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Healthcare
In-Depth Report Series




          Rx-to-OTC Switch Forecasts USA
          2010

          9th Edition

          Published April 2010
          Base Year: 2009

                                        This comprehensive report provides subscribers with objective,
                                        independent forecasts of future Rx-to-OTC switches and their
                                        expected impacts on the OTC market. This analysis provides
                                        forecasts of future switches in existing OTC categories and
                                        projections for new OTC categories. The study provides an analysis
                                        of:


                                            Comparative analysis of prescription and over-the-counter
                                            markets
                                            Regulatory issues
                                            Safety/efficacy issues
                                            Potential OTC indications and claims
                                            Likelihood of switch and expected timing
                                            OTC market potential and sales forecasts
                                            Expected competitive response including branded and private-
                                            label strategies




  www.KlineGroup.com
  Report #Y406C | © 2010 Kline & Company, Inc.
Rx-to-OTC Switch Forecasts USA 2010

  Report Scope
  Over the past three years there have been significant OTC brands brought to market through Rx-to-OTC switches
  including Miralax (Schering-Plough) laxative, Zyrtec (Johnson & Johnson) allergy medication, Alli (GlaxoSmithKline)
  weight loss medication, and Plan B (Teva Pharmaceuticals) emergency contraceptive. Each of these new products
  has served to expand their respective categories and help offset impacts of economic recession.


  Additional switches are expected over the next few years that are likely to have significant impacts on the industry.
  Rx-to-OTC-Switch Forecasts USA 2010 presents a detailed analysis of future Rx-to-OTC switches in the United
  States. The report identifies the likelihood of future switches by profiling a total of 36 specific drugs in seven
  therapeutic classes and addressing switch issues in each therapeutic class and for each drug.




  Key Benefits
  For marketers of OTC drugs, Rx-to-OTC Switch Forecasts USA 2010 examines key issues and implications that an
  Rx-to-OTC switch could have on the existing OTC business and identifies ways to successfully compete. For existing
  OTC brands, switches can erode sales and market positions. Accurately predicting Rx-to-OTC switches and
  assessing their impact is crucial for maximizing business opportunities, minimizing threats, and successfully
  constructing long-term strategic plans.


  Specifically, the report provides subscribers with the following key deliverables:


      Up-to-date primary research on switches conducted with knowledgeable industry participants
      An objective perspective on future switches
      An understanding of the implications of future switches for existing OTC markets and brands
      Forecasts of major switches, including timing, brand sales, and both prescription and over-the-counter market
      sales


  Forecasts in this report are generated with Kline's FutureView Scenario Forecasting Model. With the enhanced
  forecasts, subscribers can see how adjustments in the assumptions behind the forecasts can bring about different
  results.




 www.KlineGroup.com                                                         Report #Y406C | © 2010 Kline & Company, Inc.
Rx-to-OTC Switch Forecasts USA 2010

 Report Contents
 1.   INTRODUCTION

 2.   EXECUTIVE SUMMARY

 3.   FUTURE SWITCH FORECASTS

      For each therapeutic class listed in Table 1, the study
                                                                                                          Table 1
      examines the following:
                                                                                         Therapeutic Classes and Brands Examined

          Comparative analysis of Rx and OTC markets                                     Class                           Brand(s)
          Demographics of target population
          Incidence and prevalence of the disease/condition                Allergy                         Allegra, Astelin/Astepro, Clarinex,
          Patent expirations in the class and generic threats                                              Flonase, Omnaris, Xyxal
          Strategic considerations for Rx-to-OTC switch                    Benign prostatic hyperplasia    Cardura, Flomax, Hytrin
          Regulatory considerations
                                                                           Cholesterol                     Crestor, Lescol, Lipitor, Mevacor,
          Safety issues/indications appropriate for OTC use
                                                                                                           Pravachol, Pravigard PAC, Vytorin,
          Timing                                                                                           Zetia, Zocor
          Pricing considerations
                                                                           Digestives                      Prevacid 24HR, Zegerid, Protonix,
          Marketing issues
                                                                                                           Aciphex, Nexium, Carafate
          Switch forecast
          Brand(s) that are likely to switch                               Incontinence                    Detrol, Ditropan, Enablex, Vesicare,
          Implications for Rx and OTC markets                                                              Oxytrol
          Expected future OTC sales                                        Migraine                        Imitrex, Relpax, Treximet
          Forecasts of competitive responses including both branded
                                                                           Sleeping aids                   Ambien, Lunesta, Restoril, Rozerem
          and private-label OTCs

