GENERIC DRUGS
Dr. SHASHI KIRAN MISRA
ASST. PROFESSOR
SCHOOL OF PHARMACEUTICAL SCIENCES
GENERIC DRUGS
1. A generic drug is a pharmaceutical drug that contains the same
chemical substance as a drug that was originally protected by
chemical patents
2. A generic drug is a pharmaceutical drug which is equivalent to
a brand-name product in dosage, route of administration,
strength, quality, Kinetics, and its intended use.
3. It may also refer to any drug which is marketed under its
chemical name without advertising
4. For getting the approval to market the generic drug an
abbreviated new drug application termed as ANDA is to be
submitted by the drug companies
The abbreviated new drug application (ANDA) submitted by drug
companies must show the generic medicine is the same as the
brand- name version in the following ways:
The active ingredient in the generic medicine is the same as
in the brand-name drug/innovator drug.
The generic medicine has the same strength, use indications,
form (such as a tablet or an injectable), and route of
administration (such as oral or topical).
The inactive ingredients of the generic medicine are
acceptable.
The generic medicine is manufactured under the same strict
standards as the brand-name medicine.
A generic drug application submitted to FDA for
approval must show that:
The manufacturer is capable of making the drug correctly.
The manufacturer is capable of making the drug consistently.
The “active ingredient” is the same as that of the brand.
The right amount of the active ingredient gets to the place in the body where it has
effect.
The "inactive" ingredients of the drug are safe.
The drug does not break down over time.
IMPORTANCE
Generic drug manufacturers do not have to spend extra
money for drug discovery and preclinical and clinical
trials.
Generics are available at a lower cost; they provide an
opportunity for savings in drug expenditure in a country
According to the FDA, generic drugs can cost an
estimated 85 percent less than the medicines they are
designed to copy.
• Patients can easily find generic counterparts: Patients
do not require investigating extreme to discover
choices to many popular brand name drugs.
-Stay with the course with generics: Patients are three
times
more likely to dump branded prescriptions compared
to
their generic choices, and oftentimes this neglect is
directly linked to high copy.
What are the Basic Generic Drug
Requirements?
.Same active ingredient(s)
• Same route of administration
• Same dosage form
• Same strength
• Same conditions of use
• Inactive ingredients already approved in a similar NDA
Brand Name Drug vs. Generic Drug
(NDA) Requirements (ANDA) Requirements
1. Labeling
1. Labeling
2. Pharm/Tox
2. Pharm/Tox
3. Chemistry
3. Chemistry
4. Manufacturing
4. Manufacturing
5. Controls
5. Controls
6. Microbiology
6. Microbiology
7. Inspection
7. Inspection
8. Testing
8. Testing
9. Animal Studies
9. Bioequivalence
10. Clinical Studies
11. Bioavailability
What is Bioequivalence?
DEFINITION:The property wherein two drugs with identical active ingredients
or two different dosage forms of the same drug possess similar bioavailability
and produce the same effect at the site of physiological activity.
A generic drug is considered to be bioequivalent to the brand name drug if:
The rate and extent of absorption do not show a
significant difference from the listed drug, or
The extent of absorption does not show a
significant difference and any difference in rate
is intentional or not medically significant