What are the PED designations on patents and exclusivity as listed in the Orange Book?
When pediatric exclusivity is granted to a drug product, a period of 6 months exclusivity is added to all existing patents and exclusivity on all applications held by the sponsor for that active moiety. Pediatric exclusivity does not stand alone. PED is annotated in the exclusivity column and is linked to exclusivity formerly granted. In the patent column, the patent is shown twice-once with the original patent expiration date and a second time reflecting the six month period of EXCLUSIVITY that links to that particular patent. Related information can be found on the Pediatric Medicine Page and Pediatric FAQ page.
