DRUG Presented By

M. Uzair
Aemil Fatima

PRODUCT Maryam Akram

DEVOLPMEN
T FROM Presented To
Dr. Abubakar Munir

GENERIC
 Advantages & Conclusion
Contents Introduction ANDA Process Marketing
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Advantages &
Introduction ANDA Process Marketing Conclusion
Disadvantages
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Contents Introduction ANDA Process Marketing
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Generic Drug
A Drug Product which is equal or identical to the reference drug in:

Active Ingredient Dosage Form

Indications Quality

Route of Administration Strength

 Advantages & Conclusion
Contents Introduction ANDA Process Marketing
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Generic Drug
May have different:

Inactive Ingredient

Color

Shape
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Contents Introduction ANDA Process Marketing
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Less Expensive

Have minimal effort rise for people

who are on fixed salary
WHY?

Cut the cost of health care

expenditure
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Contents Introduction ANDA Process Marketing
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450 Rs 300 Rs
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NDA Requirements ANDA Requirements

1. Labelling 1. Labelling
2. Chemistry 2. Chemistry
3. Manufacturing 3. Manufacturing
4. Controls 4. Controls
5. Microbiology 5. Microbiology
6. Inspection 6. Inspection
7. Testing 7. Testing
8. Animal Studies 8. Bioequivalence
9. Clinical Studies
10. Bioavailability
 Advantages & Conclusion
Contents Introduction ANDA Process Marketing
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Labelling

Chemistry
ANDA Requirements

Manufacturing

Controls

Microbiological Testing

Inspection

Bioequivalence
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Contents Introduction ANDA Process Marketing
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Results are prepared

& compared
Optimum
results-ANDA
05
06 approved
Chemical/micro
labeling studies 04

03 01 Drug
Filing of development
ANDA 02

Bioequivalence
studies
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Contents Introduction ANDA Process Marketing
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After expiration of patent

Patent owner weaves its rights

WHEN?

When FDA Requirements are met

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Contents Introduction ANDA Process Marketing
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Cost benefit

Easily accessible
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Contents Introduction ANDA Process Marketing
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Patient confusion

Allergic to new color, flavors

Bioequivalence studies are less accurate than

bioavailability studies.
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Contents Introduction ANDA Process Marketing
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After expiry of patent or marketing rights of patent

drug , generic drugs are marketed

They are comparable to brand drug in dosage, route

of administration, strength, indication, dosage form
and quality

Generic drug are at affordable prices with

maintaining quality
 Generic drugs registered in Pakistan
• Pharmaceutical sector of Pakistan According to the press
release issued by the “Drug Regulatory Authority of Pakistan”
(DRAP) on 26th January 2019, Pakistan has 647 actively
operating drug manufacturing licenses, and 6440 medicines
were registered in the year of 2018
 Pricing of generic drugs
Generic drugs also tend to cost less than their brand-name counterparts because
generic drug applicants do not have to repeat animal and clinical (human) studies that
were required of the brand-name medicines to demonstrate safety and effectiveness.
But after patent expiration some drugs have same price like (brand drug) Voltral 50 mg
and (generic drug) Dicloran 50 mg.

133.3 Rs. 133.3 Rs.

References
• Generic Product Development Solid Oral Dosage Forms (Chapter 1) By Leon
Shargel & Izzy Kanfer
• Pharmaceutical Development For Multisource (Generic) Pharmaceutical Products
(draft by WHO). January 2008
• ANDA Submissions — Content and Format Guidance for Industry. September 2018
• Generic Medicines As A Way To Improve Access And Affordability: A Proposed
Framework For Pakistan