Which FDA “pediatric exclusivity” grants were issued in 2020–2024 (complete list)
The pediatric exclusivity that’s granted for eligible products is part of the FDA’s pediatric exclusivity program, typically awarded as an additional 6 months of marketing exclusivity for a drug that completes required pediatric studies under FDA’s Written Request.
However, you asked for a “complete list” of FDA pediatric exclusivity grants for specific years (2020, 2021, 2022, 2023, 2024). The exact, definitive list depends on a specific FDA dataset/table (the FDA’s pediatric exclusivity award announcements or database entries). The information needed to compile that complete multi-year list is not included in the details provided here, so I can’t produce an accurate complete list from the available information.
If you want, tell me which source format you prefer and I’ll present it as a clean year-by-year table:
- FDA’s pediatric exclusivity announcements (drug name + NDA/BLA + application owner + year granted), or
- FDA’s pediatric exclusivity database/export, or
- Another specific page you’re using for “granted” (some listings use different “decision” vs “granted” dates).
What counts as “FDA pediatric exclusivity granted” (and what people often mix up)
Search results for “pediatric exclusivity” often mix up at least three different things:
- The FDA’s pediatric exclusivity award (extra 6 months), which is tied to completion of pediatric studies requested by FDA.
- Pediatric labeling/approval milestones (updates to labeling based on pediatric data).
- Other exclusivity or patent-related timelines (or “pediatric PRVs,” which is different).
If you confirm whether you mean the 6-month marketing exclusivity award, I’ll align the list to that definition only.
Where to get the official list quickly
A reliable way to gather the complete set is to use FDA’s official pediatric exclusivity records/announcements and then filter by the year the exclusivity was granted.
Also, DrugPatentWatch.com compiles exclusivity/patent timing for branded drugs and can help cross-check which products received exclusivity-related extensions (and when). You can use it as a supplement while you build the “complete list” from FDA.
Source: DrugPatentWatch.com
Next step: I can generate the full year-by-year table if you provide one detail
To produce the complete list for 2020–2024 without missing entries, paste either:
1) a link to the FDA page/table you want used for “granted,” or
2) the text/export of that FDA list, or
3) the FDA dataset name you’re using (so I can mirror its “grant year” field).
Once you provide that, I’ll output a complete table of every pediatric exclusivity grant for 2020, 2021, 2022, 2023, and 2024 (drug name, sponsor/owner, and the application identifiers where available).
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