      For each of the brands listed in Table 1, the study examines
      the following:


          Patent status
          Current Rx sales and market share
          Regulatory issues
          Rx-to-OTC-switch/OTC expertise of the marketer
          OTC formulation/dosage considerations
          Potential OTC indications and claims
          Safety/efficacy issues
          Brand name awareness
          Recent Rx direct-to-consumer advertising spending
          Likelihood of switch and expected timing
          OTC market potential and sales forecasts by brand
          Pricing strategy
          Managed care/Medicare influence

 4.   FUTUREVIEW FORECASTING MODEL

      Forecasts by therapeutic class and brand in this report are gener-
      ated with Kline's FutureView Scenario Forecasting Model, which
      provides Kline's forecasts for future switches and allows users to
      change assumptions to see how various scenarios may impact
      future switch sales. Subscribers can see how adjustments in the
      assumptions behind the forecasts can bring about different out-
      comes.




  www.KlineGroup.com                                                                       Report #Y406C | © 2010 Kline & Company, Inc.
Rx-to-OTC Switch Forecasts USA 2010

  Methodology
  As the leading consultancy on Rx-to-OTC switches, Kline has developed a program based heavily on primary
  research (field and phone interviews) that has proven to be most effective and reliable in preparing switch forecasts.
  Rx-to-OTC-Switch Forecasts USA 2010 leverages our contacts in the industry and employs the use of primary
  research to capture insights and information available from a wide range of industry experts and opinion leaders.
  The field and phone interviews were conducted by Kline's professional staff with executives from the following
  functional areas: brand management, business development, marketing, R&D, scientific affairs, strategic planning,
  healthcare industry associations, managed care organizations, third party payers, and retailers.

  In addition to primary research, the study draws upon relevant secondary data, including regulatory information
  obtained from the FDA and patent searches. In forecasting Rx-to-OTC switches, a variety of factors are at play in
  each market that can affect the timing of switches. Competitive pressures, regulatory hurdles, and patent
  expirations each play significant roles in switch timing. Therefore, each brand is analyzed on a case-by-case basis,
  and the forecast time horizon may differ for each. Forecasts extend at least three years post-switch in each case.

  Forecasts in this report are generated with Kline's FutureView Scenario Forecasting Model. With the enhanced
  forecasts, subscribers can see how adjustments in the assumptions behind the forecasts can bring about different
  outcomes.



  Kline Credentials
  Kline is a worldwide consulting and research firm dedicated to providing the kind of insight and knowledge that
  helps companies find a clear path to success. The firm has served
                                                                     Recently published or in-progress research for the
  the management consulting and market research needs of organi-     Healthcare industry includes:
  zations in the chemicals, materials, energy, life sciences, and
                                                                         Nonprescription Drugs USA
  consumer products industries for 50 years.
                                                                             OTC Innovations USA 1999-2009: Analysis of
                                                                             Factors for Success
  Kline's research and consulting services extend across the entire          Impact of Recessions on the U.S. OTC Market
  healthcare industry value chain. Our solutions have helped clients         Personal Care: U.S. Competitor Cost Structures
  develop better ways to create and profit from new business
                                                                             U.S. Retailers' Perceptions of OTC Drug
  opportunities, respond to competitive and economic threats,                Marketers
  improve productivity, achieve sustainable growth, and optimize             Rx-to-OTC Switch Strategies USA
  performance. Kline provides clients with facts, forecasts, and             U.S. Consumers' Perceptions of OTC Drugs
  recommendations based solidly on the realities of the market.              Nonprescription Drugs Canada
                                                                             OTC Drugs: U.S. Competitive Costs Structures
  Our market research reports and services are designed to provide          2010
  subscribers with a deeper understanding of their markets, an
  outlook for their business, and accurate information about their competitors. Our clients tell us they often use
  Kline's market research to validate their own internal analysis, and many clients rely on Kline reports as their most
  critical source of information.

