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Hatch-Waxman Act &
Amendments
Presented by – Dhakane Sumeet S.
JSPM’S Rajrshi Shahu College Of Pharmacy And Research
M. Pharm Pharmaceutics
1
Introduction
 Also called as Drug Price Competition and Patent Term
Restoration Act 1984.
 This act established approval pathway for Generic drug
ANDA
 This act encourages manufacturer of generic drug
 Enacted in 1984
 Henry Waxman of California sponsored the act
2
History
 Before 1962 new drug approval was based on safety only
 In 1962 Efficacy made compulsory for marketing approval.
 Before this act there was no provision for patent term extension.
 Generic drug companies were required to submit comprehensive
NDA which was costly & Time consuming.
 If any drug was covered by patent, testing could not begin until
patent is expired
3
Objectives
 Reducing cost associated with approval of generic drug.
 Allow early experimental use.
 Motivating generic drug manufacturer.
 For getting marketing approval for generic drug without
conducting clinical trial.
 Patent term extension. (to compensate time lost in process)
4
General provisions-
creation of section 505 (j)
 This act amended federal food and Drug act and created
approval process for generic drug with section 505 (j)
 This Established Abbreviated NDA (ANDA )approval process.
 This Act allows generic version of previously approved innovator
drug without submitting NDA.
 ANDA refers previously approved NDA and relies on agency's
finding of safety and effectiveness of listed product.
5
Contd.
 Time required for ANDA approval depends on parts of patent
protection of innovator drug.
 This law established process that
- applicant need to certify patent listed.
- & provide notice to NDA holder and patent owner.
 If patent litigation is filled it can impose 30 month stay on
approval of ANDA
6
Contd.
 When applicant submit ANDA he/she must certify one of the
following things under section 505(j)(2)(A)viii
• Para I – This certify that patent is not filled.
• Para II - This certify that patent is expired.
• Para III – This certify that patent will expire on particular date.
• Para IV – This certify that patent is invalid or will not be infringed
by drug for which process is begun
7
Generic drug
Manufacturer
Warns notice
Brand manufacturer/ innovator
& explains either patent is expired
/ invalid / or not be violated by
generic version
In reply
Innovator can fill
Patent Infringement
If filled after
45 days
If filled within
45 days
No action by FDA
No approval by
FDA for 30 month if
patent is Infringed
After 30 month FDA will
decide it should be
granted or Not
8
Amendments
A) New Drug Exclusivity
i) Non-patent Exclusivity
1) Orphan Drug Exclusivity
 It is granted to drug that treat disease or condition which
affects less than 2 lakh people in US. Or
 For those it is unlikely that US sales will recoup its
development cost.
 Valid For 7 Years.
 But only applicable for use of drug treating rare disease or
condition.
9
2) New Chemical Entity (NCE) Exclusivity
 Granted only if FDA not previously approved that NCE.
 NCE prevents Generic Company from filling application for
approval of generic drug for 5 years from 1st approval of NDA
 Generic company may file ANDA with para IV certification 4
year after NDA approval
10
3) New Clinical Study Exclusivity
 It is applicable when new clinical study leads new Formulation
or Changed dosing regimen.
 If applicant is applying through this exclusivity he/she must
submit report of clinical investigation conducted, this will be
essential for approval.
 This is also called as Data Exclusivity.
 This prohibit FDA from approving generic drug application for
new dosage form or use for 3 year.
11
4) Pediatric Drug Exclusivity
 It is applicable only when FDA request NDA holder to conduct
study of drug with pediatric population
 This adds the patent / marketing exclusivity for 6 month
Exclusivity Type Term
Orphan Drug Exclusivity 7 Year
New Chemical Entity (NCE) Exclusivity 5 Year
New Clinical Study Exclusivity 3 Year
Pediatric Drug Exclusivity 6 Months
Generic Markating 180 Days
12
ii) Patent Exclusivity / Orange Book
 NDA holder must provide FDA with Patent number &
Expiration date of patent that claims
- drug, API, Formulation of active ingredient or
- method of using drug intermediate or .
method of making drug
 When FDA approves New Drug Application, FDA publishes
the patent information in FDA’s approved product with
therapeutic equivalence determining Publication which is
known as orange book
13
Challenging Patent Exclusivity
 As already mentioned in provision.
