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CHAPTER 5: GENERIC DRUGS

Lecturer: Do Bich Hang, PhD.

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 Contents

1. Generic drugs and brand name drugs

2. International Nonproprietary Names
(INN)
3. Generic drugs approval
4. Brand versus generic medicines

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 1. Generic drugs and brand name drugs
Brand name drugs (Innovator drugs)
Drugs invented by Pharmaceutical companies and often
patented.

Generic drugs
A drug product that is comparable to brand/innovator drugs in
dosage form, strength, route of administration, quality and
performance characteristics, and intended use. It should contain
the same active ingredients as the original formulation.

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 1. Generic drugs and brand name drugs

Name of generic drugs

- Chemical substance
- Follow brand name

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 1. Generic drugs and brand name drugs
Some examples of generic drugs

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 2. International Nonproprietary
Names (INN)

• INN (International Nonproprietary Names):

- Official chemical name given to a pharmaceutical
substance as designated by the WHO.
- Purpose: ensure standard name for each chemical
substance across the world.
• United States Adopted Name (USAN)
• British Approved Name (BAN)

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 3. Generic drug approval
Generic drug approval
Generic drugs must:
- Contain the same active ingredients as the brand name
drug.
- Are identical in strength, dosage, form and route of
administration.
- Are used for the same conditions.
- Are bioequivalent
- Meet the same requirements for strength, purity and
quality.
- Are manufactured under the same strict standards of good
manufacturing practices as required for brand name
products.
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 4. Brand versus generic medicines

Switching to generic drugs

• Generic drug doesn’t mean lower quality.
• Increasing substitution of brand name drugs by
generic drugs.
• In case of “narrow therapeutic index”, should take
more care when using generic drugs.

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 4. Brand versus generic medicines

Why are brand name drugs more

expensive?
• Higher cost for investment in discovering
(research, development, marketing, etc.)
Pre-clinical tests and clinical tests (brand name
drugs) can be replaced by simple bioequivalence
studies (generic drugs).

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 -The end-

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