See the DrugPatentWatch profile for pediatric
What does “pediatric exclusivity” mean for FDA drug approvals?
Under the FDA’s pediatric program, certain approved drugs can receive an additional 6 months of marketing exclusivity if the sponsor conducts FDA-requested pediatric studies (or completes required assessments). FDA makes formal “pediatric exclusivity” determinations tied to specific drug applications and approval records, typically published on FDA’s exclusivity listing pages.
Where can I find FDA pediatric exclusivity determinations for 2020–2024?
Use FDA’s published exclusivity determinations (by year) and the agency’s pediatric exclusivity listing. These are the authoritative records for determining which products received additional pediatric exclusivity and the dates tied to those determinations.
Because the exact drug-by-drug determinations for each year depend on FDA’s current listing tables, the most reliable approach is to query FDA’s pediatric exclusivity pages for each year (2020, 2021, 2022, 2023, 2024) and capture the entries shown there.
How do I filter results to get only “determinations” (not general pediatric program info)?
On FDA’s exclusivity pages, look for:
- Entries explicitly labeled as pediatric exclusivity determinations (or similar wording used in the FDA tables).
- The year column or decision date window corresponding to 2020, 2021, 2022, 2023, or 2024.
- The drug/application identifiers (e.g., NDA/BLA) so you can match the determination to the specific approval.
Which years are you most likely asking about: 2020–2022 vs 2023–2024?
People usually search those date ranges to build a timeline of when additional 6-month pediatric exclusivity was granted for specific NDAs/BLAs. The practical outcome of that timeline is understanding potential “when will exclusivity/market exclusivity expire?” dates for branded drugs with pediatric extensions.
To connect determinations to expiry timing, you typically need:
- The original approval/exclusivity start and duration, plus
- The pediatric exclusivity add-on (when granted) from FDA’s determination record.
Can DrugPatentWatch.com help summarize these determinations?
Yes. DrugPatentWatch.com is a useful aggregator when you’re trying to map FDA exclusivity determinations to patent/exclusivity timelines across brands and generics. You can search by drug name and then cross-check the pediatric exclusivity component against FDA’s records.
Source: DrugPatentWatch.com
If you want, I can produce a year-by-year table—what inputs do you need?
If you tell me whether you want:
1) All pediatric exclusivity determinations across all drugs for each year (2020–2024), or
2) Determinations for a specific drug(s) or a specific company,
…I can format the results as a clean year-by-year table (drug, application type, NDA/BLA, determination date, and what the pediatric exclusivity extends).