Contents

• Author: Kenneth Dorsney
• Pages: 7-21

Contents

Foreword xxiii

Preface xxv

CHAPTER 1

The Statutory and Regulatory Scheme 1

I. The Drug Price Competition and Patent Term Restoration Act

of 1984 (aka the Hatch-Waxman Act) 1

II. Statutory Overview and Specific Amendments 3

A. General Compromise 3

B. Legislative Foundation and Subsequent Amendments 4

III. Statutory Balancing: Incentives toPatenteesandGenerics 6

A. New Drug Application Filers 7

B. ANDA Filers 20

CHAPTER 2

The Drug Approval Process—An Overview 29

I. Pre-NDA Filing 30

II. NDA Filing and Post-NDA Filing 31

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

under the ANDA Process 33

CHAPTER 3

Notice and Prefiling Considerations 37

I. The NDA Owner’s Pre–Notice Letter Investigation 37

A. Timeline for Receiving the Notice Letter 37

B. Presuit Due Diligence and Review of Orange Book Listings 39

II. Paragraph IV Notice Letters 46

A. Requirements 46

B. Estoppel and Reservation of Rights 47

C. Confidentiality 48

D. Considerations for the Notice Letter Recipient 49

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