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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