The Hatch-Waxman Act established in 1984 aimed to make generic drugs more available and reduce costs. It allows generic companies to file Abbreviated New Drug Applications referencing approved branded drugs to expedite approval process. The Act also provides incentives for early patent challenges of branded drugs and compensates branded companies for regulatory approval time lost from patent term. It established a 180-day market exclusivity period for first generic to challenge a patent, but loopholes exist like authorized generics that negatively impact generic competition.

1. 1
HATCH WAXMAN ACTHATCH WAXMAN ACT
Presented by,Presented by,
FARSANA PFARSANA P
SANGEETHA RSANGEETHA R
DEPT OF PHARMACEUTICSDEPT OF PHARMACEUTICS
GRACE COLLEGE OF PHARMACYGRACE COLLEGE OF PHARMACY

2. 2
• The Hatch Waxman Act (Drug Price
Competition and Patent Term
Restoration Act) was established in
1984.
• AIM:- “to make available more low
cost generic drugs”

3. 3
OBJECTIVES:-OBJECTIVES:-
• Reducing the cost associated with
the approval of a generic drug.
• Allowing early experimental use.
• Motivating the generic drug
manufactures
• Compensating the branded drugs
manufactures for the time lost from
the patent term because of the
regulatory approval
formality.

4. 4
Basic structure of the Act 1
• Orange book listing by
NDA holder
• Abbreviated New Drug
Applications
• Patent certifications by ANDA
applicants
especially paragraph IV

5. 5
PARA IV CERTIFICATIONS
After 45 days patent
holder doesn’t sue
Applicant- FDA may
Approve ANDA
After 45 days patent
holder sues the
Applicant- 30 months stay
Granted to patent
Holder.
ANDA applicant
Granted approval.
30 months stay
expired
30 months stay not
expired

6. 6
For the first
Applicant the EMR
of 180 days starts
With court’s
Decision.
Subsequent approvals
For EMR are granted
After expiry of first
Applicant’s 180 days.
If judgement’s in favour of
Patent holder FDA cannot
Approve ANDA untill patent
expiry
Judgement favouring ANDA EMR
Of 180 days begins for first
applicant
No entry occurs untill patent
expiry
First applicant enters, subsequent
Applications enter only after expiry
Of EMR for the first
Applicant.

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180-DAY EXCLUSIVITY?
Hatch-waxman amendments provide -180days
“First” generic applicant who challenges to listed
patent by filing paragraph IV certification
180 day exclusivity could be granted to more
than one applicant

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Example :Example :
180 day excluvisity granted to Ranboxy and
Watson laboratories for marketing generic
version of lipitor
Eligibility for a 180 Day exclusivityEligibility for a 180 Day exclusivity
First applicant who file a substantially complete
ANDA containing a paragraph IV certification is
eligible.
 It begins either from beginning of date of commercial
marketing of generic drug product
Or court decision finding patent invalid

9. 9
LOOPHOLES IN HATCH-WAXMAN ACT
Authorized
generics 30 month stay
Warehousing
patent
Reverse payments
citizen’s petitions

10. 10
 Pharmaceutical product
 Brand name product (approved)
 but marketed as generic drugs
AUTHORIZED GENERICS

11. 11
Authorized generics should abolished I
Loophole in hatch waxman scheme permits
introduction of AG in 180day exclusivity
periods
Successful generic challenger to the
authorized generics and its branded
sponsor
Negatively affect the generic
manufactures to challenge drug patents

12. 12
Authorized generics should abolished II
• AG may help consumers lowering
prices
• The Hatch Waxman Act is prohibit
introduction of AG equivalent to a
branded product
Directly or in directly
By an NDA holder
During the 180-day exclusivity period

13. 13
Thank youThank you