HATCH-WAXMAN

ACT AND
AMENDMENTS
 INTRODUCTION
• Also known as Drug Price Competition and Patent Term
Restoration Act

• Enacted in 1984

• Amended the patent laws

• Generic companies were required to submit their own

comprehensive NDA which were costly and time
consuming .
• Before 1962- new drug approval based on safety alone.
 FEATURES
• Duplication of expensive and time consuming clinical and non -clinical
studies are eliminated.

• Act expedites the availability of generic drug product, provided the patent
right does not infringe. Approval process is established separately for
generic drug products.

• A 180 days period is provided to first generic product introduction.

• Act compensates the innovator’s perceived losses due to competition

from generic drug products.
• For some brands products, the term patent is extended for
additional 5 years in the name of EXCLUSIVITY.

• EXCLUSIVITY : it means award/reward of marketing

protection. This is applicable to active ingredient alone or
the use of active ingredient in a product or both.

• The act provides 3 years ‘free from generic competition’

for the approval of an NDA or supplemental NDA for a
drug product containing previously approved active
ingredient.
 TYPES OF
EXCLUSIVITY
• NEW CHEMICAL ENTITY
• 5 YEARS
(NCE)

• OTHER EXCLUSIVITY
• 3 YEARS

• ORPHAN DRUG
• 7YEARS
EXCLUSIVITY (ODE)
• 6 MONTHS
• PEDIATRIC DRUG
EXCLUSIVITY (PDE)
 BOLAR AMENDMENT
• It comes under Drug Price Competition and Patent Term
Restoration Act.

• The firms interested to introduce the generic drug product

may seek the approval from the FDA in a time frame.

• This firms must follow the related patent laws and provide
certificate that the patent is invalid or not infringed by the
generic product.
CODE OF FEDRAL
REGULATION (CFR)
 WHAT IS CFR?

• The code of federal regulation is the codification of the

general and permanent rules and regulation published in
the Federal Register by the executive departments and
agencies of the federal government of United States.

• The CFR is divided into 50 titles.

• Each title is further divided into chapters, subchapters,

parts and section.
 HISTORY
• The Federal Register Act- amended in 1937 to provide a
“codification” of all regulation every five years -known as
code of federal regulation.

• The first edition of the CFR was published in 1938 and

included all finalised regulation that were published in
Federal Register from March 14, 1936 to June 1,1938.
 CFR TITLE 21
• Title 21 of CFR is reserved for rules of Food and Drug
Administration.

• 21 CFR consist of 1499 parts.

• It is divided into three chapters:

1.Chapter 1- Food and Drug administration

2. Chapter 2- Drug Enforcement administration

3. Chapter 3- Office of National Drug Control Policy

 RESEARCH TOOLS IN CFR

• TABLE OF CONTENTS : CFR title are

broken down by chapters, subchapters, and part.

• TABLE OF CFR TITLES AND CHAPTERS:

Redesignation tables to help trace new location of
parts and section of a regulation.

• LIST OF CFR SECTIONS AFFECTED IN THE

VOLUME: List of CFR sections affected in each
volume indicates the type of change that was made.