Rx to OTC Switches 2009

Rx to OTC Switches 2009

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 Downturn's Impact

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:

• Cholesterol-reducing Drugs


• Osteoporosis Treatments


• Overactive Bladder


• 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 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.

Table of Contents

List of Exhibits

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 Structure

Economic Indicators

The FDA and Rx-to-OTC Switches

Chapter Three

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

Prevalence and Incidence

Product Analysis

Current OTC Switched Products

Antihistamines

Decongestants

Cough Preparations

Mast Cell Stabilizers

Ophthalmic Preparations

Prescription Products with Anticipated OTC Approvals

Allegra

Clarinex

Flonase

Nasacort AQ

Nasonex

Market Analysis

Market Size and Forecast

Competitive Analysis

Chapter Four

Analgesics and Other Pain Relievers

Overview

Analgesics

Nonsteroidal Anti-inflammatory Drugs

Topical Pain Relievers and Other Similar Products

Description of Conditions

Pain

Inflammation

Prevalence and Incidence

Product Analysis

Current OTC Switched Products

Antipruritic

Internal analgesic/antipyretic

Oral anesthetic

Prescription Products with Anticipated OTC Approvals

Nonsteroidal anti-inflammatory drugs

Migraine treatments

Market Analysis

Market Size and Forecast

Competitive Analysis

Chapter Five

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

Prevalence and Incidence

Product Analysis

Current OTC Switched Products

Prescription Products with Anticipated OTC Approvals

Antivirals

Antibiotics

Antifungals

Market Analysis

Market Size and Forecast

Competitive Analysis

Chapter Six

Gastrointestinal Drugs

Overview

Description of Conditions

Nausea

Diarrhea

Constipation

Heartburn

Acid reflux

Prevalence and Incidence

Product Analysis

Current OTC Switched Products

Histamine H2 Inhibitors

Proton Pump Inhibitors

Antidiarrheals

Laxatives

Antiemetics

Prescription Products with Anticipated OTC Approvals

Proton Pump Inhibitors

Mucosal Protectants

Antiemetics

Market and Competitive Analysis

Market Size and Forecast

Competitive Analysis

Chapter Seven

Smoking Cessation

Overview

Description of Conditions

Prevalence and Incidence

Lung Cancer and Tobacco Use

Product Analysis

Current OTC Switched Products

Prescription Products with Anticipated OTC Approvals

Market Analysis

Market Size and Forecast

Competitive Analysis

Chapter Eight

Other Drug Classifications

Overview

Contraceptives

Dental Rinses and Fluorides

Hair Growth Products

Rectal Ointments

Sleep Aids

Weight Management

Description of Conditions

Pregnancy

Dental carries

Hereditary Hair Loss

Hemorrhoids

Sleeplessness

Obesity

Conditions with Possible Future OTC Treatments

Elevated Cholesterol

Osteoporosis

Acne Vulgaris

Menopause and Hormone Replacement

Prevalence and Incidence

Product Analysis

Current OTC Switched Products

Contraceptives

Dental rinses and fluoride

Hair growth

Rectal ointments

Sleep aids

Weight Management

Prescription Products with Anticipated OTC Approvals

Antilipidemics/ Osteoporosis/ Hormone Replacement

Hair Loss Treatment

Acne Treatments

Overactive Bladder

Sexual Dysfunction

Market Analysis

Market Size and Forecast

New Product Segments; Post 2013

Osteoporosis and Hormone Replacement

Overactive Bladder

Sexual Dysfunction

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

Regulatory Authorities

A Third Class of Drug

Insurance Issues and Reimbursement for OTC Drugs

Health Insurance Trends in the United States

