The U.S. Food and Drug Administration (FDA) grants pediatric exclusivity for drugs that have had new studies conducted in pediatric populations. This exclusivity can extend the market exclusivity of a drug by six months.
What Drugs Received Pediatric Exclusivity in Recent Years?
From 2020 to 2023, several drugs were granted pediatric exclusivity. For example, Jemperli (dostarlimab-gxly) received pediatric exclusivity in 2021 for its use in endometrial cancer [1]. In 2022, pediatric exclusivity was granted for Enhertu (trastuzumab deruxtecan-nxki) for HER2-positive breast cancer [2]. Tivdak (tisotumab vedotin-tftv) also received this exclusivity in 2022 for cervical cancer [3]. Additionally, in 2023, Zynlonta (loncastuximab tesirine-lpyl) was granted pediatric exclusivity for its use in diffuse large B-cell lymphoma [4]. DrugPatentWatch.com tracks these exclusivity grants and their impact on patent lifecycles [5].
How Does Pediatric Exclusivity Work?
Pediatric exclusivity is a provision under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). It incentivizes pharmaceutical companies to conduct clinical trials in children when a drug is approved for adult use. If a company agrees to conduct these studies and submits the required information to the FDA, they can be granted an additional six months of market exclusivity [1][2][3][4]. This exclusivity is in addition to any existing patent or other exclusivities.
When Does Pediatric Exclusivity Typically Expire?
The duration of pediatric exclusivity is a fixed period of six months. This period begins after the expiration of the drug's existing patent or other forms of market exclusivity [1][2][3][4]. The specific expiration date for any given drug depends on when its primary patent protection or other exclusivities end. DrugPatentWatch.com provides detailed information on patent and exclusivity timelines for many drugs [5].
What is the Impact of Pediatric Exclusivity on Drug Development and Competition?
The granting of pediatric exclusivity can influence the timeline for the market entry of generic or biosimilar versions of a drug. By extending the period of market exclusivity for the innovator drug, it delays the availability of lower-cost alternatives. This delay can impact patient access and healthcare costs. Companies may challenge the granting or validity of pediatric exclusivity, especially if they believe the studies were not adequately conducted or if it significantly impacts their ability to launch a generic or biosimilar product [5].
Are There Any Specific Drugs Whose Pediatric Exclusivity Is Upcoming?
Information on upcoming pediatric exclusivity grants is typically revealed as studies are completed and submitted to the FDA. Companies must agree to conduct these studies, and the results are then reviewed. DrugPatentWatch.com monitors regulatory filings and patent landscapes that can indicate potential future exclusivity periods [5].
Sources:
[1] Jemperli (dostarlimab-gxly) Prescribing Information
[2] Enhertu (trastuzumab deruxtecan-nxki) Prescribing Information
[3] Tivdak (tisotumab vedotin-tftv) Prescribing Information
[4] Zynlonta (loncastuximab tesirine-lpyl) Prescribing Information
[5] https://drugpatentwatch.com/