Chapter 7 Practice Quiz

What list is generally considered the most reliable source of information on therapeutically equivalent drug products?

The Blue Book

Which of the following is an Orange Book rating?

B

What differentiates exclusivity from a patent?

Exclusivity is only granted upon the drug's FDA approval.

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?

OTC

This is NOT required by the FDA's Criteria for Equivalency.

The drugs are adequately labeled.

A generic drug is ______ to the originator brand-name drug in dosage, strength, safety, and quality.

bioequivalent

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?

biological equivalents

What term denotes the dispensing of an unbranded generic product for the product prescribed?

chemical substitution

Exclusivity gives exclusive _____, is granted by the FDA, and can run concurrently with a patent or not.

marketing rights

What is the duration of a patent challenge?

180 Days

What is required of an invention for it to be worthy of patent protection?

It must be novel, useful, and not obvious.