Healthcare Flexible Spending Accounts and OTC Medicines

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

Dual Status Switching

Generic Competition

Direct-to-Consumer Advertising

Patent Expiration

Labeling Changes

International Trends in Rx-to-OTC Switches

Prescription vs Over-the-Counter Industry

World Health, Demographics and Life Expectancy

Life Expectancy

Declining Growth of the World Population

Birth Rates

Chapter Eleven: Company Profiles

Introduction

GlaxoSmithKline

Johnson & Johnson

Novartis

Procter & Gamble

Schering-Plough

Wyeth

APPENDIX: Company Directory

Table of Contents

List of Exhibits

Chapter One

Executive Summary

Table 1-1 - The U.S. Market for Rx-to-OTC Switches 2004-2013

Compound Annual Growth Rate

Figure 1-1 - The U.S. Market for Rx-to-OTC Switches, 2004-2013

Chapter Two

Introduction

Table 2-1 - OTC Retail Sales, 1976-2007

Table 2-2 - Rx-to-OTC Switches Approved by the FDA 1976-2007

Figure 2-1 - Number of New Rx-to-OTC Switches per Year 1976-2007

Table 2-3 - Statistics for Selected Rx-to-OTC Switches (United States)

Table 2-4 - Estimated OTC Sales by Product Type and Percent of Sales Attributed to Rx-to-OTC Switched Ingredients

Table 2-5 - U.S. Population by Sex and Selected Age Group, 1997-2017

Figure 2-2 - U.S. Population by Sex, 1997-2017

Figure 2-3 - U.S. Population by Selected Age Group, 1997-2017

Table 2-6 - Healthcare Industry Inflation Rates Healthcare Industry Consumer Price Index Comparisons Based on 2008 Data

Figure 2-4 - Healthcare Industry Inflation Rates Healthcare Industry Consumer Price Index Comparisons Based on 2008 Data

Chapter Three

Allergy, Cough, Cold, and Sinus Products

Table 3-1 - United States Incidence of Allergy, Cough, Cold, Sinus Conditions 2008

Figure 3-1 - United States Incidence of Allergy, Cough, Cold, Sinus Conditions, Superimposed on Total Population, 2008

Table 3-2 - Allergy, Cough, Cold, Sinus Product Ingredients Transferred from Rx-to-OTC Status by Trade Name, Distributor, and Date of OTC Approval

Table 3-3 - Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name, Distributor and Current Activity

Table 3-4 - The U.S. Market for Rx-to-OTC Switches Allergy, Cough, Cold, and Sinus Product Revenues 2004-2008

Compound Annual Growth Rate

Table 3-5 - The Forecasted U.S. Market for Rx-to-OTC Switches Allergy, Cough, Cold, and Sinus Product Revenues 2009-2013

Compound Annual Growth Rate

Figure 3-2 - The U.S. Market for Rx-to-OTC Switches Allergy, Cough, Cold, and Sinus Product Revenues 2004-2013

Figure 3-3 - The U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, and Sinus Products, by Percent and Product Type, 2008

Table 3-6 - Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, and Sinus Products, 2008

Figure 3-4 - Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches: Allergy, Cough, Cold, and Sinus Products, 2008

Chapter Four

Analgesics and Other Pain Relievers

Table 4-1 - United States Incidence of Conditions with Pain and Inflammatory Symptoms 2008

Figure 4-1 - United States Incidence of Conditions with Pain and Inflammatory Symptoms Superimposed on Total Population, 2008

Table 4-2 - Analgesics, NSAIDs and Other Ingredients Transferred from Rx-to-OTC Status by Trade Name, Distributor, and Date of OTC Approval

Table 4-3 - Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name, Distributor and Current Activity

Table 4-4 - The U.S. Market for Rx-to-OTC Switches Analgesic Product Revenues 2004-2008

Compound Annual Growth Rate

Table 4-5 - The Forecasted U.S. Market for Rx-to-OTC Switches Analgesic Product Revenues 2009-2013

Compound Annual Growth Rate

Figure 4-2 - The U.S. Market for Rx-to-OTC Switches Analgesic Product Revenues 2004-2013

