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CNPR Certification

Chapter 7

QuestionAnswer
What is a patent? Form of personal property that provides the owner with the right to exclude others from making, using, selling, offering for sale, or importing into the US the invention described in the patent granted.
Patents are applied for with, and granted by, the ____ _______ ___ __________ ______. US Patent and Trademark Office.
What is the duration of a patent? 20 years.
True or false: Patents may cease before the normal expiration date. True: A variety of reasons non-working of invention, nonpayment of renewal fees.
What is it called with a patent reaches the end of its term? It is said to be "expired."
How long is the exclusivity duration for Orphan Drugs (ODE)? 7 years
How long is the exclusivity duration for New Chemical Entity (NCE)? 5 years
How long is the exclusivity duration for "other" exclusivity? 3 years for a "change" if criteria are met.
How long is the exclusivity duration for Pediatric Exclusivity (PED)? 6 months added to existing patents/exclusivity
How long is the exclusivity duration for Patent Challenge (PC)? 180 Days (this is for ANDA's only)
T or F: Patents and exclusivity may or may not run concurrently and may or may not encompass the same claims. True
What are the FDA's Criteria for Equivalency for drugs? 1)Safe and effective 2)Pharmaceutical equivalents 3)They are bioequivalent 4)They are adequately labeled 5)They are manufactured in compliance with FDA's CGMP regulations.
What book is a list of "Approved Drug Products with Therapeutic Equivalence?" The Orange Book
Orange Book Rating: A Products for which there are no known or suspected bioequivalence problems
Orange Book Rating: AA Products in conventional dosage form with no bioequivalence problems.
Orange Book Rating: AN Solutions and Powders
Orange Book Rating: AO Injectable Oil Solutions
Orange Book Rating: AP Injectable Aqueous Solutions
Orange Book Rating: AT Topical Products
Orange Book Rating: B: Drug products requiring further FDA investigation and review to determine equivalence.
What is a ANDA? Abbreviated new drug application
How long does a brand name company have to file a suit after a generic company files an ANDA? 45 days
True or false: The more patents that are listed in The Orange Book, the more chances the brand name company has to sue.
What is Generic Drug first-to-file exclusivity? The first generic drug manufacturer to file an ANDA with the FDA on a new off-patent drug receives a 6 month marketing exclusivity.
What are Single-Source drug products? There is only one approved product available for that active ingredient and dosage form.
What is multi-source drug products? Pharmaceutically equivalent products are available for that active ingredient dosage form.
What is another name for the Drug Price Competition and Patent Term Restoration Act of 1984? The Hatch-Waxman Act
What is the formal name of the Hatch-Waxman Act of 1984? aka H-W Act Drug Price Competition and Patent Term Restoration Act of 1984.
What are Chemical Equivalents? Multi-source products which contain essentially identical amounts of identical active ingredients in identical dosage forms and which meet existing physical chemical standards.
What are Biological Equivalents? 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 are therapeutic equivalents? Chemical equivalents, when administered in the same amounts, will provide the same therapeutic effect as measured by the control of a symptom or disease.
What is a generic substitution? The act of dispensing a different brand for the product prescribed.
What are pharmaceutical alternatives? Drugs products that have the same therapeutic effect and strength but differ in the salt, ester, or dosage form and are administered by the same route.
What is pharmaceutical substitution? The act of dispensing a pharmaceutical alternative for the product prescribed.
What are therapeutic alternatives? Drug products containing different therapeutic moieties but of the same pharmalogical or therapeutic class that can be expected to have similar therapeutic effects when administered in therapeutically equivalent doses.
Created by: dgvoss
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