Patents and exclusivity work in a similar fashion but are distinctly different from one another. Patents are granted by the U.S. 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. Exclusivity is a statutory provision and is granted to a New Drug Application (NDA) applicant if statutory requirements are met. Exclusivity was designed to promote a balance between new drug innovation and generic drug competition.
Patents and Exclusivity
Ready to Claim Your Credits?
You have attempts to pass this post-test. Take your time and review carefully before submitting.
Good luck!
Overview
Patents and exclusivity work in a similar fashion but are distinctly different from one another. Patents are granted by the U.S. 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. Exclusivity is a statutory provision and is granted to a New Drug Application (NDA) applicant if statutory requirements are met. Exclusivity was designed to promote a balance between new drug innovation and generic drug competition.
Title
Share on ReachMD
CloseProgram Chapters
Segment Chapters
Playlist:
Recommended
We’re glad to see you’re enjoying ReachMD…
but how about a more personalized experience?