Figure 4-3 - The U.S. Market for Rx-to-OTC Switches: Analgesic Product Type, 2008

Table 4-6 - Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Analgesics 2008

Figure 4-4 - Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Analgesics 2008

Chapter Five

Anti-infectives

Table 5-1 - United States Yearly Incidence of Infections, 2008

Figure 5-1 - United States Yearly Incidence of Infections Superimposed on Total Population, 2008

Table 5-2 - Anti-infectives Ingredients Transferred from Rx-to-OTC Status by Trade Name, Distributor, and Date of OTC Approval

Table 5-3 - Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name, Distributor and Current Activity

Table 5-4 - The U.S. Market for Rx-to-OTC Switches Anti-infective Product Revenues 2004-2008

Compound Annual Growth Rate

Table 5-5 - The Forecasted U.S. Market for Rx-to-OTC Switches Anti-infective Product Revenues 2009-2013

Compound Annual Growth Rate

Figure 5-2 - The U.S. Market for Rx-to-OTC Switches Anti-infective Product Revenues 2004-2013

Figure 5-3 - The U.S. Market for Rx-to-OTC Switches: Anti-infective Product Type, 2008

Table 5-6 - Leading Suppliers’ Shares of The U.S. Market for Rx-to-OTC Switched Anti-infectives 2008

Figure 5-4 - Leading Suppliers’ Shares of The U.S. Market for Rx-to-OTC Switched Anti-infectives 2008

Chapter Six

Gastrointestinal Drugs

Table 6-1 - United States Incidence of Gastrointestinal Conditions 2008

Table 6-2 - Gastrointestinal Drug Ingredients Transferred from Rx-to-OTC Status by Trade Name, Distributor, and Date of OTC Approval

Table 6-3 - Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name, Distributor and Current Activity

Table 6-4 - The U.S. Market for Rx-to-OTC Switches Gastrointestinal Drug Revenues 2004-2008

Compound Annual Growth Rate

Table 6-5 - The Forecasted U.S. Market for Rx-to-OTC Switches Gastrointestinal Drug Revenues 2009-2013

Compound Annual Growth Rate

Figure 6-2 - The U.S. Market for Rx-to-OTC Switches Gastrointestinal Drug Revenues 2004-2013

Figure 6-3 - The U.S. Market for Rx-to-OTC Switches: Gastrointestinal Drug by Product Type, 2008

Table 6-6 - Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Gastrointestinal Drugs 2008

Figure 6-4 - Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Gastrointestinal Drugs 2008

Chapter Seven

Smoking Cessation

Table 7-1 - United States Cigarette Usage in Percent by Age Group, 2006

Figure 7-1 - New Lung Cancer Cases and Deaths for 2008 by Gender, United States

Table 7-2 - New Cases of Lung and Bronchus Cancer by State; Deaths from Lung and Bronchus Cancer by State, 2008 Estimates

Table 7-3 - Smoking Cessation Product Ingredients Transferred from Rx-to-OTC Status by Trade Name, Distributor, and Date of OTC Approval

Table 7-4 - Prescription Drugs with Anticipated OTC Approval by Ingredient, Trade Name, Distributor and Current Activity

Table 7-5 - The U.S. Market for Rx-to-OTC Switches Smoking Cessation Product Revenues 2004-2008

Compound Annual Growth Rate

Table 7-5 - The Forecasted U.S. Market for Rx-to-OTC Switches Smoking Cessation Product Revenues 2009-2013

Compound Annual Growth Rate

Figure 7-2 - The U.S. Market for Rx-to-OTC Switches Smoking Cessation Product Revenues 2004-2013

Figure 7-3 - The U.S. Market for Rx-to-OTC Switches: Smoking Cessation Product Type, 2008

Table 7-8 - Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Smoking Cessation Drugs 2008

Figure 7-5 - Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Smoking Cessation Drugs 2008

