Overview

Companies

Metrics

Purchase

EXECUTIVE SUMMARY
Figure E.1: Generic Entry Following Patent Expiration..............13
Figure E.2: Market Share Erosion Following Patent Expiration..............13

Combating Generics: Five Principles for Success
Figure E.3: Generics Defense Planning Begins (Relative to Product Age)..............22
Figure E.4: Functions Contributing to Counter-Generics Defense..............25

 

COUNTER-GENERICS TACTICS, TIMING AND RESOURCES
Figure 1.1: Counter-generics Planning Begins (Relative to Product Age)..............31

A Matter of Timing: Developing and Implementing a Strategy
Figure 1.2: Counter-generics Planning Begins (Relative to Patent Expiration)..............33

Trends in the Prevalence of Counter-Generics Tactics
Figure 1.3: Historical Data: Prevalence of Counter-Generics Strategies, 2004-2006..............35
Figure 1.4: Prevalence of Counter-Generics Strategies, 2005-2007..............36
Figure 1.5: Anticipated Counter-Generics Strategies, 2008-2010..............38
Figure 1.6: Changes in Counter-Generics Strategy..............39
Figure 1.7: Functions Contributing to Counter-Generics Defense..............40

Staffing Resources
Figure 1.8: Counter-Generics Headcounts Over Time..............42

Brand Strategy Profiles
Figure 1.9: Brand A’s Counter-Generics Strategy..............44
Figure 1.10: Brand B’s Counter-Generics Strategy..............45
Figure 1.11: Brand C’s Counter-Generics Strategy..............46
Figure 1.12: Brand D’s Counter-Generics Strategy..............47
Figure 1.13: Brand E’s Counter-Generics Strategy..............48
Figure 1.14: Brand F’s Counter-Generics Strategy..............49
Figure 1.15: Brand G’s Counter-Generics Strategy..............50

 

FRONTLINE COUNTER-GENERICS TACTICS

Patent Litigation
Figure 2.1: Prominence of Patent Litigation..............57
Figure 2.2: Use of Litigation (Relative to Patent Expiration)..............58
Figure 2.3: Time To Execute Litigation..............59
Figure 2.4: Investment in Litigation..............60
Figure 2.5: Prominence of Citizen Petitions..............67
 

Filing Citizen Petitions
Figure 2.6: Use of Citizen Petition (Relative to Patent Expiration)..............68
Figure 2.7: Time to Execute Citizen Petition..............69
Figure 2.8: Prominence of Pediatric Exclusivity..............71

Pediatric Exclusivity
Figure 2.9: Use of Pediatric Exclusivity (Relative to Patent Expiration)..............72
Figure 2.10: Time To Execute Pediatric Exclusivity..............73
Figure 2.11: Falling Approval Rates: Requests for Pediatric Exclusivity Trials..............75
Figure 2.12: Prominence of Defensive Pricing..............78

Defensive Pricing
Figure 2.13: Investment in Defensive Pricing..............79
Figure 2.14: Time to Execute Defensive Pricing..............80
Figure 2.15: Use of Defensive Pricing (Relevant to Patent Expiration)..............81
Figure 2.16: Zocor Sales, 2003-2006..............83
Figure 2.17: Use of Counter-Promotion (Relative to Patent Expiration)..............84

Counter-Promotion
Figure 2.18: Time To Execute Counter-Promotion..............85
Figure 2.19: Investment in Counter-Promotion..............86

 

LIFECYCLE MANAGEMENT AND LINE EXTENSIONS
Figure 3.1: Prevalence of Line Extension Strategies, 2005-2007..............92

New Formulations
Figure 3.2: Prevalence of Counter-Generics Strategies, 2005-2007..............95
Figure 3.3: Prominence of New Formulations..............95
Figure 3.4: Use of New Formulation (Relative to Patent Expiration)..............96
Figure 3.5: Time to Execute New Formulation..............97
Figure 3.6: Investment in New Formulation..............98
Figure 3.7: Glucophage Franchise Sales, 2000-2004..............99
Figure 3.8: Prominence of New Indications..............101

New Indications
Figure 3.9: Use of New Indication..............102
Figure 3.10: Time to Execute New Indication..............103
Figure 3.11: Investment in New Indication..............104

Next-Generation Products
Figure 3.12: Prominence of Next-Generation Products..............106
Figure 3.13: Time to Execute Next-Generation Drug..............107
Figure 3.14: Use of Next-Generation Drug (Relative to Patent Expiration)..............108
Figure 3.15: Investment in Next-Generation Drug..............109
Figure 3.16: Transitioning Prilosec to Nexium..............112
Figure 3.17: Claritin/Clarinex Sales, 1999-2005..............115
Figure 3.18: Forest Laboratories’ Antidepressant Franchise..............118

Combination Therapies
Figure 3.19: Prominence of Combination Products..............121
Figure 3.20: Historical Data: Prevalence of Counter-Generics Strategies, 2004-2006..............121
Figure 3.21: Investment in Combination Drug..............122
Figure 3.22: Use of Combination Drug (Relative to Patent Expiration)..............123
Figure 3.23: Time to Execute Combination Drug..............124

 

MARKET CROSSOVER TACTICS

Authorized Generics
Figure 4.1: Prominence of Authorized Generics..............130
Figure 4.2: Use of Authorized Generic (Relative to Patent Expiration)..............131
Figure 4.3: Time to Execute Authorized Generic..............132
Figure 4.4: Investment in Authorized Generic..............133
Figure 4.5: Barr’s Date of Entry for Generic Actiq..............134
Figure 4.6: Actiq-Related Sales, 2005-2007..............136

Launching Authorized Generics through Subsidiary Generics Companies
Figure 4.7: Prominence of Generics Subsidiaries..............140
Figure 4.8: Use of Generics Subsidiary (Relative to Patent Expiration)..............141
Figure 4.9: Time to Execute Generics Subsidiary..............142
Figure 4.10: Prominence of Rx-to-OTC Switching..............144

RX-To-OTC Switching
Figure 4.11: Use of RX-to-OTC (Relative to Patent Expiration)..............145
Figure 4.12: Time to Execute RX-to-OTC..............146

GENERIC BIOLOGICS
Figure 5.1: Omnitrope Timeline: EU & US Biosimilar Approval Processes..............155