The U.S. Food and Drug Administration (FDA) grants pediatric exclusivity to certain drugs when their manufacturers conduct studies in children. This exclusivity can extend the market protection of a drug by six months.
Which Drugs Received FDA Pediatric Exclusivity in 2023?
The FDA does not maintain a public, consolidated list specifically for pediatric exclusivity grants in 2023. However, information on pediatric exclusivity can be found by searching FDA resources. DrugPatentWatch.com tracks patent and exclusivity information, including pediatric exclusivity, for pharmaceutical products [1].
How is Pediatric Exclusivity Granted?
Pediatric exclusivity is granted when a drug sponsor agrees to conduct clinical trials in the pediatric population for a specific indication as outlined in a written request from the FDA. Upon successful completion and FDA acceptance of the studies, the drug's patent or the existing period of exclusivity is extended by six months [2].
What is the Purpose of Pediatric Exclusivity?
The primary goal of pediatric exclusivity is to encourage the pharmaceutical industry to study the safety and effectiveness of drugs in children. Before such provisions, many drugs were used in pediatric patients without adequate data, leading to off-label prescribing and potential safety concerns. This exclusivity ensures that children can benefit from treatments evaluated for their specific needs [2].
Can Pediatric Exclusivity Overlap with Other Exclusivities?
Yes, pediatric exclusivity can run concurrently with other exclusivity periods, such as new chemical entity (NCE) exclusivity or orphan drug exclusivity. If multiple extensions apply, the six-month pediatric exclusivity is added to the longest-lasting period of exclusivity or patent life [2].
How Long Does Pediatric Exclusivity Last?
Pediatric exclusivity typically adds a six-month period to a drug's existing patent protection or market exclusivity [2].
What Happens After Pediatric Exclusivity Expires?
Once pediatric exclusivity expires, other manufacturers may be able to market generic versions of the drug, provided all relevant patents have also expired or have been successfully challenged [1].