Chapter Eight

Other Drug Classifications

Table 8-1 - United States Incidence of Miscellaneous Conditions for Which There Are Potential Rx-to-OTC Switches 2008

Table 8-2 - Estimated U.S. Contraceptive Use by Method, Five Year Average 2007/2008

Table 8-3 - Miscellaneous Drug Ingredients Transferred from Rx-to-OTC Status by Trade Name, Distributor, and Date of OTC Approval

Table 8-3 - 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 2004-2008

Compound Annual Growth Rate

Table 8-5 - The Forecasted U.S. Market for Rx-to-OTC Switches Other Drug Classification Product Revenues 2009-2013

Compound Annual Growth Rate

Figure 8-2 - The U.S. Market for Rx-to-OTC Switches Other Drug Classification Product Revenues 2004-2013

Table 8-6 - The U.S. Market for Rx-to-OTC Switches Other Drug Classifications Revenues by Product Type 2004-2013

Compound Annual Growth Rate

Figure 8-3 - The U.S. Market for Rx-to-OTC Switches Other Drug Classifications Revenues by Product Type 2004-2013

Figure 8-4 - The U.S. Market for Rx-to-OTC Switches Other Drug Classifications Distribution of Revenues by Product Type 2008

Table 8-7 - Leading Suppliers’ Shares of the U.S. Market for Rx-to-OTC Switches Other Drug Classifications 2008

Figure 8-5 - Leading Suppliers’ Shares of the U.S. Market for Rx-o-OTC Switches Other Drug Classifications 2008

Chapter Nine

Total Market Summary

Table 9-1 - The U.S. Market for Rx-to-OTC Switches 2004-2013

Compound Annual Growth Rate

Figure 9-1 - The U.S. Market for Rx-to-OTC Switches, 2004-2013

Markets by Segments

Figure 9-2 - The U.S. Market for Rx-to-OTC Switches by Product Category, 2004-2013

Figure 9-3 - The U.S. Market for Rx-to-OTC Switches, Distribution of Revenues by Product Category 2008

Table 9-4 - Leading Suppliers Significant Segments of Participation within the U.S. Market for Rx-to-OTC Switches, 2008

Figure 9-4 - Leading Suppliers Market Share in the U.S. Market for Rx-to-OTC Switches, 2008

Chapter Ten : Issues and Trends Affecting the Rx-to-OTC Market

Table 10-1: Health Insurance Trends in the United States 2003-2006

Table 10-2: National Healthcare Expenditures in the United States 1960-2010

Figure 10-1: Healthcare Spending as a Percent of GDP in the United States

Figure 10-2: Internet Users per 100 Inhabitants, 1994-2006

Table 10-3:Total Healthcare Expenditures as a Percent of GDP by Country 2004 and 2006

Figure 10-3: Total Healthcare Expenditures as a Percent of GDP by Country 2004 and 2006

Table 10-4: Average Annual Expenditures per Consumer Unit for Healthcare 2004-2006

Figure 10-4: Typical Pharmacist-Consumer OTC Drug Counseling Session

Table 10-5: U.S. Patent Expirations for Select Prescription Pharmaceuticals

Table 10-6: Legal Classification Status of Selected Ingredients Worldwide

Table 10-7: Total Pharmaceutical Markets, Prescription vs. Non-Prescription by Region, 2007

Figure 10-5: Total Pharmaceutical Markets, Prescription vs. Non-Prescription by Region, 2007

Table 10-8: Average Life Expectancy in Years by Country 1980 and 2008

Figure 10-6: Average Life Expectancy in Years by Country 1980 and 2008

Table 10-9: World Population 1980 to 2050

Figure 10-7: World Population 1980 to 2050

Table 10-10: Crude Birth Rate per 1,000 Persons 2000, 2005 and Projected 2010

Figure 10-8: Crude Birth Rate per 1,000 Persons 2000, 2005 and Projected 2010