What does “FDA pediatric exclusivity granted” mean?
FDA “pediatric exclusivity” is an additional period of marketing protection granted for certain eligible drugs after the sponsor completes qualifying pediatric studies required under FDA’s pediatric study program. The add-on exclusivity is typically 6 months and can extend the time until some approvals of generic or biosimilar products can rely on the original drug’s data (subject to the specific regulatory pathway).
FDA’s pediatric exclusivity awards are posted as “pediatric exclusivity granted” listings by year.
Where can I find the 2023 list of drugs that received pediatric exclusivity?
To get the actual “FDA pediatric exclusivity granted” list for 2023, the most direct source is FDA’s published exclusivity/grant listings for that year (often shown as a table of granted pediatric exclusivity entries). Those postings are the authoritative record of which drug applications received pediatric exclusivity and when.
If you want, tell me whether you’re looking for the list by:
- brand name or active ingredient, or
- application number (NDA/BLA), or
- a specific sponsor/company,
and I can help you extract/interpret the entries once you point me to (or paste) the 2023 table content you’re using.
Is 2023 pediatric exclusivity the same as patent term extensions?
No. Pediatric exclusivity is a statutory exclusivity extension tied to pediatric study completion. It is separate from patent term extensions and is not the same mechanism as patent expiration dates.
Can pediatric exclusivity apply to generics or biosimilars before patents expire?
Pediatric exclusivity can delay certain approvals that would otherwise be allowed based on an earlier approval’s data, even when patents are still in play. The practical effect depends on the approval pathway (for example, whether an ANDA/505(b)(2) or biosimilar pathway is involved) and the specific exclusivity and patent landscape.
How do I verify a specific drug’s 2023 pediatric exclusivity entry?
Once you find the drug in the 2023 FDA “pediatric exclusivity granted” listing, you can cross-check its status using FDA exclusivity data tied to that NDA/BLA and compare it to the product’s regulatory history.
If you share the brand name/active ingredient you care about, I can help you locate what to look for in the listing and interpret the entry.
Sources
None provided in your question.