Now Available as Part of CHI's
Network of Affiliated Reports

Indication Expansion: Opportunities for successful lifecycle management

CHAPTER 1: INTRODUCTION
  • The importance of indication expansion
  • When an indication expansion is appropriate
  • Types of indication expansion
    • Expanded drug usage conditions
    • Extension to related indications
    • Extension to additional indications
  • Prerequisites for a successful indication expansion
  • Objectives of indication expansion
  • Benefits of indication expansion
  • Building additional revenue streams for a drug
  • Mitigating the effects of patent expiration
    • The value of patents
    • Types of patents
    • Cost containment and the rise of generics
    • United States
    • United Kingdom
    • Germany
    • France
    • Italy
    • Spain
    • Impact on drug revenues
    • Expiring patents on blockbusters
    • Patent challenges
    • Case study: Lipitor
  • Limitations of indication expansion
  • Trends in indication expansion
    • Indication Removal
  • Conclusion

CHAPTER 2: EXTENSION TO RELATED INDICATIONS
  • Introduction
  • Treatment-prevention extensions
    • Disease severity extensions
    • Case study: Aricept
    • Extensions to disease variants
    • Case study: Hycamtin
  • When an indication extension is appropriate
  • Objectives of indication extension
  • Benefits of indication extension
  • Limitations of indication extension
  • Conclusion

CHAPTER 3: EXTENSION TO NEW APPLICATIONS
  • Introduction
  • When a new application extension is appropriate
    • New application extensions within drug families
    • Case study: Acomplia
  • Objectives of new application extension
  • Benefits of new application extension
    • Repositioning
    • Case Study: Lyrica
    • Case Study: Botox
  • Limitations of new application extension
  • Conclusion

CHAPTER 4: PEDIATRIC AND SPECIAL POPULATION EXTENSIONS
  • Introduction
  • Pediatric extensions
  • Gender-based extensions
    • Geriatric extensions
  • When a pediatric or special population extension is appropriate
  • Objectives of pediatric and special population extensions
  • Benefits of pediatric and special population extensions
    • United States
    • Pediatric Research Equity Act of 2003
    • Chances of Pediatric Exclusivity Renewal in 2007
    • Europe
    • Case study: Claritin and Zyrtec
  • Limitations of pediatric and special population extensions
    • Case study: Norvasc
  • Conclusion

CHAPTER 5: EXTENSION OF USAGE CONDITIONS
  • Introduction
  • Monotherapy extensions
    • Case Study: Topamax
    • Combination therapy extensions
    • Other usage extensions
  • When a usage extension is appropriate
  • Objectives of usage extension
  • Benefits of usage extension
    • Case study: Femara
  • Limitations of usage extension
    • Case study: torcetrapib
  • Conclusion