A detailed ppt on Generic drug development useful for D.pharm, B.pharm and M.pharm Students This ppt provides brief summary to "introduction to generic drug development process", "hatch-waxman act", "steps involved in generic drug development", "ANDA filing for seeking approval of generic drug".

1. GENERIC DRUG DEVELOPMENT
Presented By:
DHIRAJ NITIN SONAWANE
M. PHARM
(DEPARTMENT OF PHARMACEUTICS)
ROLL NO: MPH16
R.C.PATEL INSTITUTE OF PHARMACEUTICAL
EDUCATION AND RESEARCH, SHIRPUR
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Guided By:
DR. C. V. PARDESHI SIR
ASSOCIATE PROFESSOR
(DEPARTMENT OF PHARMACEUTICS)

2. 1) Introduction to generic drugs.
2) Comparison Between Innovator Vs
Generic Drug Products (Similarities)
3) Comparison Between Innovator Vs Generic
Drug Products (Differences)
7) Generic Drug Development Process
6) Objectives Of The Act
5) Hatch-Waxman Act And Amendments
4) Price Comparison Between Generic drug
product and brand drug product
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8) Generic Drug approval Process
9) Conclusion
10) Reference

3. According to WHO "Generic drug is a pharmaceutical
product which is usually intended to be interchangeable
with an innovator product, is manufactured without a
license from the innovator company, and is marketed
after the expiry date of the patent or other exclusive
rights".
INTRODUCTION TO GENERIC DRUGS
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4. EX- Phenytoin is the generic drug and Dilantin is the
brand name for the same drug.
 Brand drugs are the drugs which are protected by the
patent.
Generic products growth is 19% in 1984 and 50% in
2004.
INTRODUCTION TO GENERIC DRUGS
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Attributes Innovator Generic
SIMILARITIES
Availability All licensed shops All licensed shops
cGMP Yes Yes
Test standards Yes Monographs
Stability Yes Yes
Safety Yes Yes
Regulatory compliance Yes Yes
Approval time More Short
Brand name Yes Yes
Cost of manufacturing Almost same Almost same
Fig.1.1. Comparison between innovator Vs generic drug products (similarities) 5

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Attributes Innovator Generic
DIFFERENCES
Quality system Yes Personal Reference
Efficacy Yes Yes, but may not be
interchangeable
Manufacturing By innovator only By innovator or other than the
innovator
Composition Specific excipients Different excipients than the
innovator product
Price/value High Low
Packaging/ appearance Specific Different excipients than the
innovator product
Promotion responsibility Innovator Generic manufacturer and
government
Product development 12-14 Years 2-4 Years
Purity/size/strength Specific May slightly vary
Fig.1.2. Comparison between innovator Vs generic drug products (Differences)
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Price Comparison between Generic drug product & Brand drug product :
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8. HATCH-WAXMAN, 1984 ACT AND ITS
AMMENDMENTS
 It knows as “THE DRUG PRICE COMPETITION and PATENT RESTORATION ACT”
 Enacted in 1984
 Amended the patent laws
 Amended the federal food, drug and cosmetic act.
 Before 1962 new drug approval was based on safety alone.
 In 1962 proof of efficacy was made compulsory for marketing approval of a new drug.
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9. OBJECTIVES OF THE ACT
Reduce the cost associated with approval of generic drugs.
Allowing the early experimental use.
Compensating the branded drugs manufactures for the time lost from the
patent term because of the regulatory approval formality.
 Motivating the generic drug manufactures.
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10. 1 0
1. Drug
Candidate
selection
2. Candidate
drug screening
3. Concept
development
4. System
level design
5. Detail
design
6. Concept
testing
7. Business
analysis
8.
Development
of prototype
9.
Development
of technology
10 .Registratio
n
11. Launch
GENERIC DRUG DEVELOPMENT PROCESS :
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11. 1. Drug candidate selection: This phase covers
the broad selection of potential drug candidates.
2. Candidate drug screening : In this phase drug
candidates selected in the earlier phase is
carefully screened to roughly assess the potential
drug candidates.
3. Concept development: It is an exercise in
which the screened candidate drug is translated
into the product concept.
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12. 4. System-level design: This phase includes the definition of the product composition
and the division of the product into subsystems and components.
5. Detail design: A process plan is established within the production system. The output
of this phase is the control documentation for the product.
6. Concept testing: This phase is the laboratory development of a generic product. This
phase starts with experimental and accelerated stability study work, the development
based on a laboratory scale, including the (pilot) bio-equivalent-study and development
of the primary packaging.
Continue...
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13. Fig1.3: Generic Drug Development Process
Continue...
13
Generic drug
Phase IV trials
Regulatory
review
Post-Marketing
surveillance
Generic ANDA
submission
Approval by regulator Marketing begins.
7. Production ramp up : The purpose is to train the work force and to look into any
remaining problems in production process.
8.Registration: Registration is
a phase of filing of registration
dossiers at regulatory
authorities, Fig. 1.3. It finishes
when the product is registered
and the registration
documentation and marketing
authorization is obtained.

14. 9. Launch: The launch phase includes all final pre-launch activities such as the
ordering of materials, production of launch stock, ordering of raw materials,
packaging materials etc.
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Continue...

15.  The FDA's office of Generic Drugs is
responsible for reviewing the ANDA and
approving the drugs products marketing.
505(j) application, also known as an
abbreviated new drug application (ANDA), is a
submission to the FDA that shows a proposed
drug is identical to a previously approved drug
 Form FDA-356h: The main application form
for an ANDA.
 Form FDA-3674: Another form often used
in conjunction with an ANDA, which is a
"Certification of Compliance"..
GENERIC DRUG APPROVAL
PROCESS:
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Fig1.4 Drug approval process in ANDA
Yes
Yes
Yes
No
No
No
No

16.  Types of ANDA Filing :
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Continue...
1. PARA I filing – No patent ever
existed.
2. PARA II filing – Patent expired.
3. PARA III filing – Will sell once patent
get expired.
4. PARA IV filing – If existing patent is
claimed to be invalid.
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17. 1 7
Conclusion
1. Affordable Healthcare: Generic drugs provide cost-effective
alternatives to brand-name medications, improving healthcare
affordability.
2. Quality and Safety: Strict regulatory frameworks ensure that
generics meet bioequivalence, safety, and efficacy standards.
3. Increased Access: They enhance access to essential
medications, especially in underserved regions.
4. Market Competition: Generics promote competition, driving
down overall drug prices.
5. Innovation Opportunities: Ongoing research and development
in generics help improve formulations and drug delivery
methods.
6. Economic Benefits: Generics contribute to significant
healthcare cost savings for both patients and healthcare
systems.
7. Global Reach: Expanding production and distribution
networks ensure better availability
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18. REFERENCES :
1) Pharmaceutical regulatory science by Prof.(Dr.) R. Narayan Charyulu & Dr. Jobin Jose
published by Nirali Prakashan (Page no: 1.5-1.8)
2) Pharmaceutical regulatory science by Dr. Ashok A. Hajare published by Nirali
Prakashan (Page no: 1.24-1.35)
3) Mossinghoff, Gerald J. "Overview of the Hatch-Waxman Act and its impact on the drug
development process." Food & Drug LJ 54 (1999): 187.
4) Kanfer, Isadore, and Leon Shargel. "Generic Drug Product Development." DRUGS
AND THE PHARMACEUTICAL SCIENCES 201 (2010): 201.
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