Combating Generics 2008: Counter-Generics Strategy, Tactics and Execution

Table of Contents

Charts and Graphics

EXECUTIVE SUMMARY

• Figure E.1: Generic Entry Following Patent Expiration
• Figure E.2: Market Share Erosion Following Patent Expiration

Combating Generics: Five Principles for Success

• Figure E.3: Generics Defense Planning Begins (Relative to Product Age)
• Figure E.4: Functions Contributing to Counter-Generics Defense

COUNTER-GENERICS TACTICS, TIMING AND RESOURCES

• Figure 1.1: Counter-generics Planning Begins (Relative to Product Age)

A Matter of Timing: Developing and Implementing a Strategy

• Figure 1.2: Counter-generics Planning Begins (Relative to Patent Expiration)

Trends in the Prevalence of Counter-Generics Tactics

• Figure 1.3: Historical Data: Prevalence of Counter-Generics Strategies, 2004-2006
• Figure 1.4: Prevalence of Counter-Generics Strategies, 2005-2007
• Figure 1.5: Anticipated Counter-Generics Strategies, 2008-2010
• Figure 1.6: Changes in Counter-Generics Strategy
• Figure 1.7: Functions Contributing to Counter-Generics Defense

Staffing Resources

• Figure 1.8: Counter-Generics Headcounts Over Time

Brand Strategy Profiles

• Figure 1.9: Brand A' s Counter-Generics Strategy
• Figure 1.10: Brand B' s Counter-Generics Strategy
• Figure 1.11: Brand C' s Counter-Generics Strategy
• Figure 1.12: Brand D' s Counter-Generics Strategy
• Figure 1.13: Brand E' s Counter-Generics Strategy
• Figure 1.14: Brand F' s Counter-Generics Strategy
• Figure 1.15: Brand G' s Counter-Generics Strategy

FRONTLINE COUNTER-GENERICS TACTICS

Patent Litigation

• Figure 2.1: Prominence of Patent Litigation
• Figure 2.2: Use of Litigation (Relative to Patent Expiration)
• Figure 2.3: Time To Execute Litigation
• Figure 2.4: Investment in Litigation
• Figure 2.5: Prominence of Citizen Petitions

Filing Citizen Petitions

• Figure 2.6: Use of Citizen Petition (Relative to Patent Expiration)
• Figure 2.7: Time to Execute Citizen Petition
• Figure 2.8: Prominence of Pediatric Exclusivity

Pediatric Exclusivity

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

Defensive Pricing

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

Counter-Promotion

• Figure 2.18: Time To Execute Counter-Promotion
• Figure 2.19: Investment in Counter-Promotion

LIFECYCLE MANAGEMENT AND LINE EXTENSIONS

• Figure 3.1: Prevalence of Line Extension Strategies, 2005-2007

New Formulations

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

New Indications

• Figure 3.9: Use of New Indication
• Figure 3.10: Time to Execute New Indication
• Figure 3.11: Investment in New Indication

Next-Generation Products

• Figure 3.12: Prominence of Next-Generation Products
• Figure 3.13: Time to Execute Next-Generation Drug
• Figure 3.14: Use of Next-Generation Drug (Relative to Patent Expiration)
• Figure 3.15: Investment in Next-Generation Drug
• Figure 3.16: Transitioning Prilosec to Nexium
• Figure 3.17: Claritin/Clarinex Sales, 1999-2005
• Figure 3.18: Forest Laboratories' Antidepressant Franchise

Combination Therapies

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

MARKET CROSSOVER TACTICS

Authorized Generics

• Figure 4.1: Prominence of Authorized Generics
• Figure 4.2: Use of Authorized Generic (Relative to Patent Expiration)
• Figure 4.3: Time to Execute Authorized Generic
• Figure 4.4: Investment in Authorized Generic
• Figure 4.5: Barr' s Date of Entry for Generic Actiq
• Figure 4.6: Actiq-Related Sales, 2005-2007

Launching Authorized Generics through Subsidiary Generics Companies

• Figure 4.7: Prominence of Generics Subsidiaries
• Figure 4.8: Use of Generics Subsidiary (Relative to Patent Expiration)
• Figure 4.9: Time to Execute Generics Subsidiary
• Figure 4.10: Prominence of Rx-to-OTC Switching

RX-To-OTC Switching

• Figure 4.11: Use of RX-to-OTC (Relative to Patent Expiration)
• Figure 4.12: Time to Execute RX-to-OTC

GENERIC BIOLOGICS

• Figure 5.1: Omnitrope Timeline: EU & US Biosimilar Approval Processes