Unraveling the Exclusivity Determination for Prodrugs

One difficulty in bringing a prodrug to market is that the determination of market exclusivity for a prodrug has been evolving in the Food and Drug Administration (FDA) over the years. This process has included the interpretation and re-interpretation of regulations establishing what constitutes a prodrug for the purpose of defining a period of market exclusivity. If a prodrug is determined to be a new chemical entity, it is eligible for five years of market exclusivity. This white paper discusses this process, providing insight into the recent exclusivity reconsiderations for a number of previously approved prodrugs as well as knowledge about probable future decisions regarding prodrug exclusivity.