
U.S. Incidence of Conditions with Pain and Inflammatory Symptoms Superimposed on
Total Population, 2014 Estimates
Table 4-1
Analgesics, NSAIDs and Other Ingredients Transferred from Rx-to-OTC Status
Figure 4-2
Analgesics, NSAIDs and Other Ingredients Transferred from Rx-to-OTC by Year
Table 4-2
Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name,
Distributor and Current Activity
Table 4-3
The U.S. Market for Rx-to-OTC Switches Analgesic Product Revenues 2009-2019
Figure 4-3
The U.S. Market for Rx-to-OTC Switches Analgesic Product Revenues 2009-2019
Figure 4-4
The U.S. Market for Rx-to-OTC Switches: Analgesic Product Percent by Type, 2014 93
Table 4-4
Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Analgesics
2014
Figure 4-6
Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Analgesics
2014
ANTI-INFECTIVES
Figure 5-1
U.S. Incidence of Infections by Type Superimposed on Total Population, 2014
Estimates
Table 5-1
Anti-infectives Ingredients Transferred from Rx-to-OTC Status
Figure 5-2
Anti-infectives Ingredients Transferred from Rx-to-OTC by Year
Table 5-2
Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name,
Distributor and Current Activity
Table 5-3
The U.S. Market for Rx-to-OTC Switches Anti-infective Product Revenues 2009-2019116
Figure 5-3
The U.S. Market for Rx-to-OTC Switches Anti-infective Product Revenues 2009-2019117
Figure 5-4
The U.S. Market for Rx-to-OTC Switches: Anti-infective Product Type, 2014
Table 5-4
Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switched Anti-infectives
2014
Figure 5-6
Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switched Anti-infectives
2014
GASTROINTESTINAL DRUGS
Figure 6-1
U.S. Incidence of Gastrointestinal Conditions and Disorders Superimposed on Total
Population, 2014 Estimate
Table 6-1
Gastrointestinal Drug Ingredients Transferred from Rx-to-OTC Status
Figure 6-2
Gastrointestinal Drug Ingredients Transferred from Rx-to-OTC by Year
Table 6-2
Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name,
Distributor and Current Activity
Table 6-3
The U.S. Market for Rx-to-OTC Switches Gastrointestinal Drug Revenues 2009-2019139
Figure 6-3
The U.S. Market for Rx-to-OTC Switches Gastrointestinal Drug Revenues 2009-2019140
Figure 6-4
The U.S. Market for Rx-to-OTC Switches: Gastrointestinal Drug by Product Type, 2014141
Table 6-4
Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Gastrointestinal
Drugs 2014
Figure 6-6
Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Gastrointestinal
Drugs 2014
SMOKING CESSATION PRODUCTS
Table 7-1
Smoking Cessation Product Ingredients Transferred from Rx-to-OTC Status
Figure 7-1
Smoking Cessation Product Ingredients Transferred from Rx-to-OTC by Year
Table 7-2
Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name,
Distributor and Current Activity
Table 7-3
The U.S. Market for Rx-to-OTC Switches Smoking Cessation Product Revenues 2009-
2019
Figure 7-2
The U.S. Market for Rx-to-OTC Switches Smoking Cessation Product Revenues 2009-
2019
Figure 7-3
The U.S. Market for Rx-to-OTC Switches: Smoking Cessation Product Type, 2014 . 160
Table 7-4
Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Smoking
Cessation Drugs 2014
Figure 7-5
Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Smoking
Cessation Drugs 2014
OTHER DRUG CLASSIFICATIONS
Table 8-1
U.S. Crude Birth Rate per 1,000 Persons 2000, 2005, 2010 and Projected 2015 and 2020170
Table 8-2
Miscellaneous Drug Ingredients Transferred from Rx-to-OTC Status by Trade Name,
Distributor, and Date of OTC Approval
Figure 8-1
Miscellaneous Drug Ingredients Transferred from Rx-to-OTC by Year
Table 8-3
Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name,
Distributor and Current Activity
Table 8-3 (continued)
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 Other Drug Classification Product Revenues
2009-2019
Figure 8-2
The U.S. Market for Rx-to-OTC Switches Other Drug Classification Product Revenues
2009-2019
Figure 8-3
The U.S. Market for Rx-to-OTC Switches Other Drug Classifications Distribution of
Revenues by Product Type 2014
Figure 8-4
The U.S. Market for Rx-to-OTC Switches Other Drug Classifications Distribution of
Revenues by Product Type 2019
TOTAL RX-TO-OTC DRUG MARKET SUMMARY
Table 9-1
The U.S. Market for Rx-to-OTC Switches 2009-2019
Figure 9-1
The U.S. Market for Rx-to-OTC Switches, 2009-2019
Table 9-2
Potential Rx-to-OTC Switches, 2015-2019
Table 9-2 (continued)
Potential Rx-to-OTC Switches, 2015-2019
Table 9-2 (continued)
Potential Rx-to-OTC Switches, 2015-2019
Table 9-3
The U.S. Market for Rx-to-OTC Switches 2009-2019
Figure 9-2
The U.S. Market for Rx-to-OTC Switches by Product Category, 2009-2019
Figure 9-3
The U.S. Market for Rx-to-OTC Switches, Distribution of Revenues by Product
Category 2014
Figure 9-4
The U.S. Market for Rx-to-OTC Switches, Distribution of Revenues by Product
Category 2019
Table 9-4
Leading Suppliers Significant Segments of Participation within the U.S. Market for Rxto-
OTC Switches, 2014
Figure 9-5
Leading Suppliers Market Share in the U.S. Market for Rx-to-OTC Switches, 2014 .. 229
PROFILES FOR MAJOR RX-TO-OTC PARTICIPANTS
COMPANY DIRECTORY
