Pharmaceutical Sales Training ACTUAL PRACTICE
EXAM QUESTIONS 2026-2027 COMPLETE
ACCURATE EXAM REAL QUESTIONS AND
CORRECT DETAILED ANSWERS WITH
RATIONALES (RELIABLE SOLUTIONS)
CURRENTLY UPDATED VERSION 2026 EDITION
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.
how long is a patent granted for?
20 years
what is the difference between patent and exclusivity?
patents are granted by the patent and trademark office anywhere along
the development lifeline of a drug and can encompass a wide range of
claims. exclusivity is exclusive marketing rights granted by the FDA upon
approval of a drug and can run concurrently with a patent or not.
How long is exclusivity granted for?
Orphan Drug- 7 years
New chemical entity- 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 ANDA's only)
,what is the difference between the generic name and the brand name?
the generic name of a drug is the chemical or scientific name which
describes the active drug ingredients and brand names are used only for
marketing purposes
is there a significant quality difference between generic and brand
drugs?
no just different names
what are the FDA's criteria for equivalence?
-the drugs are approved as both safe and effective
-they are pharmaceutical equivalents
-they are bioequivalent
-they are adequately labeled
-they are manufactured in compliance with FDA's CGMP regulations
what is the Orange book?
a list of "approved drug products with therapeutic equivalence"
what is the most reliable source for determining therapeutically
equivalent drug products?
The Orange Book
in the Orange Book rating what does A mean?
products for which there are no known or suspected bioequivalence
problems
,in the Orange Book rating what does AA mean?
products in conventional dosage forms with no bioequivalence problems
in the Orange Book rating what does AN mean?
solutions and powders
in the Orange Book rating what does AO mean?
Injectable oil solutions
in the Orange Book rating what does AP mean?
injectable aqueous solutions
in the Orange Book rating what does AT mean?
Topical products
in the Orange Book rating what does B mean?
Drug products requiring further FDA investigation and review to
determine equivalence.
The Hatch Waxman Act
aka the Drug Price Competition and Patent Term Restoration act of 1984.
made it easier to bring generic drugs to the market by requiring FDA to
only look at bioavailability studies in order to approve an ANDA.
, The agency which regulates the distribution and use of narcotics and
other controlled substances is _ _.
DEA (Drug Enforcement Agency)
The cost for all phases of R&D for drug companies are rising, with the
increase particullry acute for _____ _.
Clinical trials
The best way to deliver healthcare is through a __________ system.
Market-based
Monoclonal antibodies are created in laboratories to target the
___________ of patients to kill cancer
cancer cells
EXAM QUESTIONS 2026-2027 COMPLETE
ACCURATE EXAM REAL QUESTIONS AND
CORRECT DETAILED ANSWERS WITH
RATIONALES (RELIABLE SOLUTIONS)
CURRENTLY UPDATED VERSION 2026 EDITION
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.
how long is a patent granted for?
20 years
what is the difference between patent and exclusivity?
patents are granted by the patent and trademark office anywhere along
the development lifeline of a drug and can encompass a wide range of
claims. exclusivity is exclusive marketing rights granted by the FDA upon
approval of a drug and can run concurrently with a patent or not.
How long is exclusivity granted for?
Orphan Drug- 7 years
New chemical entity- 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 ANDA's only)
,what is the difference between the generic name and the brand name?
the generic name of a drug is the chemical or scientific name which
describes the active drug ingredients and brand names are used only for
marketing purposes
is there a significant quality difference between generic and brand
drugs?
no just different names
what are the FDA's criteria for equivalence?
-the drugs are approved as both safe and effective
-they are pharmaceutical equivalents
-they are bioequivalent
-they are adequately labeled
-they are manufactured in compliance with FDA's CGMP regulations
what is the Orange book?
a list of "approved drug products with therapeutic equivalence"
what is the most reliable source for determining therapeutically
equivalent drug products?
The Orange Book
in the Orange Book rating what does A mean?
products for which there are no known or suspected bioequivalence
problems
,in the Orange Book rating what does AA mean?
products in conventional dosage forms with no bioequivalence problems
in the Orange Book rating what does AN mean?
solutions and powders
in the Orange Book rating what does AO mean?
Injectable oil solutions
in the Orange Book rating what does AP mean?
injectable aqueous solutions
in the Orange Book rating what does AT mean?
Topical products
in the Orange Book rating what does B mean?
Drug products requiring further FDA investigation and review to
determine equivalence.
The Hatch Waxman Act
aka the Drug Price Competition and Patent Term Restoration act of 1984.
made it easier to bring generic drugs to the market by requiring FDA to
only look at bioavailability studies in order to approve an ANDA.
, The agency which regulates the distribution and use of narcotics and
other controlled substances is _ _.
DEA (Drug Enforcement Agency)
The cost for all phases of R&D for drug companies are rising, with the
increase particullry acute for _____ _.
Clinical trials
The best way to deliver healthcare is through a __________ system.
Market-based
Monoclonal antibodies are created in laboratories to target the
___________ of patients to kill cancer
cancer cells
