Abstract
With declining R&D productivity and maturing product portfolios, maximizing
revenues through lifecycle management has never been more important for
pharmaceutical companies. Upon patent expiry, companies risk losing up to 80%
of brand sales, highlighting the importance of implementing successful
strategies for brand protection and market expansion. Maximize revenue at all
stages of the product lifecycle and minimize the impact of generic competition
on your brand with the help of this new management report. 'Lifecycle
Management Strategies' is a new management report which provides practical
solutions to tackle the loss of market share to generic competition at patent
expiry. Strategies including Rx-to-OTC switching, indication expansion and
reformulation are evaluated in terms of product and developer characteristics,
economic viability and regulatory compliance. This will ensure that you are
able to select a strategy that will maximize return on investment and sustain
brand loyalty.
Table of Contents
Chapter 1 Introduction 18
- Summary 18
- The importance of lifecycle management 19
- Patent expiration 20
- Types of patents 20
- The value of patents 21
- Expiring patents on blockbusters 22
- Impact on drug revenues 24
- Cost containment and the rise of generics 24
- United States 24
- United Kingdom 27
- Germany 28
- France 29
- Italy 30
- Spain 31
- Patent challenges 32
- Case study: Lipitor (UK, US) 32
- Brand loyalty 34
- Strategic pricing 36
- Lifecycle management options 38
- Benefits and limitations of lifecycle management strategies 39
- Low product sales 40
- Patent expiration 40
- Niche products 42
- Lack of brand equity 42
- Ineffectiveness 42
- Side effects 43
- Uncompetitiveness 43
- Budgetary constraints 44
- Lack of research and development expertise 45
- Lack of strategic focus 45
- Trends in usage of lifecycle management strategies 46
- Conclusion 47
Chapter 2 Indication expansion 50
- Summary 50
- Introduction 51
- Objectives of indication expansion 52
- Prerequisites for a successful indication expansion 53
- When indication expansion is appropriate 53
- Strategic considerations 56
- Pricing 57
- Timing 58
- Benefits and limitations of indication expansion 59
- Benefits 60
- Limitations 60
- Case studies 63
- Betapace (US) -- unsuccessful indication expansion 63
- Singulair (US) -- successful indication expansion 64
- Conclusion 65
Chapter 3 Reformulation 68
- Summary 68
- Introduction 69
- Line extensions 70
- Objectives of reformulation 71
- Prerequisites for implementing a successful reformulation 72
- When reformulation is appropriate 73
- Strategic considerations 75
- Pricing 75
- Timing 75
- Benefits and limitations of reformulation 77
- Benefits 78
- Limitations 79
- Case studies 82
- Paxil (US) -- successful reformulation 82
- Prevacid (UK) -- unsuccessful reformulation 84
- Conclusion 86
Chapter 4 Second generation launch 88
- Summary 88
- Introduction 89
- Objectives of second generation launch 91
- Prerequisites for implementing a second generation launch 91
- When second generation launch is appropriate 92
- Combination products 94
- Strategic considerations 96
- Pricing 96
- Timing 97
- Benefits and limitations of second generation launch 98
- Benefits 99
- Limitations 100
- Case studies 103
- Nexium (US) -- successful next generation launch 103
- Conclusion 105
Chapter 5 Rx-to-OTC switching 108
- Summary 108
- Introduction 109
- The OTC market 110
- Rx-to-OTC switch regulation 111
- Objectives of switch 113
- When a switch is appropriate 114
- Industry pressure to switch 116
- Prerequisites for competing in the OTC market 117
- Strategic considerations 118
- Pricing 118
- Timing 119
- Benefits and limitations of Rx-to-OTC switch 119
- Benefits 121
- Limitations 122
- Case studies 125
- Claritin (US) -- successful Rx-to-OTC switch 125
- Prilosec (US) -- successful Rx-to-OTC switch 128
- Zocor (UK) -- unsuccessful Rx-to-OTC switch 129
- Conclusion 130
Chapter 6 Launch of a branded generic 132
- Summary 132
- Introduction 133
- The generics market 133
- Objectives of generic launch 135
- Prerequisites for competing in the generics market 135
- When a generic launch is appropriate 140
- Determining the attractiveness of a potential generic 140
- Proactive versus reactive launch decisions 143
- Opportunities arising from the US patent system 144
- Strategic considerations 145
- Pricing 145
- Timing 146
- Benefits and limitations of generic launch 147
- Benefits 148
- Limitations 149
- Case studies 151
- Capoten (Germany) -- successful generic launch 151
- Conclusion 152
Chapter 7 Divestiture 154
- Summary 154
- Introduction 155
- Out-licensing 155
- In-licensing 156
- Discontinuation 157
- Objectives of divestiture 158
- When divestiture is appropriate 159
- Strategic considerations 162
- Pricing 162
- Benefits and limitations of divestiture 163
- Benefits 164
- Limitations 165
- Case studies 166
- ElixSure (US) -- out-licensing 166
- Conclusion 167
Chapter 8 Appendix 170
- Primary research methodology 170
- Index 171
- Glossary 175
List of Figures
- Figure 1.1: Efficacy of lifecycle management strategies based on product
and owner characteristics 39
- Figure 1.2: Timing considerations for lifecycle management strategies 41
- Figure 1.3: Risk and return for lifecycle management strategies 44
- Figure 1.4: Implementation times and costs of lifecycle management
strategies 45
- Figure 1.5: Shifts in usage of lifecycle management strategies 46
- Figure 2.6: Breakdown of new indication launches by therapeutic area, 2005
55
- Figure 2.7: Pricing opportunities and threats for a new drug indication 57
- Figure 2.8: Efficacy of indication expansion based on owner and product
characteristics 59
- Figure 3.9: Efficacy of reformulation based on product and owner
characteristics 77
- Figure 3.10: Comparative benefits of drug reformulation 79
- Figure 4.11: Efficacy of second generation launch based on product and
owner characteristics 98
- Figure 5.12: Efficacy of Rx-to-OTC switch based on product, condition and
owner characteristics 120
- Figure 6.13: Average number of generics by market size 141
- Figure 6.14: Average generic price relative to brand by patent challenge
situation, 2003 - 2005 146
- Figure 6.15: Efficacy of generic launch based on product and owner
characteristics 148
- Figure 7.16: Drivers of drug divesture 159
- Figure 7.17: Efficacy of divestiture based on product and owner
characteristics 163
List of Tables
- Table 1.1: Revenues and patent expirations for selected companies'
blockbusters, 2005 23
- Table 2.2: Selected indication expansions for US commercialized drugs,
2000-05 54
- Table 3.3: Selected reformulations for US commercialized drugs 74
- Table 4.4: Selected second generation launches for US commercialized drugs
93
- Table 4.5: Selected combination products introduced in the US, 1999-2004 94
- Table 5.6: Non-prescription drug classification structure by country 109
- Table 5.7: US switches, 1995 - 2005 112
- Table 5.8: Switch environment by country 115
- Table 5.9: Key events leading to Claritin's switch in the US 116
- Table 5.10: In-house OTC capabilities of major pharmaceutical companies 117
- Table 6.11: In-house generics capabilities of major pharmaceutical
companies 136
- Table 6.12: US alliances between branded and generic manufacturers, 2001
-- 2005 138
- Table 7.13: Selected recent divestitures of US commercialized drugs, 2003
- 2005 162
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