 A generic company submitting ANDA application must make
one of following certification for each patent.
• Para I – This certify that patent is not filled.
• Para II - This certify that patent is expired.
• Para III – This certify that patent will expire on particular date.
• Para IV – This certify that patent is invalid or will not be
infringed by drug for which process is begun
14
 Para IV certification is potential trigger for hatch-Waxman act
patent litigation
 Filling application with para IV certification is act of patent
infringement.
 Generic drug applicant making para IV certification must
provide notice to NDA holder and patentee if he has different
form NDA
 & should give proof of for believing that the listed patents are
invalid or not infringed.
15
ANDA Exclusivity
 The First Filer / Applicant with para IV concerning reference
listed drug is entitled to 180 days .
 During this period FDA will not approve other ANDA having
Para IV of certification of generic Version of Reference Listed
Drug.
 However in some condition the filer may forfeit his Exclusivity.
 First filer Blocks final approval of other ANDA with Para IV
certification For 180 days.
16
 Dr. Reddy’s Was the First Company to Get 180 - days
Exclusivity for marketing of Fluoxetine 40 mg capsule
 It was discovered by Eli Lilly and Company
 Brand name -Prozac
17
Patent term Extension
 This act provide patent Extension for patent covering certain
product & method subject to FDA approval
 Only one extension can be granted concerning particular
product.
 Extension given to only patent that claims
- drug Product
- method of using Drug product
- method of Mfg. Drug product
18
Patent Litigation under Act
 Time required for aspect of Litigation may affect FDA approval
process.
 The generic drug applicant cant file decretory judgment
action against NDA holder for 45 Days after notice letter
 If patentee files within 45 day, FDA may not grant final
approval of generic application for 30 months. But if not filed
within 45 day no action by FDA.
19
Benefit of Hatch-Waxman Act For
Branded Manufacturer
 Extension of Patent
 Orange book provides public notice of Patent
 Allow restoration of patent disputes.
 30 month stay on approval of generic drug (ANDA)
20
Thank You
21

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Hatch-Waxmann Act.pptx

  • 1. Hatch-Waxman Act & Amendments Presented by – Dhakane Sumeet S. JSPM’S Rajrshi Shahu College Of Pharmacy And Research M. Pharm Pharmaceutics 1
  • 2. Introduction  Also called as Drug Price Competition and Patent Term Restoration Act 1984.  This act established approval pathway for Generic drug ANDA  This act encourages manufacturer of generic drug  Enacted in 1984  Henry Waxman of California sponsored the act 2
  • 3. History  Before 1962 new drug approval was based on safety only  In 1962 Efficacy made compulsory for marketing approval.  Before this act there was no provision for patent term extension.  Generic drug companies were required to submit comprehensive NDA which was costly & Time consuming.  If any drug was covered by patent, testing could not begin until patent is expired 3
  • 4. Objectives  Reducing cost associated with approval of generic drug.  Allow early experimental use.  Motivating generic drug manufacturer.  For getting marketing approval for generic drug without conducting clinical trial.  Patent term extension. (to compensate time lost in process) 4
  • 5. General provisions- creation of section 505 (j)  This act amended federal food and Drug act and created approval process for generic drug with section 505 (j)  This Established Abbreviated NDA (ANDA )approval process.  This Act allows generic version of previously approved innovator drug without submitting NDA.  ANDA refers previously approved NDA and relies on agency's finding of safety and effectiveness of listed product. 5
  • 6. Contd.  Time required for ANDA approval depends on parts of patent protection of innovator drug.  This law established process that - applicant need to certify patent listed. - & provide notice to NDA holder and patent owner.  If patent litigation is filled it can impose 30 month stay on approval of ANDA 6
  • 7. Contd.  When applicant submit ANDA he/she must certify one of the following things under section 505(j)(2)(A)viii • Para I – This certify that patent is not filled. • Para II - This certify that patent is expired. • Para III – This certify that patent will expire on particular date. • Para IV – This certify that patent is invalid or will not be infringed by drug for which process is begun 7
