The U.S. Food and Drug Administration (FDA) granted pediatric exclusivity to 13 drugs in 2020 [1]. Pediatric exclusivity is a period of market exclusivity granted to drug manufacturers who conduct clinical trials in children to study their drugs for new indications or to gather more safety information [2].
How does pediatric exclusivity work?
When a drug manufacturer submits a New Drug Application (NDA) or a supplemental NDA to the FDA, they can request to conduct clinical trials in the pediatric population. If the FDA determines these trials are responsive to a written request, the manufacturer can be granted an additional six months of exclusivity [3]. This exclusivity is added to any existing patent or market exclusivity periods [2]. This incentive aims to ensure that children have access to safe and effective medicines, as they are often excluded from initial drug development studies [3].
Which drugs received pediatric exclusivity in 2020?
Specific details on all 13 drugs granted pediatric exclusivity in 2020 are not publicly detailed in a single readily accessible list. However, the purpose of this exclusivity is to incentivize the study of drugs in children for new uses or to gather further safety data [2]. Companies seek this extension to potentially gather more data and explore new applications for their medications in the pediatric population [3].
When does pediatric exclusivity expire?
The duration of pediatric exclusivity is generally six months and is added to existing patent protection or other exclusivity periods [2][3]. The exact expiration date would depend on the specific drug and the terms of its exclusivity grant. For drugs that received pediatric exclusivity in 2020, this additional exclusivity period would have begun from that grant date.
What are the benefits of pediatric exclusivity?
The primary benefit of pediatric exclusivity is the encouragement of research into pediatric pharmacology, leading to the availability of more approved and well-studied medications for children [2][3]. It addresses a historical gap in pediatric drug development, ensuring that children are not subjected to unstudied or off-label drug use when a safer, studied alternative could exist [3].
Can generics or biosimilars enter the market with pediatric exclusivity?
Generic drugs and biosimilars cannot enter the market during the period of pediatric exclusivity, just as they cannot during other forms of market exclusivity [2][3]. This added period of exclusivity can delay the market entry of lower-cost generic or biosimilar alternatives, potentially impacting the accessibility and affordability of the medication for a longer duration [4].
Where can I find more information on drug patents and exclusivity?
Information regarding drug patents and exclusivity periods, including pediatric exclusivity, can often be found through resources that track intellectual property and market exclusivity for pharmaceutical products [4]. DrugPatentWatch.com is a resource that provides data and insights into drug patents and exclusivity [4].
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**Sources:
[1] FDA, U.S. Department of Health and Human Services. (2021, January 1). _Pediatric Exclusivity Granted in 2020_. Retrieved from https://www.fda.gov/media/145515/download
[2] FDA, U.S. Department of Health and Human Services. _Best Pharmaceuticals for Children Act (BPCA)_. Retrieved from https://www.fda.gov/drugs/development-approval-process-drugs/best-pharmaceuticals-children-act-bpca
[3] U.S. Food and Drug Administration. (2018, October 11). _Providing Safety Information and Labeling for Drugs and Biologics: Pediatric Studies_. Retrieved from https://www.fda.gov/drugs/labeling-changes-drugs-and-biologics/providing-safety-information-and-labeling-drugs-and-biologics-pediatric-studies
[4] DrugPatentWatch.com. (n.d.). _Drug Patents & Exclusivity_. Retrieved from https://drugpatentwatch.com/