ANDA for generic drug ways and means US registration for foreign drug

1. ANDA for generic drug ways & means of US
registration for foreign drug
Submitted by: Submitted to :
Sishant Rav Divya Dr. Hafsa Ahmad
M.Pharm First Year ( Pharmaceutics )
BBAU Lucknow
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2. Contents
 Introduction
 Basic generic drug requirement
 Objective of ANDA
 Innovator Vs. Generic
 Comparson between NDA & ANDA
 Generic drug approval
 Hatch-Waxman act 1984
 General provision of this act
 Broad outline for ANDA
 Information required for filing ANDA
 Patent Certification
 The Orange Book
 Review of ANDA
 References 2

3. DEFINITION of 'Abbreviated New Drug
Application (ANDA)'
 A written request to the U.S. Food and Drug Administration
(FDA’s CDER) office of generic drug, to manufacture and market
a generic drug in the United States.
 Abbreviated New Drug Applications are “abbreviated” since they
do not require the applicant to conduct clinical trials and require
less information than a New Drug Application.
 If an ANDA is approved, the generic drug will be listed in the
Orange Book, which lists all medicines the FDA has found to be
safe and effective.
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4. Basic Generic Drug Requirements Are
 Same active ingredient
 Same route of administration
 Same dosage form
 Same strength
 Same condition for uses
 Inactive ingredient already approved in similar NDA
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5. Main objective of ANDA
 To reduce the price of drug.
 To reduce the time development.
 To increase the bioavailability.
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6. Innovator & Generic
S.N. Parameters Innovator (Brand ) Generic (Chemical )
1 Active ingredient Same Same
2 Safety & Efficacy Same Same
3 Performance/standar
ds
Same Same
4 Cost More expensive Less Expensive
5 FDA inspection of
manufacturing
process
Yes Yes
6 FDA received report
of adverse reaction
Yes Yes
7 FDA received drug
labelling
Yes Yes
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7. Comparison between NDA and ANDA
S.No.
NDA ANDA
1 Application for New drug Application for Generic Drug
2 Take long time ( 12-15 Yrs. ) Take less time ( 1-2 Yrs. )
3 More Expenditure of money Comparatively less
4 Cost of drug more Cost of drug less
5 Non-clinical & clinical study are
essential
Both are not essential
6 Bioavailability & Bioequivalence
studies are essential
Only Bioequivalence study essential
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8. Generic Drug Approval
 In 1970 FDA established the ANDA For review and
approval of generic version.
 Before 1978 generic product applicant were required to
submit the complete safety & efficacy through Clinical
Trial.
 Post 1978 generic product applicant were required to
published report of such trial
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9. Hatch-Waxman Act 1984
 Hatch-Waxman commonly known as “Drug Price
Completion & Patent Term restoration Act 1984
 This act dealing with approval of Generic drug
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10. General provision of the act
 Maintaining list of patent
 Only bioequivalence study required
 No need clinical trial
 Para-I,II,III and IV certification
 Bolar Provision
 Data exclusive period for new molecule entities
 Extension of the original patent term
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11. Broad outline for ANDA
Product must meet appropriate standards of
 Identity.
 Strength.
 Quality and
 Purity
 Efficacy and safety should be equivalent to brand product already
established
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12. Information required for filing ANDA
 Product’s formulation
 Manufacturer’s procedure
 Control procedure
 Testing
 Facilities
 Dissolution profile
 Labelling
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13. Patent Certification
 While filling an ANDA, the generic manufacturer is
required to one of the following four certification
 The subject of the reference brand name listed in the
ORANGE BOOK
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14. Certification
 Para I certificate:
There is no patent for the drug listed in the orange book
 Para II certificate:
Patent is listed but expired
 Para III certification :
Patent is listed . Is valid but the generic wants approval to market the drug once
the pertinent patent expires
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15. Certification
 Para IV certificate:
Is the most critical of all and gives to almost all the anti-competitive practices
associated with the Hatch-Waxman amendments of the EED and C act
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16. The Orange Book
 The publication Approved Drug Products with Therapeutic Equivalence
Evaluations (commonly known as the Orange Book) identifies drug products
approved on the basis of safety and effectiveness by the Food and Drug
Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the
Act) and related patent and exclusivity information. For more information on
the Orange Book including its history,
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17. 17
Review of
ANDA

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19. Reference
 www.fda.gov
 www.ftc.gov/be/v990016.shtm
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