  • 8. Generic drug Manufacturer Warns notice Brand manufacturer/ innovator & explains either patent is expired / invalid / or not be violated by generic version In reply Innovator can fill Patent Infringement If filled after 45 days If filled within 45 days No action by FDA No approval by FDA for 30 month if patent is Infringed After 30 month FDA will decide it should be granted or Not 8
  • 9. Amendments A) New Drug Exclusivity i) Non-patent Exclusivity 1) Orphan Drug Exclusivity  It is granted to drug that treat disease or condition which affects less than 2 lakh people in US. Or  For those it is unlikely that US sales will recoup its development cost.  Valid For 7 Years.  But only applicable for use of drug treating rare disease or condition. 9
  • 10. 2) New Chemical Entity (NCE) Exclusivity  Granted only if FDA not previously approved that NCE.  NCE prevents Generic Company from filling application for approval of generic drug for 5 years from 1st approval of NDA  Generic company may file ANDA with para IV certification 4 year after NDA approval 10
  • 11. 3) New Clinical Study Exclusivity  It is applicable when new clinical study leads new Formulation or Changed dosing regimen.  If applicant is applying through this exclusivity he/she must submit report of clinical investigation conducted, this will be essential for approval.  This is also called as Data Exclusivity.  This prohibit FDA from approving generic drug application for new dosage form or use for 3 year. 11
  • 12. 4) Pediatric Drug Exclusivity  It is applicable only when FDA request NDA holder to conduct study of drug with pediatric population  This adds the patent / marketing exclusivity for 6 month Exclusivity Type Term Orphan Drug Exclusivity 7 Year New Chemical Entity (NCE) Exclusivity 5 Year New Clinical Study Exclusivity 3 Year Pediatric Drug Exclusivity 6 Months Generic Markating 180 Days 12
  • 13. ii) Patent Exclusivity / Orange Book  NDA holder must provide FDA with Patent number & Expiration date of patent that claims - drug, API, Formulation of active ingredient or - method of using drug intermediate or . method of making drug  When FDA approves New Drug Application, FDA publishes the patent information in FDA’s approved product with therapeutic equivalence determining Publication which is known as orange book 13
  • 14. Challenging Patent Exclusivity  As already mentioned in provision.  A generic company submitting ANDA application must make one of following certification for each patent. • Para I – This certify that patent is not filled. • Para II - This certify that patent is expired. • Para III – This certify that patent will expire on particular date. • Para IV – This certify that patent is invalid or will not be infringed by drug for which process is begun 14
  • 15.  Para IV certification is potential trigger for hatch-Waxman act patent litigation  Filling application with para IV certification is act of patent infringement.  Generic drug applicant making para IV certification must provide notice to NDA holder and patentee if he has different form NDA  & should give proof of for believing that the listed patents are invalid or not infringed. 15
  • 16. ANDA Exclusivity  The First Filer / Applicant with para IV concerning reference listed drug is entitled to 180 days .  During this period FDA will not approve other ANDA having Para IV of certification of generic Version of Reference Listed Drug.  However in some condition the filer may forfeit his Exclusivity.  First filer Blocks final approval of other ANDA with Para IV certification For 180 days. 16
  • 17.  Dr. Reddy’s Was the First Company to Get 180 - days Exclusivity for marketing of Fluoxetine 40 mg capsule  It was discovered by Eli Lilly and Company  Brand name -Prozac 17
  • 18. Patent term Extension  This act provide patent Extension for patent covering certain product & method subject to FDA approval  Only one extension can be granted concerning particular product.  Extension given to only patent that claims - drug Product - method of using Drug product - method of Mfg. Drug product 18
  • 19. Patent Litigation under Act  Time required for aspect of Litigation may affect FDA approval process.  The generic drug applicant cant file decretory judgment action against NDA holder for 45 Days after notice letter  If patentee files within 45 day, FDA may not grant final approval of generic application for 30 months. But if not filed within 45 day no action by FDA. 19
  • 20. Benefit of Hatch-Waxman Act For Branded Manufacturer  Extension of Patent  Orange book provides public notice of Patent  Allow restoration of patent disputes.  30 month stay on approval of generic drug (ANDA) 20