Contents:

Executive Summary Combating Generics: The Challenges Ahead Methodology and Definitions Combating Generics: Five Principles for Success Counter-Generics Tactics, Timing and Resources A Matter of Timing: Developing and Implementing a Strategy Trends in the Prevalence of Counter-Generics Tactics Staffing Resources Brand Strategy Profiles Brand A’s Counter-Generics Strategy Brand B’s Counter-Generics Strategy Brand C’s Counter-Generics Strategy Brand D’s Counter-Generics Strategy Brand E’s Counter-Generics Strategy Brand F’s Counter-Generics Strategy Brand G’s Counter-Generics Strategy Frontline Counter-Generics Tactics Patent Litigation Filing Citizen Petitions Pediatric Exclusivity Defensive Pricing Counter-Promotion Line Extensions New Formulations New Indications Next-Generation Products Combination Therapies Market Crossover Tactics Authorized Generics Current Trends in Authorized Generics Launching Authorized Generics through Subsidiary Generics Companies RX-To-OTC Switching Generic Biologics 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

Companies Mentioned

- Abbott Laboratories - AstraZeneca - Bausch & Lomb - Bayer Schering Pharma - Fibrogen - Forest Laboratories - GammaCan - GlaxoSmithKline - Implicit Bioscience - Janssen - Janssen-Cilag - Johnson & Johnson - MedImmune - Merck & Co. - Merck KGaA - Novartis - Pfizer - PharmaDerm - Prestwick Pharmaceuticals - Quintiles - Roche - Sanofi-Aventis - Solvay - Spectrum Pharmaceuticals - ViroPharma - Wyeth