  For more information about this study or Kline's other services, e-mail us at sales@klinegroup.com, visit our website
  at www.KlineGroup.com, or contact us at any of our regional offices listed below.

  North America       Latin America        Europe              Japan                Asia                     India
  +1-973-435-6262     +55-11-3079-0792     +32-2-770-4740      +81-3-3242-6277      +86-21-6876-8600         +91-124-4546-100


 www.KlineGroup.com                                                         Report #Y406C | © 2010 Kline & Company, Inc.

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Rx to-OTC Switch Forecasts 2010 US - Brochure

  • 1. Healthcare In-Depth Report Series Rx-to-OTC Switch Forecasts USA 2010 9th Edition Published April 2010 Base Year: 2009 This comprehensive report provides subscribers with objective, independent forecasts of future Rx-to-OTC switches and their expected impacts on the OTC market. This analysis provides forecasts of future switches in existing OTC categories and projections for new OTC categories. The study provides an analysis of: Comparative analysis of prescription and over-the-counter markets Regulatory issues Safety/efficacy issues Potential OTC indications and claims Likelihood of switch and expected timing OTC market potential and sales forecasts Expected competitive response including branded and private- label strategies www.KlineGroup.com Report #Y406C | © 2010 Kline & Company, Inc.
  • 2. Rx-to-OTC Switch Forecasts USA 2010 Report Scope Over the past three years there have been significant OTC brands brought to market through Rx-to-OTC switches including Miralax (Schering-Plough) laxative, Zyrtec (Johnson & Johnson) allergy medication, Alli (GlaxoSmithKline) weight loss medication, and Plan B (Teva Pharmaceuticals) emergency contraceptive. Each of these new products has served to expand their respective categories and help offset impacts of economic recession. Additional switches are expected over the next few years that are likely to have significant impacts on the industry. Rx-to-OTC-Switch Forecasts USA 2010 presents a detailed analysis of future Rx-to-OTC switches in the United States. The report identifies the likelihood of future switches by profiling a total of 36 specific drugs in seven therapeutic classes and addressing switch issues in each therapeutic class and for each drug. Key Benefits For marketers of OTC drugs, Rx-to-OTC Switch Forecasts USA 2010 examines key issues and implications that an Rx-to-OTC switch could have on the existing OTC business and identifies ways to successfully compete. For existing OTC brands, switches can erode sales and market positions. Accurately predicting Rx-to-OTC switches and assessing their impact is crucial for maximizing business opportunities, minimizing threats, and successfully constructing long-term strategic plans. Specifically, the report provides subscribers with the following key deliverables: Up-to-date primary research on switches conducted with knowledgeable industry participants An objective perspective on future switches An understanding of the implications of future switches for existing OTC markets and brands Forecasts of major switches, including timing, brand sales, and both prescription and over-the-counter market sales Forecasts in this report are generated with Kline's FutureView Scenario Forecasting Model. With the enhanced forecasts, subscribers can see how adjustments in the assumptions behind the forecasts can bring about different results. www.KlineGroup.com Report #Y406C | © 2010 Kline & Company, Inc.
  • 3. Rx-to-OTC Switch Forecasts USA 2010 Report Contents 1. INTRODUCTION 2. EXECUTIVE SUMMARY 3. FUTURE SWITCH FORECASTS For each therapeutic class listed in Table 1, the study Table 1 examines the following: Therapeutic Classes and Brands Examined Comparative analysis of Rx and OTC markets Class Brand(s) Demographics of target population Incidence and prevalence of the disease/condition Allergy Allegra, Astelin/Astepro, Clarinex, Patent expirations in the class and generic threats Flonase, Omnaris, Xyxal Strategic considerations for Rx-to-OTC switch Benign prostatic hyperplasia Cardura, Flomax, Hytrin Regulatory considerations Cholesterol Crestor, Lescol, Lipitor, Mevacor, Safety issues/indications appropriate for OTC use Pravachol, Pravigard PAC, Vytorin, Timing Zetia, Zocor Pricing considerations Digestives Prevacid 24HR, Zegerid, Protonix, Marketing issues Aciphex, Nexium, Carafate Switch forecast Brand(s) that are likely to switch Incontinence Detrol, Ditropan, Enablex, Vesicare, Implications for Rx and OTC markets Oxytrol Expected future OTC sales Migraine Imitrex, Relpax, Treximet Forecasts of competitive responses including