Patents and exclusivity apply to drugs in different ways. Patents can be issued or expire at any time regardless of the drug’s approval status. Exclusivity attaches upon approval of a drug product if the statutory requirements are met. Some drugs have both patent and exclusivity protection while others have just one or neither. Patents and exclusivity may or may not run concurrently and may or may not cover the same aspects of the drug product. Patents and exclusivities that have expired are removed from the Orange Book.
