The Hatch-Waxman Act established regulations for generic drugs in the US to facilitate generic competition. It created an Abbreviated New Drug Application process for generics to gain approval more quickly by showing bioequivalence to branded drugs. The first generic to challenge a patent via Paragraph IV certification gains 180 days of marketing exclusivity. The Act also allows patent term extensions for branded drugs to compensate for regulatory approval times. While increasing generic competition, it provides benefits to branded manufacturers such as data and market exclusivities as well as patent dispute resolutions.

1. HATCH-WAXMAN ACT
Presented by: Arun Agarwal
(CSIR-JRF)
ID: 53253
Supervisor: Dr. Wahajuddin
(Principal scientist)
Division: Pharmaceutics and
pharmacokinetics

2. Contents
 Introduction
 Objectives of the act
 New drug approval
 Generic drug approval
 Challenging patent excluvities
 Anda exclusivity
 Patent term extension
 Benefits for branded drug manufacturers
 Loopholes of the 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:
 The new drug is safe and effective
 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. Challenging patent exclusivity
 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.

8. 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.

9. 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

10. 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)

11. 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.

12. 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.

13. References
 https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/hatch-
waxman-letters. (Accessed on: 09 October 2019).
 Ohly, D. C. and S. K. Patel (2010). "The Hatch-Waxman act: prescriptions for
innovative and inexpensive medicines." U. Balt. Intell. Prop. LJ 19: 107.

14. Thank you!!