Combating Generics 2008

Content

• 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