Chapter 7: Drug Patents

Question 1

What is a patent?

Answer 1

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.

Question 2

Pattons typically expire 20 years from the date for filing. True or false?

Answer 2

True

Question 3

Sometimes patents, can be extended or cease early. True or false?

Answer 3

True

Question 4

Who grants patents?

Answer 4

The patent and trademark office.

Question 5

What is exclusivity?

Answer 5

Exclusive marketing rights granted by the FDA upon approval of a drug.

Question 6

Orphan drug (ODE) exclusivity duration:

Answer 6

Seven years

Question 7

New chemical entity (NCE) exclusivity duration:

Answer 7

Five years

Question 8

“Other” exclusivity duration:

Answer 8

Three years for a “change” if criteria are met

Question 9

Pediatric exclusivity (PED) duration:

Answer 9

Six months added to existing Patents/Exclusivity.

Question 10

Patent challenge (PC) exclusivity duration:

Answer 10

180 days (this exclusivity is for ANDAs only)

Question 11

When is exclusivity granted by the FDA?

Answer 11

Upon FDA approval of a drug product, if the statutory requirements are meant.

Question 12

The generic name of the drug is the chemical or scientific name, which describes the active drug ingredients. True or false?

Answer 12

True

Question 13

Brand names are used only for marketing purposes. True or false?

Answer 13

True

Question 14

The FDA’s criteria for equivalency:

Answer 14

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

Question 15

Orange book rating A:

Answer 15

Products for which there are no known or suspected bioequivalence problems

Question 16

Orange book rating AA:

Answer 16

Products and conventional dosage forms with no bioequivalence problems

Question 17

Orange book rating AN:

Answer 17

Solutions and powders

Question 18

Orange book rating AO:

Answer 18

Injectable oil solution

Question 19

Orange book rating AP:

Answer 19

Injectable aqueous solutions

Question 20

Orange book rating AT:

Answer 20

Topical products

Question 21

Orange book rating B:

Answer 21

Drug products requiring further FDA investigation and review to determine equivalence

Question 22

What is ANDA?

Answer 22

Abbreviated new drug application

Question 23

What is generic first to file exclusivity?

Answer 23

The first generic drug manufacturer to file an ANDA with the FDA on a new off patent drug receives a six month marketing exclusivity.

Question 24

What are single source drug products?

Answer 24

There’s only one approved product available for that active ingredient and dosage form.

Question 25

What are multisource drug products?

Answer 25

Pharmaceutically equivalent products are available from more than one manufacturer

Question 26

What is the Hatch Waxman act?

Answer 26

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 .

Question 27

What are chemical equivalents?

Answer 27

Multisource products, which contain essentially identical amounts of identical, active ingredients in identical dosage forms which meet existing physical chemical standards.

Question 28

What are biological equivalents?

Answer 28

Chemical equivalents which, when administered in the same amounts, will provide the same biological or physiological availability as measured by blood and urine levels.

Question 29

What are therapeutic equivalents?

Answer 29

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.

Question 30

What is generic substitution?

Answer 30

The act of dispensing, a different brand (unbranded generic product) for the product prescribed (same chemical drug, different manufactures).

Question 31

What are pharmaceutical alternatives?

Answer 31

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.

Question 32

What is pharmaceutical substitution?

Answer 32

The act of dispensing, a pharmaceutical alternative for the product prescribed.

Question 33

What are therapeutic alternatives?

Answer 33

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.