Chapter 7: Drug Patents Flashcards
What is a patent?
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.
Pattons typically expire 20 years from the date for filing. True or false?
True
Sometimes patents, can be extended or cease early. True or false?
True
Who grants patents?
The patent and trademark office.
What is exclusivity?
Exclusive marketing rights granted by the FDA upon approval of a drug.
Orphan drug (ODE) exclusivity duration:
Seven years
New chemical entity (NCE) exclusivity duration:
Five years
“Other” exclusivity duration:
Three years for a “change” if criteria are met
Pediatric exclusivity (PED) duration:
Six months added to existing Patents/Exclusivity.
Patent challenge (PC) exclusivity duration:
180 days (this exclusivity is for ANDAs only)
When is exclusivity granted by the FDA?
Upon FDA approval of a drug product, if the statutory requirements are meant.
The generic name of the drug is the chemical or scientific name, which describes the active drug ingredients. True or false?
True
Brand names are used only for marketing purposes. True or false?
True
The FDA’s criteria for equivalency:
The drugs are safe and effective
Pharmaceutical equivalents (same amounts of active ingredients, same dosage, same route of administration and meet standards of strength, quality purity, and identity)
They are bio equivalent
They are adequately labeled
They are manufactured in compliance with FDA’s CGMP regulations
Orange book rating A:
Products for which there are no known or suspected bioequivalence problems
Orange book rating AA:
Products and conventional dosage forms with no bioequivalence problems
Orange book rating AN:
Solutions and powders
Orange book rating AO:
Injectable oil solution
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 ANDA?
Abbreviated new drug application
What is generic first to file exclusivity?
The first generic drug manufacturer to file an ANDA with the FDA on a new off patent drug receives a six month marketing exclusivity.
What are single source drug products?
There’s only one approved product available for that active ingredient and dosage form.
What are multisource drug products?
Pharmaceutically equivalent products are available from more than one manufacturer
What is the Hatch Waxman act?
Also known as the drug price competition and patent term restoration act of 1984.
Considered the most significant drug-related legislation affecting the pharmaceutical in healthcare industries since 1962.
This 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 .
What are chemical equivalents?
Multisource products, which contain essentially identical amounts of identical, active ingredients in identical dosage forms 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 which, when administered in the same amounts, will provide the same therapeutic effect as measured by the control of a symptom or disease.
What is generic substitution?
The act of dispensing, a different brand (unbranded generic product) for the product prescribed (same chemical drug, different manufactures).
What are pharmaceutical alternatives?
Drug products that have the same therapeutic affect and strength, but different 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 pharmacological or therapeutic class that can be expected to have similar therapeutic effects when administered in therapeutically equivalent doses.
