Chapter 7 | Drug Patents Flashcards
What is a patent?
a patent is a 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 United States the invention described in the patent granted
Unlike other types of intellectual property, patents are only granted to inventions that fulfill exacting standards
True
To be worthy of patent protection, the invention must have qualities that are novel, useful, and not obvious
True
Patents typically expire 20 years from the date of filing
True
the general rule of thumb, the expiration date is usually no later than 21 years from priority
Patents are granted by the Patent and Trademark Office at any time during the development lifeline of a drug, and can encompass a wide range of claims
True
Exclusivity is
exclusive marketing rights granted by the FDA upon approval of a drug, which may or may not run concurrently with a patent
Different types of exclusivity have different durations:
-Orphan drug (ODE): 7 years
-New chemical entity (NCE): 5 years
-Other Exclusivity: 3 years for a change if criteria are met
-Pediatric Exclusivity (PED): 6 months added to existing patents/exclusivity
-Patent Challenge (PC): 180 days (this exclusivity is for ANDAs only)
Patents can expire before drug approval, issued after drug approval, or anywhere in between.
True
Exclusivity is granted upon FDA approval of a drug if the statutory requirements are met
True
Exclusivity is not added to the patent life
True
A generic drug is
a drug that is identical, or bioequivalent to the originator brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.
(these generically equivalent drug formulations have identical composition with respect to the active ingredient)
Generic drugs are strictly regulated by the FDA
True
Generic manufacturers must demonstrate to the FDA that a generic drug has the same medical effect as its brand name equivalent by measuring the rate and extent of drug absorption
True
FDA’S Criteria for equivalency of generic name vs brand name:
-Drugs are approved as both safe and effective
-They are pharmaceutical equivalents, meaning they 1. contain identical amounts of the same active ingredients in the same dosage form and route of administration, and 2. meet applicable standards of strength, quality, purity, and identity.
-They are bioequivalent meaning they either meet acceptable in vitro standards or meet appropriate in vivo bioequivalence standards
-They are adequately labeled
They are manufactured in compliance with FDAs CGMP regulations
FDA’s The Orange Book is
a list of “Approved Drug Products with Therapeutic Equivalence” ; it is generally considered the most reliable information source for determining therapeutically equivalent drug products.
The Orange Book Ratings:
A: products for which there are no known or suspected bioequivalence problems
AA: products in conventional dosage forms with no bioequivalence problems
AN: Solutions and powders
AO: Injectable oil solutions
AP: Injectable Aqueous solutions
AT: topical products
B: drug products requiring further FDA investigation and review to determine equivalence.
ANDA stands for:
abbreviated new drug application
generic drug first-to-file exclusivity:
the first generic drug manufacturer to file an ANDA with the FDA on a new off patent drug received a six month marketing exclusivity
single-source drug products:
there is only one approved product available for that active ingredient and dosage form
multi-source drug products:
pharmaceutically equivalent products are available from more than one manufacturer
It is considered the most significant drug-related legislation affecting the pharmaceutical and healthcare industries since 1962
the hatch-waxman act
also known as the drug price competition and paten term restoration act of 1984
The Hatch-Waxman Act made it easier to bring generic drugs to the market by requiring the FDA to only look at bioavailability studies in order to approve an ANDA.
True
It also gave protection to the research-based manufacturers by providing a 30 month automatic cooling off period once the innovator company decides to challenge an ANDA for patent infringement
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.
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
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)
