Authorized Generics: Look Before You Leap

Table of Contents

• Executive Summary
• Strategic Considerations
• Stakeholder Implications
• Paragraph IV Challenges: An Overview
• The Current Landscape for Authorized Generics
• Strategies for Dealing with Exclusive Generics
• Consolidation and Integration of Brand and Generic Activities
• Discounting and Price Negotiations
• Generic Erosion
• Historic Patterns: Multiple Generics Enter the Market Upon Patent Expiry
• Generic Erosion with 180-Day Exclusivity: One Brand, One Generic
• The Payer Perspective: Can a Generic That Is Priced Lower Result in Less Savings?
• Generalizable Rates of Erosion for Brands
• Implications for Authorized Generics
• Generic Erosion and the Authorized Generic Strategy
• Sidebar: How Can an Exclusive Generic Cost More than a Brand-Name Drug?
• The Three Competitive Scenarios: Example 1
• The Three Competitive Scenarios: Example 2
• A Recent Example of an Authorized Generic Strategy
• Authorized Generics: Not the Only Option

Tables

• 1. Select Brand Companies and Their Generic Subsidiaries
• 2. Key Payer Segments
• 3. Brand-Name Drug' s Share of the Market Under Two Scenarios
• Sidebar Table. Drug Pricing Chain
• 4. Generic Erosion: Three Competitive Scenarios
• 5. Generic Erosion in Three Basic Competitive Scenarios: Another Example

Figures

• 1. Historic Generic Erosion Rates of Drugs Facing Multiple Generic Competition
• 2. Generic Erosion Rates of Drugs Facing a Single Generic Competitor During the First 180 Days of Generic Entry
• 3. General Projected Brand Erosion to Generics During the First 180 Days of Generic Entry