Chapter 7 - Drug Patents

Question 1

Which U.S. department processes and grants all drug patents?

Answer 1

The U.S. Patent and Trademark Office.

Question 2

What must a drug be to be worthy of a patent?

Answer 2

It must have qualities that are novel, useful, and not obvious.

Question 3

What is exclusivity in regards to a patent?

Answer 3

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

Question 4

What is the duration of exclusivity for an orphan drug?

Answer 4

7 years.

Question 5

Describe the names given to drugs.

Answer 5

Brand name (marketing purposes) and generic name (chemical or scientific name that describes the active ingredients).

Question 6

ANDA

Answer 6

Abbreviated New Drug Application

Question 7

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.

Answer 7

Hatch-Waxman Act

Question 8

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

Answer 8

Biologic Equivalents

Question 9

Act of dispensing a different brand (unbranded generic product) for the product described.

Answer 9

Generic Substitution

Question 10

What list is generally considered the most reliable source of information on therapeutically equivalent drug products?

Answer 10

Approved Drug Products with Therapeutic Equivalence (Orange Book)

Question 11

What differentiates exclusivity from a patent?

Answer 11

Exclusivity can only be granted upon FDA’s drug approval.

Question 12

Duration of Exclusivity:

New Chemical Entity (NCE)

Answer 12

5 years

Question 13

Duration of Exclusivity:

“Other” Exclusivity

Answer 13

3 years for a “change” if criteria are met

Question 14

Duration of Exclusivity:
Pediatric Exclusivity (PED)

Answer 14

6 months added to existing Patents/Exclusivity

Question 15

Duration of Exclusivity:
Patent Challenge (PC)

Answer 15

180 days (This is for ANDAs only)

Question 16

The first generic drug manufacturer to file an ANDA with the FDA on a new off-patent drug receives a 6 month marketing exclusivity.

Answer 16

Generic drug first-to-file exclusivity

Question 17

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

Answer 17

Single-source drug products

Question 18

Pharmaceutically equivalent products are available from more than one manufacturer.

Answer 18

Multi-source drug products

Question 19

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.

Answer 19

Pharmaceutical Alternatives

Question 20

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

Answer 20

Pharmaceutical substitution

Question 21

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.

Answer 21

Therapeutic Alternatives