Contents

• Author: Kenneth Dorsney
• Pages: 7-18

vii

Contents

Foreword xix

Preface xxi

CHAPTER 1

Statutory and Regulatory Scheme 1

I. The Drug Price Competition and Patent Term Restoration Act

of 1984 (aka The Hatch-Waxman Act) 1

A. Impetus for Reform 1

II. Statutory Overview and Specific Amendments 3

A. General Compromise 3

B. Subsequent Amendments 4

III. Statutory Balancing: Incentives to Patentees and Generics 5

A. New Drug Application Filers 5

B. ANDA Filers 17

CHAPTER 2

Drug Approval Process—An Overview 25

I. Pre-NDA Filing 26

II. NDA Filing and Post-NDA Filing 27

III. The FDA Process for Securing Drug Approval for a Drug Under

the ANDA Process 29

CHAPTER 3

Notice and Pre-Filing Considerations 33

I. The NDA Owner’s Pre-Notice Letter Investigation 33

A. Timeline for Receiving the Notice Letter 33

B. Pre-Suit Due Diligence and Review of Orange Book Listings 35