CNPR Ch. 7 Exam with Complete Solutions
Chemical Equivalents - ANSWER-Multi source products which contain essentially
identical amounts of identical active ingredients in identical dosage forms and which
meet existing physical chemical standards
Exclusivity - ANSWER-is exclusive marketing rights granted by the FDA upon approval
of a drug and can run concurrently with a patent or not
FDA's Criteria for Equivalence - ANSWER-The following criteria is required
- the drugs are approved as both safe and effective
- they are pharmaceutical equivalents i.e.
o contain identical amounts of the same active ingredients in the same dosage form and
route of administration
o they meet applicable standards of strength, quality, purity and identity
- They are bioequivalent
o Meet acceptable in-vitro standards
o If not, meet appropriate in-vivo bioequivalence standards
- They are adequately labeled
- They are manufactured in compliance with FDA's CGMP regulations
Generic drug - ANSWER-is a drug that is identical, or bioequivalent to the originator
brand-name drug in dosage form, safety, strength, route of administration, quality,
performance characteristics and intended use.
Generic Drug First-to-File Exclusivity - ANSWER-the first generic drug manufacturer to
file an ANDA with the FDA on a new off patent drug receives a 6 month marketing
exclusivity
Generic name - ANSWER-name of a drug that is the chemical or scientific name, which
describes the active drug ingredients
Generic Substitution - ANSWER-The act of dispensing a different brand (unbranded
generic product) for the product described, i.e. chemically the exact same drug entity in
the same dosage form but manufactured or distributed by different companies
Generically Equivalent Drugs - ANSWER-Drug formulations of identical composition,
with respect to the active ingredient (i.e. drugs that meet current official standards of
identity, purity, and quality of active ingredient
How long is a patent granted for? - ANSWER-Patents expire 20 years from the date of
filing.
Is there a significant quality difference between generic and brand drugs? - ANSWER-
No because generic manufacturers must demonstrate to the FDA that a generic drug
Chemical Equivalents - ANSWER-Multi source products which contain essentially
identical amounts of identical active ingredients in identical dosage forms and which
meet existing physical chemical standards
Exclusivity - ANSWER-is exclusive marketing rights granted by the FDA upon approval
of a drug and can run concurrently with a patent or not
FDA's Criteria for Equivalence - ANSWER-The following criteria is required
- the drugs are approved as both safe and effective
- they are pharmaceutical equivalents i.e.
o contain identical amounts of the same active ingredients in the same dosage form and
route of administration
o they meet applicable standards of strength, quality, purity and identity
- They are bioequivalent
o Meet acceptable in-vitro standards
o If not, meet appropriate in-vivo bioequivalence standards
- They are adequately labeled
- They are manufactured in compliance with FDA's CGMP regulations
Generic drug - ANSWER-is a drug that is identical, or bioequivalent to the originator
brand-name drug in dosage form, safety, strength, route of administration, quality,
performance characteristics and intended use.
Generic Drug First-to-File Exclusivity - ANSWER-the first generic drug manufacturer to
file an ANDA with the FDA on a new off patent drug receives a 6 month marketing
exclusivity
Generic name - ANSWER-name of a drug that is the chemical or scientific name, which
describes the active drug ingredients
Generic Substitution - ANSWER-The act of dispensing a different brand (unbranded
generic product) for the product described, i.e. chemically the exact same drug entity in
the same dosage form but manufactured or distributed by different companies
Generically Equivalent Drugs - ANSWER-Drug formulations of identical composition,
with respect to the active ingredient (i.e. drugs that meet current official standards of
identity, purity, and quality of active ingredient
How long is a patent granted for? - ANSWER-Patents expire 20 years from the date of
filing.
Is there a significant quality difference between generic and brand drugs? - ANSWER-
No because generic manufacturers must demonstrate to the FDA that a generic drug
