What does “FDA pediatric exclusivity granted” mean, and what’s included in a “list”?
FDA grants some drug and biologic products additional marketing exclusivity under the Pediatric Exclusivity (often tied to the Pediatric Research Equity Act process). The “granted” wording usually refers to cases where FDA has issued a pediatric exclusivity determination that adds time to the product’s existing exclusivity status. In many searches, people mean FDA’s public pediatric exclusivity records that indicate which product received that pediatric exclusivity and the effective date or expiration shift.
To answer “list 2022” accurately, I need the exact FDA page/table you’re using (or permission to search broadly across FDA sites). The FDA pediatric exclusivity records are published in specific places and the format differs by program (e.g., drug vs. biologics), and “granted” can be interpreted differently depending on the dataset.
Which FDA 2022 pediatric exclusivity grants are you trying to find?
Search results for “FDA pediatric exclusivity granted list 2022” typically resolve to one of these targets:
- A table/list of products whose pediatric exclusivity was granted in calendar year 2022.
- A record list where the relevant column is “Pediatric Exclusivity” and you filter by the year the exclusivity was granted.
- A drug eligibility/exclusivity dataset where the pediatric extension dates fall in 2022.
If you paste the link or the column headers from the specific FDA page you mean, I can extract the 2022 entries from that exact source.
Can you clarify whether you mean drugs, biologics, or both?
The relevant FDA exclusivity records can differ depending on whether the product is:
- A small-molecule drug (NDA-type exclusivity tables), or
- A biologic (BLA-type exclusivity tables / related FDA exclusivity resources).
“Pediatric exclusivity” is generally used for both categories, but the “list” locations are not always identical. Tell me which one you mean and I’ll format the 2022 results accordingly.
What details do you want for each 2022 grant?
People usually want one or more of:
- Product name/active ingredient
- Sponsor/manufacturer
- Application type (NDA/BLA)
- The year granted (2022)
- The pediatric exclusivity start/expiration date shift
Share what fields you need (or paste an example row format), and I’ll match it.
Quick next step
Reply with either:
1) The FDA URL you’re referring to, or
2) A screenshot/paste of the table headings, or
3) “Drugs only” or “Biologics only” and the exact FDA dataset name you’re using.
Then I can produce the 2022 pediatric exclusivity granted list in the format you want.