Quiz 7, Chapter 7 Flashcards
Exclusivity gives exclusive ___________, is granted by the FDA, and can run concurrently with a patent or not.
Marketing rights.
What differentiates exclusivity from a patent?
Exclusivity is only granted upon the drug’s FDA approval.
What is required of an invention for it to be worthy of patent protection?
It must be novel, useful, and not obvious.
A generic drug is ________ to the originator brand-name drug in dosage, strength, safety, and equality.
bioequivalent
The FDA’s Criteria for Equivalency requires the drugs contain identical amounts of the same inactive ingredients.
False.
A generic drug is __________ to the originator brand-name drug in dosage, strength, safety, and quality.
bioequivalent
What list is generally considered the most reliable source of information on therapeutically equivalent drug products?
“Approved Drug Products with Therapeutic Equivalence”
Which of the following is an Orange Book rating - a) AZ, b) B, c) BZ, or d) CZ?
B.
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?
Biologic equivalents.
What term denotes a drug that is identical or bioequivalent to the originator brand-name drug in dosage form, safety, strength, route, quality, performance?
Generic.
What term denotes the dispensing of an unbranded generic product for the product prescribed?
Generic substitution.
What is the duration of a patent challenge?
180 days (6 months)
