NAPSR CHAPTER 7 QUESTIONS AND
ANSWERS WITH VERIFIED SOLUTIONS
100% CORRECT (GRADED A+)
Q: Exclusivity gives exclusive ____ , is granted by the FDA, and can run
concurrently with a patent or not.
A: marketing rights
Q: What differentiates exclusivity from a patent?
A: Exclusivity is only granted upon the drug's FDA approval
Q: What is required of an invention for it to be worthy of patent protection?
A: It must be novel, useful and not obvious
Q: A generic drug is _____ to the originator brand-name drug in dosage,
strength, safety and quality.
A: Bioequivalent
Q: What list is generally considered the most reliable source of information on
therapeutically equivalent drug products?
A: Approved Drug Products with Therapeutic Equivalence
Q: What is the term for chemical equivalents which, when administered in the
same amounts, will provide the same biological or physiological availability as
measured by blood and urine levels?
A: Biological Equivalents
Q: What term denotes the dispensing of an unbranded generic product for the
product prescribed?
A: Generic substitution
Q: What term denotes a drug that is identical or bioequivalent to the
originator brand-name drug in dosage form, safety, strength, route, quality,
performance, characteristics and intended use?
A: Generic
ANSWERS WITH VERIFIED SOLUTIONS
100% CORRECT (GRADED A+)
Q: Exclusivity gives exclusive ____ , is granted by the FDA, and can run
concurrently with a patent or not.
A: marketing rights
Q: What differentiates exclusivity from a patent?
A: Exclusivity is only granted upon the drug's FDA approval
Q: What is required of an invention for it to be worthy of patent protection?
A: It must be novel, useful and not obvious
Q: A generic drug is _____ to the originator brand-name drug in dosage,
strength, safety and quality.
A: Bioequivalent
Q: What list is generally considered the most reliable source of information on
therapeutically equivalent drug products?
A: Approved Drug Products with Therapeutic Equivalence
Q: What is the term for chemical equivalents which, when administered in the
same amounts, will provide the same biological or physiological availability as
measured by blood and urine levels?
A: Biological Equivalents
Q: What term denotes the dispensing of an unbranded generic product for the
product prescribed?
A: Generic substitution
Q: What term denotes a drug that is identical or bioequivalent to the
originator brand-name drug in dosage form, safety, strength, route, quality,
performance, characteristics and intended use?
A: Generic
