Practical Defense Strategies for Combating Generics Competition

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Importance of Defense Strategies
• What Does Pharma Stand to Lose?
• Overview of Potential Strategies
  • Company-Based Strategies
    • Mergers
    • Increase Emphasis on Biotech R&D
    • Improved Productivity and Reduced Risk Through Contract Research
    • Acquisition of a Generics Company
  • Product-Based Strategies
    • Additional Patents
    • New Isomers or Enantiomers
    • Modifi ed-Release Versions and Alternative Delivery Methods
    • Combination Products
    • New Indications/Switch to Over-the-Counter Promotion
• Litigation
  • Prospects for Success in the Courts
  • Authorized Generics Strategy
    • Is It Better to Litigate or Settle?
    • A Useful Short-Term Strategy
    • Challenges to the Authorized Generics Strategy
  • European Strategies
• Outlook

Tables

• 1. Sales of the Four Largest Domestic Generics Manufacturers in Japan, Fiscal Year Ended March 2006
• 2. Select Generics Defense Strategies
• 3. Generics Companies Bulk Up, 2006
• 4. Product-Specifi c Defense Strategies
• 5. Branded Drugs Authorized as Generics in 2006

Figure

• 1. Worldwide Share of Generics Market by Value of Sales, 2006
• 2. Blockbusters Facing Patent Expiry in 2007 (with 2006 Worldwide Sales)
• 3. New Chemical Entity (NCE) Launches, 1990-2005
• 4. Approvals of New Biopharmaceutical Products in the United States, 1990 Through October 2006
• 5. Ideal Timeline for Extending a Product' s Lifecycle
• 6. Authorized Generics Agreements, 1998-2006