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

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Hatch waxman act

  • 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.