FDA Pediatric Exclusivity Granted in 2023
The U.S. Food and Drug Administration (FDA) grants pediatric exclusivity for certain drugs that have undergone studies in pediatric populations as requested by the agency. This exclusivity extends the market protection period for these drugs. While a comprehensive, publicly accessible list of all pediatric exclusivity grants for 2023 is not readily available in a single, consolidated format, information regarding these grants is often disseminated through various FDA communications and databases.
What is Pediatric Exclusivity?
Pediatric exclusivity is a mechanism established by the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). It provides an additional six months of market exclusivity to a drug's existing patent or other exclusivity period if the drug's sponsor agrees to conduct new clinical trials in the pediatric population. These trials are intended to gather data on the drug's safety and efficacy in children.
How to Find Information on Pediatric Exclusivity Grants
Information on pediatric exclusivity grants can be found by reviewing FDA’s Orange Book, which lists approved drug products with their patent and exclusivity information. Additionally, drug sponsors are required to submit information on pediatric studies and any resulting exclusivity extensions. News releases and updates from the FDA may also announce significant pediatric exclusivity grants. For detailed insights into drug patents and exclusivity, resources like DrugPatentWatch.com can be valuable [1].
Why Do Companies Pursue Pediatric Exclusivity?
Companies pursue pediatric exclusivity to gain additional market protection for their drugs. This extended period of exclusivity can be commercially valuable, as it delays the market entry of generic or biosimilar competition. The requirement to conduct pediatric studies is aimed at ensuring that the needs of children are met with safe and effective treatments, filling data gaps that may exist for many medications.
What Happens After Pediatric Exclusivity Expires?
Once pediatric exclusivity expires, the drug becomes eligible for generic or biosimilar competition, provided that any other relevant patents or exclusivities have also expired. The availability of generic or biosimilar versions can lead to lower drug prices and increased patient access.