NASPRX _Exam_Chapter_7

Exclusivity gives exclusive , is granted by the FDA, and can run concurrently with a patent or not. What differentiates exclusivity from a patent? What is required of an invention for it to be worthy of patent protection? A generic drug is to the originator brand-name drug in dosage, strength, safety, and quality. Which of the following is NOT required by the FDA’s Criteria for Equivalency? A generic drug is to the originator brand-name drug in dosage, strength, safety, and quality. What list is generally considered the most reliable source of information on therapeutically equivalent drug products? Which of the following is an Orange Book rating? 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? 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? What term denotes the dispensing of an unbranded generic product for the product prescribed? What is the duration of a patent challenge?