Table of Contents
- Executive Summary
- Strategic Implications
- Stakeholder Implications
- Generic Pharmaceuticals
- The Changing Landscape of Pharmaceutical Patent Litigation Risk
- Hatch-Waxman Act
- Strategic Use of the Hatch-Waxman Procedure
- Hatch-Waxman Procedure
- Authorized Generics and the 180-Day "Incentive"
- The Growing Challenge to Patents-Interaction of Patent and Drug Law
- Coordinating Patent and NDA Submissions
- Sameness Requirements
- Petitioning the FDA
- The Citizen Petition
- The Zocor Case-Merck Declines to Sue, then De-Lists Its Patents
- "Carve-Out" and "Section viii Statement"
- 505(b)(2) NDA Application
- Biogenerics-"Follow-On" Biologicals
- Patent Litigation
- Outlook
Tables
- 1. Select Authorized Generic Launches, 2005-2007
- 2. Coordination of Patent and Regulatory Strategies
- 3. Select Generics Company Mergers and Acquisitions, 1996-2006
Figures
- 1. Dollar Value of Brand Drugs Going Off-Patent, 1995-2010
- 2. Receipts of Original Abbreviated New Drug Applications (ANDAs),
2001-2006
- 3. Approvals and Tentative Approvals of ANDAs, 2000-2006
- 4. Hatch-Waxman Framework for Litigation
- 5. Abbreviated New Drug Applications (ANDAs) Filed With Paragraph IV
Certifications,2003-2006
- 6. Sales of Drugs Challenged With a Paragraph IV Patent Certification, 2005
- 7. Pharmaceutical Risk Management and Coordinated Patent and Drug Analysis
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