Raptor Pharmaceutical Corp. has announced that the Office of Orphan Product Development at the Food and Drug Administration (FDA) granted Raptor orphan drug exclusivity for PROCYSBI(TM) (cysteamine bitartrate) delayed-release capsules for the management of nephropathic cystinosis patients age six and older. The exclusivity period began on the date of FDA approval, April 30, 2013, and lasts seven years subject to certain exceptions.
“This decision was the outcome of a productive and cooperative process with the FDA. We believe the issuance of orphan drug exclusivity highlights an appreciation that PROCYSBI is an important new therapeutic option for nephropathic cystinosis patients,” stated Thomas E. Daley, chief business officer of Raptor. “The exclusivity also adds incremental protection alongside our issued patents listed in the FDA’s Orange Book with expirations in 2027.”