This document summarizes the Hatch-Waxman Act, which established regulations for generic drugs in the US. It facilitated generic drug approval through the ANDA process and provided incentives for innovation by granting patent term extensions and periods of market exclusivity. However, it also created loopholes like authorized generics that brand name drugs could exploit to extend their market monopoly. Overall, the Act sought to balance increased generic competition with continued incentives for pharmaceutical innovation.

1. HATCH-WAXMAN ACT
PRESENTED BY- ANAMIKA DEY
ROLL NO- MPH/10009/19

2. CONTENTS
■ INTRODUCTION
■ OBJECTIVES OFTHE ACT
■ NEW DRUG APPROVAL
■ GENERIC DRUG APPROVAL
■ CHALLENGING PATENT EXCLUVITIES
■ ANDA EXCLUSIVITY
■ PATENTTERM EXTENSION
■ BENEFITS FOR BRANDED DRUG MANUFACTURERS
■ LOOPHOLESOFTHE ACT
■ CONCLUSION

3. INTRODUCTION
■ It is also known as “ The drug price competition
and patent term restoration act”.
■ It was proposed by Orrin Hatch and Henry A.
Waxman.
■ Effective since 24 September, 1984
■ It facilitated the growth of generic industry
■ The bill altered the pharmaceutical industry substantially
as it established government regulations for generic
drugs in the United States and made it a lot easier for
generic drugs to enter the market.

4. Objectives of the act
■ The original intent of the act was to increase generic drug
availability in the market and make drugs more affordable.
■ The act sought to achieve the objective of increasing
competition with the introduction of a greater number of
generic drugs in timely manner and rewards innovators with
increased patent terms during which they enjoy market
exclusivity.
■ The Hatch Waxman Act amended the FD&C Act and created
Abbreviated New Drug process to submit generic drugs to the
FDA for approval.
■ It also compensates the branded drug manufacturers for the
time lost from the patent term because of the regulatory
approval formality.

5. NEW DRUG APPROVAL
■ The FDA requires every new drug to be safe and effective.
■ A branded drug company seeking FDA approval to market a
new drug must submit an NDA (New Dug Application) to
FDA. The information provided in the NDA allows FDA to
determine whether:
1) The new drug is safe and effective
2) Certain other regulatory requirements are met,
such as those concerning good manufacturing practices.
■ Obtaining and submitting this information is a time consuming
process as it requires many extensive and clinical trials.

6. GENERIC DRUG APPROVAL
■ Under the HATCH-WAXMAN Act, generic drug companies
can typically file an ANDA (Abbreviated New Drug
Application) to FDA.
■ Generic drug applications are required to prove that they are
therapeutically equivalent to innovator drugs.This is
accomplished by demonstrating:
• Bio equivalence
• Pharmaceutical equivalence
• Compliance with cGMP requirements

7.  Generic drugs were also required to include certifications of the
status of all patents to the reference innovator drug. Accordingly
the generic submission are categorized as:
PARAGRAPH I FILINGS: No patent information has been
previously submitted to the FDA.
PARAGRAPH II FILINGS: All the submitted patents relevant
to drug have expired.
PARAGRAPH III FILINGS: If the applicant states that he
intends to market the drug only after the expiry of the listed patents.
PARAGRAPH IV FILINGS: If the applicant certifies that any
product or used patent is invalid or will not be infringed by the generic
drug approval.
Challenging patent exclusivity

9. Anda exclusivity
■ The first filer of ANDA with a Paragraph IV Certification
concerning an reference listed drug (RLD) is potentially
entitled to a 180 day period during which the FDA will not
approve any other ANDA having a Paragraph IV certification
for a generic version of RLD.
■ Thus, first filer exclusivity blocks final approval of other
ANDAs with Paragraph IV certification for 180 days.

10. PATENT TERM EXTENSION
■ The Hatch WAXMAN Act provides a patent term extension for
patents covering certain products including human drug
products, that are subject to FDA approval. Only one
extension can be granted in connection to a particular
product, and it must be for a patent that claims either a:
A) Drug product, that is, the active ingredient and any
approved drug using that active ingredient.
B) Method of using that drug product
C) Method of manufacturing a drug product

11. Benefits for branded
manufacturers
 Orange book provides public notice of patents drugs.
 Allows for resolution of patent disputes prior to generic entry.
 30 months stay of FDA approval of generic
 Patent term restoration.
 Allows for several market exclusivities
A)Data Exclusivity-
1) 5 years for new chemical entity
2) 3 years for new clinical study exclusivity
B)Orphan drug(7 years)
C)Pediatric drug(6 months)

12. LOOPHOLES OF THE ACT
■ AUTHORIZED GENERICS- They are pharmaceutical products that
are approved as brand-name drugs but marketed as generic drugs.
Authorized generics do not bear the trademark of the
manufacturer but are manufactured to the brand’s specifications.
■ WAREHOUSING PATENTS- An innovator may patent multiple
attributes of a product (may be color, manufacturing process),
essentially forcing the generic to hose between waiting for the
patents to expire or file a para IV litigation and associated
costs and delays.

13. CONCLUSION
■ The HATCH WAXMAN Act provides an expedited USFDA
program for speedy generic entry and market exclusivity.
■ The HATCH WAXMAN Act allows for a patent term extension
of a maximum of 5 years for the branded drug manufacturer
to compensate for the time lost during the NDA approval by
the US FDA.