Which FDA pediatric exclusivity awards were granted in 2020–2024?
The FDA grants pediatric exclusivity only after a drug’s sponsor completes required pediatric studies under the Pediatric Research Equity Act (PREA) or (in some cases) a pediatric study requirement tied to a marketing application. The pediatric exclusivity then adds an extra 6 months of marketing exclusivity to the underlying patent/regulatory exclusivity of the drug product [1].
However, the provided information does not include the actual list of specific products that received pediatric exclusivity in 2020, 2021, 2022, 2023, or 2024. To answer your request accurately (drug name + year), you need a source dataset such as FDA’s pediatric exclusivity approval/exclusivity-grant listings or a compiled table.
If you share a link or paste the FDA table you’re using, I can extract the drugs by year (2020–2024) and format them cleanly.
How to find the exact 2020–2024 drug list on FDA’s site
Search FDA pediatric exclusivity granted by year and use the FDA page that lists “pediatric exclusivity” awards/approvals (often under regulatory exclusivity or pediatric exclusivity listings) [1]. That listing is where you typically get the drug product identifiers and the year of exclusivity grant.
If you want, tell me whether you care about:
- only “pediatric exclusivity” (6-month extension) grants, or
- also pediatric exclusivity eligibility actions (e.g., PREA pediatric study waivers/deferrals).
Those are related but not the same.
What “pediatric exclusivity” actually means for each drug
For a qualifying NDA/BLA drug product, pediatric exclusivity adds 6 months to the existing marketing exclusivity term (or relevant exclusivity-related timeline) [1]. It is granted only after pediatric studies are completed in accordance with FDA requirements and the sponsor submits the required pediatric labeling/study information.
Quick check: are you asking for “pediatric exclusivity granted” or “pediatric studies completed”?
Many online searches mix up:
- pediatric exclusivity (a 6-month exclusivity extension grant), vs.
- PREA-required pediatric study milestones or labeling updates,
- or approvals with pediatric indications.
Your question says “granted,” which points to the 6-month exclusivity grant list, not study completion.
Next step (so I can produce the exact 2020–2024 drug names)
Send either:
1) a link to the FDA pediatric exclusivity-by-year table you’re using, or
2) the text/CSV/table contents (even screenshots are fine),
and I’ll return a year-by-year list of the drugs whose pediatric exclusivity was granted in 2020, 2021, 2022, 2023, and 2024.
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Sources
[1] https://www.fda.gov/drugs/prescription-drug-advertisements/pediatric-exclusivity