Combating Generics 2008: Counter-Generics Strategy, Tactics and Execution (PH105)

Published by: Cutting Edge Information

Published: Oct. 1, 2007 - 156 Pages

Table of Contents

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

Abstract

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

Get Full Details About This Report >>

About MarketResearch.com
MarketResearch.com is an online aggregator selling over 160,000 market research reports, company profiles and country profiles from over 600 research firms. Our reports will provide you with the critical business and competitive intelligence you need for strategic planning and marketing research. Coverage includes the US, UK, Europe, Asia and global markets.