Medicinal Chemistry Final Exam Test
Bank With 100% Correct Detailed
Answers 2025.
What are the benefits of monoclonal antibodies? - Answer - Makes drugs for certain diseases
more effective
- reduces side effects,
- more precise than other treatments,
- can be made in large batches
- monoclonal antibody quality is standard for all batches making therapy and diagnostics easier
Patents
- granted by
- protects
- length
- prevents
- claim range - Answer - US patent and trademark office
- protects drug sponsors' investments
- 20 years
- prevents other manufacturers from entering market with the same product
-wide
Drug manufactorors can file for a patent when? - Answer at any time during the drug's lifetime
Exlusivity
- granted
- refers to and needs? - Answer - FDA
- exclusive marketing rights that the FDA gives a company after approval of an NDA (new drug
approval)
, Why are there patents and exclisivty? - Answer to promote a balance between new drug
innovation and generic drug competition
Exclusivity:
- orphan drugs
- new chemicals
- "other" - Answer - 7 years
- 5 years
- 3 years for a change
Exclusivity period with added 'change'
- pediatric - Answer - add 6 months
Patent challenge exclusivity
- granted for?
- applies to? - Answer - 180 days
- only to abbreviated new drug applications (ANDAs)
Drugs can have more than one protection (exclusivity). True or false? - Answer true, can have
both, one or none
FDA includes only what type of patent and exclusivity information? when is it updated? -
Answer active and non-expired
- patent = daily
- exclusivity = monthly
What diseases/conditions can monoclonal antibodies be used to treat? - Answer Cancer,
organ transplant rejection,
inflammatory and autoimmune diseases (ex. allergies),
infections (ex. COVID-19),
osteoporosis,
eye conditions,
Bank With 100% Correct Detailed
Answers 2025.
What are the benefits of monoclonal antibodies? - Answer - Makes drugs for certain diseases
more effective
- reduces side effects,
- more precise than other treatments,
- can be made in large batches
- monoclonal antibody quality is standard for all batches making therapy and diagnostics easier
Patents
- granted by
- protects
- length
- prevents
- claim range - Answer - US patent and trademark office
- protects drug sponsors' investments
- 20 years
- prevents other manufacturers from entering market with the same product
-wide
Drug manufactorors can file for a patent when? - Answer at any time during the drug's lifetime
Exlusivity
- granted
- refers to and needs? - Answer - FDA
- exclusive marketing rights that the FDA gives a company after approval of an NDA (new drug
approval)
, Why are there patents and exclisivty? - Answer to promote a balance between new drug
innovation and generic drug competition
Exclusivity:
- orphan drugs
- new chemicals
- "other" - Answer - 7 years
- 5 years
- 3 years for a change
Exclusivity period with added 'change'
- pediatric - Answer - add 6 months
Patent challenge exclusivity
- granted for?
- applies to? - Answer - 180 days
- only to abbreviated new drug applications (ANDAs)
Drugs can have more than one protection (exclusivity). True or false? - Answer true, can have
both, one or none
FDA includes only what type of patent and exclusivity information? when is it updated? -
Answer active and non-expired
- patent = daily
- exclusivity = monthly
What diseases/conditions can monoclonal antibodies be used to treat? - Answer Cancer,
organ transplant rejection,
inflammatory and autoimmune diseases (ex. allergies),
infections (ex. COVID-19),
osteoporosis,
eye conditions,
