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Generic Drugs

Combating Generics 2008

Counter-Generics Strategy, Tactics and Execution

Publication Date   December 2007
Publisher   Cutting Edge Information
Product Type   Report
Pages   159
ISBN Number   not applicable
Product Code   CUT028
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Price £3,880.00

approximately: $7,250 | €4,921

Summary


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 tcounter-generics preparation over the life of a brand

Companies Included in Report

  • 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

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