Market Report Source

Overview

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

Companies Mentioned in this 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

Table of Contents

EXECUTIVE SUMMARY
Figure E.1: Generic Entry Following Patent Expiration…...........13
Figure E.2: Market Share Erosion Following Patent Expiration…...........13

Combating Generics: Five Principles for Success
Figure E.3: Generics Defense Planning Begins (Relative to Product Age)..............22
Figure E.4: Functions Contributing to Counter-Generics Defense…...........25

COUNTER-GENERICS TACTICS, TIMING AND RESOURCES
Figure 1.1: Counter-generics Planning Begins (Relative to Product Age)..............31

A Matter of Timing: Developing and Implementing a Strategy
Figure 1.2: Counter-generics Planning Begins (Relative to Patent Expiration)..............33

Trends in the Prevalence of Counter-Generics Tactics
Figure 1.3: Historical Data: Prevalence of Counter-Generics Strategies, 2004-2006…...........35
Figure 1.4: Prevalence of Counter-Generics Strategies, 2005-2007…...........36
Figure 1.5: Anticipated Counter-Generics Strategies, 2008-2010…...........38
Figure 1.6: Changes in Counter-Generics Strategy…...........39
Figure 1.7: Functions Contributing to Counter-Generics Defense…...........40

Staffing Resources
Figure 1.8: Counter-Generics Headcounts Over Time…...........42

Brand Strategy Profiles
Figure 1.9: Brand A’s Counter-Generics Strategy…...........44
Figure 1.10: Brand B’s Counter-Generics Strategy…...........45
Figure 1.11: Brand C’s Counter-Generics Strategy…...........46
Figure 1.12: Brand D’s Counter-Generics Strategy…...........47
Figure 1.13: Brand E’s Counter-Generics Strategy…...........48
Figure 1.14: Brand F’s Counter-Generics Strategy…...........49
Figure 1.15: Brand G’s Counter-Generics Strategy…...........50

FRONTLINE COUNTER-GENERICS TACTICS
Patent Litigation
Figure 2.1: Prominence of Patent Litigation…...........57
Figure 2.2: Use of Litigation (Relative to Patent Expiration)..............58
Figure 2.3: Time To Execute Litigation…...........59
Figure 2.4: Investment in Litigation…...........60
Figure 2.5: Prominence of Citizen Petitions…...........67

Filing Citizen Petitions
Figure 2.6: Use of Citizen Petition (Relative to Patent Expiration)..............68
Figure 2.7: Time to Execute Citizen Petition…...........69
Figure 2.8: Prominence of Pediatric Exclusivity…...........71

Pediatric Exclusivity
Figure 2.9: Use of Pediatric Exclusivity (Relative to Patent Expiration)..............72
Figure 2.10: Time To Execute Pediatric Exclusivity…...........73
Figure 2.11: Falling Approval Rates: Requests for Pediatric Exclusivity Trials…...........75
Figure 2.12: Prominence of Defensive Pricing…...........78

Defensive Pricing
Figure 2.13: Investment in Defensive Pricing…...........79
Figure 2.14: Time to Execute Defensive Pricing…...........80
Figure 2.15: Use of Defensive Pricing (Relevant to Patent Expiration)..............81
Figure 2.16: Zocor Sales, 2003-2006…...........83
Figure 2.17: Use of Counter-Promotion (Relative to Patent Expiration)..............84

Counter-Promotion
Figure 2.18: Time To Execute Counter-Promotion…...........85
Figure 2.19: Investment in Counter-Promotion…...........86

LIFECYCLE MANAGEMENT AND LINE EXTENSIONS
Figure 3.1: Prevalence of Line Extension Strategies, 2005-2007…...........92

New Formulations
Figure 3.2: Prevalence of Counter-Generics Strategies, 2005-2007…...........95
Figure 3.3: Prominence of New Formulations…...........95
Figure 3.4: Use of New Formulation (Relative to Patent Expiration)..............96
Figure 3.5: Time to Execute New Formulation…...........97
Figure 3.6: Investment in New Formulation…...........98
Figure 3.7: Glucophage Franchise Sales, 2000-2004…...........99
Figure 3.8: Prominence of New Indications…...........101

New Indications
Figure 3.9: Use of New Indication…...........102
Figure 3.10: Time to Execute New Indication…...........103
Figure 3.11: Investment in New Indication…...........104

Next-Generation Products
Figure 3.12: Prominence of Next-Generation Products…...........106
Figure 3.13: Time to Execute Next-Generation Drug…...........107
Figure 3.14: Use of Next-Generation Drug (Relative to Patent Expiration)..............108
Figure 3.15: Investment in Next-Generation Drug…...........109
Figure 3.16: Transitioning Prilosec to Nexium…...........112
Figure 3.17: Claritin/Clarinex Sales, 1999-2005…...........115
Figure 3.18: Forest Laboratories’ Antidepressant Franchise…...........118

Combination Therapies
Figure 3.19: Prominence of Combination Products…...........121
Figure 3.20: Historical Data: Prevalence of Counter-Generics Strategies, 2004-2006…...........121
Figure 3.21: Investment in Combination Drug…...........122
Figure 3.22: Use of Combination Drug (Relative to Patent Expiration)..............123
Figure 3.23: Time to Execute Combination Drug…...........124

MARKET CROSSOVER TACTICS
Authorized Generics
Figure 4.1: Prominence of Authorized Generics…...........130
Figure 4.2: Use of Authorized Generic (Relative to Patent Expiration)..............131
Figure 4.3: Time to Execute Authorized Generic…...........132
Figure 4.4: Investment in Authorized Generic…...........133
Figure 4.5: Barr’s Date of Entry for Generic Actiq…...........134
Figure 4.6: Actiq-Related Sales, 2005-2007…...........136

Launching Authorized Generics through Subsidiary Generics Companies
Figure 4.7: Prominence of Generics Subsidiaries…...........140
Figure 4.8: Use of Generics Subsidiary (Relative to Patent Expiration)..............141
Figure 4.9: Time to Execute Generics Subsidiary…...........142
Figure 4.10: Prominence of Rx-to-OTC Switching…...........144

RX-To-OTC Switching
Figure 4.11: Use of RX-to-OTC (Relative to Patent Expiration)..............145
Figure 4.12: Time to Execute RX-to-OTC..............146

GENERIC BIOLOGICS
Figure 5.1: Omnitrope Timeline: EU & US Biosimilar Approval Processes…...........155