Abstract
Protect brand revenues with a multi-tiered counter-generics strategy:
Generic drugs now account for more than 60% of all prescriptions filled in the US, and more than $60 billion worth of drugs face US patent expiration by 2011.
Use this report to build a counter-generics strategy that includes long-term, R&D-based lifecycle planning (such as new formulations and next-generation drugs) as well as frontline tactics (such as litigation and counter-promotion) -- and understand how companies launch authorized generics and attempt OTC switches
Explore primary data for a comprehensive look at current counter-generics defense:
- Investigate strategies, investments and results for seven brands
- Benchmark your efforts against timelines, investment levels, and
past-and-future use of critical lifecycle management and counter-generics
options:
- New formulation launches
- Defensive pricing changes
- Counter-promotion
- Approval for new indications
- Next-generation product launches
- Patent litigation
- Authorized generics negotiations
- Launches through generics subsidiaries
- Pediatric trials and six-month exclusivity
- OTC switching
- Compare headcounts dedicated to counter-generics preparation over the life of a brand
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
