Data exclusivity refers to the period during which the data of the original marketing authorisation holder is protected. It is the time during which another company cannot use the originator™s data in support of another marketing authorisation application, i.e.: generics, hybrids, biosimilars. Therefore, competent authorities may not accept such an application during this period of time. In Europe, this protection period lasts for a minimum of eight years and is intended to incentivise innovation.
