Patents and Exclusivity
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.