Information for Healthcare Professionals (Drugs) > Patents and Exclusivity
FDA Drug Info Rounds is a series of training videos for practicing clinical and community pharmacists. Drug Info Rounds is brought to you by pharmacists in the FDA's Center for Drug Evaluation and Research (CDER), Office of Communications (OCOMM), Division of Drug Information (DDI). Pharmacists in DDI answer hundreds of questions everyday about drug products and FDA actions. Our goal is to provide important and timely drug information to pharmacists so they can help patients make better medication decisions.
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.
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