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The Market for Rx to OTC Switches
February 1, 2011
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

2. Anti-Infectives
Gastrointestinal Drugs
Oral Care
Smoking Cessation
Other Drugs, including:
o Dental Rinses and Fluorides
o Hair Growth Products
o Rectal Ointments
o Sleep Aids
o Weight Management
o 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

3. 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
Table of Contents
CHAPTER ONE: EXECUTIVE SUMMARY
Scope and Methodology
Size and Growth of the Market
Issues and Trends Affecting the Rx-to-OTC Switches Market
Leading Competitors
CHAPTER TWO: INTRODUCTION
Overview of the Over-the-Counter Market
Development of the Rx-to-OTC Drug Market
Rx-to-OTC Industry
o Economic Indicators
o The FDA and Rx-to-OTC Switches
CHAPTER THREE: ALLERGY, COUGH, COLD, AND SINUS PRODUCTS
Overview
o Antihistamines
o Decongestants
o Cough Preparations
o Mast Cell Stabilizer
o Ophthalmic Preparations
Description of Conditions
o Allergic Rhinitis
o Common Cold
o Sinusitis
o Hives
o Ocular Allergies
Product Analysis
o Switched Products
o Antihistamines
o Decongestants

4. o Cough Preparations
o Mast Cell Stabilizers
o Ophthalmic Preparations
Prescription Products with Anticipated OTC Approvals
o Allegra
o Xyzal
o Clarinex
o Astelin Nasal Spray
o Flonase
o Nasacort AQ
o Rhinocort
o Nasonex
Market Analysis
o Market Size and Forecast
o Competitive Analysis
CHAPTER FOUR: ANALGESICS AND OTHER PAIN RELIEVERS
Overview
o Analgesics
o Nonsteroidal Anti-inflammatory Drugs
o Topical Pain Relievers and Other Similar Products
Description of Conditions
o Pain
o Inflammation
Product Analysis
o Switched Ingredients
 Antipruritic
 Internal analgesic/antipyretic
 Oral anesthetic
o Prescription Products with Anticipated OTC Approvals
 Nonsteroidal anti-inflammatory drugs
 Voltaren (diclofenac)
 Diflunisal
 Etodolac
 Nabumetone
 Feldene (piroxicam)
 Migraine treatments
 Imitrex
 Maxalt
 Zomig
 Other Migraine Treatments
o Market Analysis
 Market Size and Forecast
 Competitive Analysis

5. CHAPTER FIVE: ANTI-INFECTIVES
Overview
o Antibiotics
o Antifungals
o Antivirals
o Antiparasitics
Description of Conditions
o Vaginal Infections
o Athlete’s Foot
o Jock Itch
o Ringworm
o Dandruff
o Scabies and Pediculosis
o Pinworm
o Fungal Nail Infections
Product Analysis
o Switched Ingredients
 Antifungals
 Anthelmintics
 Antimicrobials
 Pediculicides
o Prescription Products with Anticipated OTC Approvals
 Antivirals
 Zovirax
 Valtrex
 Denavir
 Influenza Antivirals
o Antibiotics
o Antifungals
Market Analysis
o Market Size and Forecast
o Competitive Analysis
CHAPTER SIX: GASTROINTESTINAL DRUGS
Overview
Description of Conditions
o Nausea
o Diarrhea
o Constipation
o Heartburn
o Acid reflux
Product Analysis
o Switched Ingredients
 Histamine H2 Inhibitors

6.  Proton Pump Inhibitors
 Antidiarrheals
 Laxatives
 Antiemetics
o Prescription Products with Anticipated OTC Approvals
 Proton Pump Inhibitors
 Nexium
 Protonix
 Aciphex
o Mucosal Protectants
o Antiemetics
o Market and Competitive Analysis
 Market Size and Fore
 Competitive Analysis
CHAPTER SEVEN: SMOKING CESSATION
Overview
Description of Conditions
o Lung Cancer and Tobacco Use
Product Analysis
o Switched Ingredients
o Prescription Products with Anticipated OTC Approvals
 Nicotrol
 Chantix
Market Analysis
o Market Size and Forecast
o Competitive Analysis
CHAPTER EIGHT: OTHER DRUG CLASSIFICATIONS
Overview
o Contraceptives
o Dental Rinses and Fluorides
o Hair Growth Products
o Rectal Ointments
o Sleep Aids
o Weight Management
Description of Conditions
o Pregnancy
o Global Birth Rates
o Abortion Rates
o Contraceptive Use
o Dental carries
o Hereditary Hair Loss
o Hemorrhoids

7. o Sleeplessness
o Obesity
Conditions with Possible Future OTC Treatments
o Acne Vulgaris
o Elevated Cholesterol
o Osteoporosis
o Menopause and Hormone Replacement
o Erectile Dysfunction
o Urinary Incontinence/Overactive Bladder
o Benign Prostate Hypertrophy (BPH)
Product Analysis
o Switched Ingredients
o Contraceptives
o Dental rinses and fluoride
o Hair growth
o Rectal ointments
o Sleep aids
o Weight Management
o Prescription Products with Anticipated OTC Approvals
o Acne Treatments
o Cholesterol-reducing Drugs (antilipidemics)
o Erectile Dysfunction
o Hair Loss Treatment
o Hormone-Replacement Therapies (HRT)
o Osteoporosis Treatments
o Overactive Bladder
o Sleep Aids
Market Analysis
o Market Size and Forecast
o New Product Segments; Post 2015
o Antilipidemics
o Osteoporosis and Hormone Replacement
o Overactive Bladder
o Sexual Dysfunction
o Competitive Analysis
CHAPTER NINE: TOTAL MARKET SUMMARY
Overview
Total market Size and Forecast
Competitive Analysis
Market Analysis
CHAPTER TEN: ISSUES AND TRENDS AFFECTING THE RX-TO-OTC MARKET
Introduction

8. Regulatory Authorities
A Third Class of Drug
Insurance Issues and Reimbursement for OTC Drugs
o Health Insurance Trends in the United States
o Healthcare Flexible Spending Accounts and OTC Medicines
Impact on the Consumer
o Online Resources for Health Information
o OTC Availability
o Health Expenditures
Pharmacists Role
Impact on the Prescription Drug Manufacturer
Strategies for Continued Product Growth
o 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
o Dual Status Switching
o Generic Competition
o Direct-to-Consumer Advertising
Patent Expiration
Labeling Changes
International Trends in Rx-to-OTC Switches
o Consumers around the World
o Prescription vs Over-the-Counter Industry
o World Health, Demographics and Life Expectancy
o Life Expectancy
o Birth Rates
CHAPTER ELEVEN: COMPANY PROFILES
Introduction
Bayer Healthcare
Boehringer Ingelheim
GlaxoSmithKline
Johnson & Johnson
Merck/ Schering-Plough
Novartis
Pfizer/Wyeth
Procter & Gamble
Reckitt Benckiser
Sanofi-Aventis/Chattem

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