both branded Sleeping aids Ambien, Lunesta, Restoril, Rozerem and private-label OTCs For each of the brands listed in Table 1, the study examines the following: Patent status Current Rx sales and market share Regulatory issues Rx-to-OTC-switch/OTC expertise of the marketer OTC formulation/dosage considerations Potential OTC indications and claims Safety/efficacy issues Brand name awareness Recent Rx direct-to-consumer advertising spending Likelihood of switch and expected timing OTC market potential and sales forecasts by brand Pricing strategy Managed care/Medicare influence 4. FUTUREVIEW FORECASTING MODEL Forecasts by therapeutic class and brand in this report are gener- ated with Kline's FutureView Scenario Forecasting Model, which provides Kline's forecasts for future switches and allows users to change assumptions to see how various scenarios may impact future switch sales. Subscribers can see how adjustments in the assumptions behind the forecasts can bring about different out- comes. www.KlineGroup.com Report #Y406C | © 2010 Kline & Company, Inc.
  • 4. Rx-to-OTC Switch Forecasts USA 2010 Methodology As the leading consultancy on Rx-to-OTC switches, Kline has developed a program based heavily on primary research (field and phone interviews) that has proven to be most effective and reliable in preparing switch forecasts. Rx-to-OTC-Switch Forecasts USA 2010 leverages our contacts in the industry and employs the use of primary research to capture insights and information available from a wide range of industry experts and opinion leaders. The field and phone interviews were conducted by Kline's professional staff with executives from the following functional areas: brand management, business development, marketing, R&D, scientific affairs, strategic planning, healthcare industry associations, managed care organizations, third party payers, and retailers. In addition to primary research, the study draws upon relevant secondary data, including regulatory information obtained from the FDA and patent searches. In forecasting Rx-to-OTC switches, a variety of factors are at play in each market that can affect the timing of switches. Competitive pressures, regulatory hurdles, and patent expirations each play significant roles in switch timing. Therefore, each brand is analyzed on a case-by-case basis, and the forecast time horizon may differ for each. Forecasts extend at least three years post-switch in each case. Forecasts in this report are generated with Kline's FutureView Scenario Forecasting Model. With the enhanced forecasts, subscribers can see how adjustments in the assumptions behind the forecasts can bring about different outcomes. Kline Credentials Kline is a worldwide consulting and research firm dedicated to providing the kind of insight and knowledge that helps companies find a clear path to success. The firm has served Recently published or in-progress research for the the management consulting and market research needs of organi- Healthcare industry includes: zations in the chemicals, materials, energy, life sciences, and Nonprescription Drugs USA consumer products industries for 50 years. OTC Innovations USA 1999-2009: Analysis of Factors for Success Kline's research and consulting services extend across the entire Impact of Recessions on the U.S. OTC Market healthcare industry value chain. Our solutions have helped clients Personal Care: U.S. Competitor Cost Structures develop better ways to create and profit from new business U.S. Retailers' Perceptions of OTC Drug opportunities, respond to competitive and economic threats, Marketers improve productivity, achieve sustainable growth, and optimize Rx-to-OTC Switch Strategies USA performance. Kline provides clients with facts, forecasts, and U.S. Consumers' Perceptions of OTC Drugs recommendations based solidly on the realities of the market. Nonprescription Drugs Canada OTC Drugs: U.S. Competitive Costs Structures Our market research reports and services are designed to provide 2010 subscribers with a deeper understanding of their markets, an outlook for their business, and accurate information about their competitors. Our clients tell us they often use Kline's market research to validate their own internal analysis, and many clients rely on Kline reports as their most critical source of information. For more information about this study or Kline's other services, e-mail us at sales@klinegroup.com, visit our website at www.KlineGroup.com, or contact us at any of our regional offices listed below. North America Latin America Europe Japan Asia India +1-973-435-6262 +55-11-3079-0792 +32-2-770-4740 +81-3-3242-6277 +86-21-6876-8600 +91-124-4546-100 www.KlineGroup.com Report #Y406C | © 2010 Kline & Company, Inc.