Chapter 7 - Drug Patents Flashcards
Which U.S. department processes and grants all drug patents?
The U.S. Patent and Trademark Office.
What must a drug be to be worthy of a patent?
It must have qualities that are novel, useful, and not obvious.
What is exclusivity in regards to a patent?
Exclusive marketing rights granted by the FDA upon approval of a drug.
What is the duration of exclusivity for an orphan drug?
7 years.
Describe the names given to drugs.
Brand name (marketing purposes) and generic name (chemical or scientific name that describes the active ingredients).
ANDA
Abbreviated New Drug Application
Drug Price Competition and Patent Term Restoration Act of 1984 - Made it easier to bring generic drugs to the market by requiring the FDA only look at bioavailability studies in order to approve ANDA.
Hatch-Waxman Act
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
Act of dispensing a different brand (unbranded generic product) for the product described.
Generic Substitution
What list is generally considered the most reliable source of information on therapeutically equivalent drug products?
Approved Drug Products with Therapeutic Equivalence (Orange Book)
What differentiates exclusivity from a patent?
Exclusivity can only be granted upon FDA’s drug approval.
Duration of Exclusivity:
New Chemical Entity (NCE)
5 years
Duration of Exclusivity:
“Other” Exclusivity
3 years for a “change” if criteria are met
Duration of Exclusivity: Pediatric Exclusivity (PED)
6 months added to existing Patents/Exclusivity
Duration of Exclusivity: Patent Challenge (PC)
180 days (This is for ANDAs only)
The first generic drug manufacturer to file an ANDA with the FDA on a new off-patent drug receives a 6 month marketing exclusivity.
Generic drug first-to-file exclusivity
There is only one approved product available for that active ingredient and dosage form.
Single-source drug products
Pharmaceutically equivalent products are available from more than one manufacturer.
Multi-source drug products
Drug 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.
Pharmaceutical Alternatives
The act of dispensing a pharmaceutical alternative for the product prescribed.
Pharmaceutical substitution
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.
Therapeutic Alternatives
