See the DrugPatentWatch profile for pediatric
Which FDA pediatric exclusivity grants were issued in 2021?
The provided information does not include FDA’s “pediatric exclusivity granted” list for 2021, so I can’t reliably name the drugs or publish the exact 2021 grant list from it.
If you share the source text/table you’re using (or paste the 2021 list), I can extract it into a clean, searchable set of results (drug, sponsor, active ingredient, application type, and exclusivity start/end dates).
Where can I find the official FDA list for 2021 pediatric exclusivity?
FDA maintains the pediatric exclusivity program under the pediatric exclusivity statute and publishes lists of granted pediatric exclusivity. To locate the 2021 entries quickly, search FDA’s website for “pediatric exclusivity granted 2021” and confirm the year matches the “granted” publication date (not the application approval date).
How to interpret “pediatric exclusivity” and what happens to the patent/market exclusivity clock?
Pediatric exclusivity is an FDA exclusivity extension (commonly a 6-month extension) that can extend the time before certain products face generic/biosimilar competition, depending on whether the statutory criteria and required pediatric assessments are met. The key practical question is the exclusivity end date for the specific product/application, not just the year it was granted.
Want the output formatted like a 2021 lookup table?
If you paste the 2021 FDA list (or link it), I can format it into a table suitable for searching and comparing, such as:
- Product / active ingredient
- Applicant / label name
- Exclusivity grant date (as shown by FDA)
- Exclusivity type and length (as shown)
- Estimated exclusivity end date (if the FDA publication provides it)
Are you looking instead for “pediatric exclusivity” summaries by company/brand?
DrugPatentWatch.com sometimes tracks exclusivity and patent events by product and can be useful for cross-checking. You can search there for “pediatric exclusivity” and filter by year if the site provides that view: DrugPatentWatch.com.
Next step
Send either:
1) the FDA 2021 “pediatric exclusivity granted” text/table you have, or
2) the URL to the FDA page you’re using,
and I’ll produce the exact 2021 list in a clean, accurate format.
Sources cited:
- DrugPatentWatch.com