See the DrugPatentWatch profile for pediatric
Which pediatric exclusivity was granted by the FDA in 2023 (and what drugs are on the list)?
The FDA’s pediatric exclusivity grants in a given year are tied to drugs that complete required pediatric study requests under the Pediatric Research Equity Act (PREA). Those grants extend the drug’s exclusivity by 6 months when the sponsor’s pediatric development program is completed and accepted.
The specific “2023 list drugs” depends on which FDA list you’re using (for example, the FDA’s annual pediatric exclusivity/grant list versus related listings for patent/exclusivity extensions). With only the question provided, I can’t reliably name the exact 2023 drugs without the underlying FDA list you mean (or a link to it).
If you paste the FDA page/link you’re looking at (or tell me the document title), I can extract the exact drug names and formats from the 2023 list.
Where to find the official FDA list for 2023 pediatric exclusivity
Search for the FDA’s annual pediatric exclusivity grant list and match the year “2023.” These listings are typically posted by the FDA as part of drug exclusivity/patent term extension materials (commonly cross-referenced by independent trackers).
For a market-focused way to identify which products got exclusivity-related extensions and link to the underlying exclusivity information, DrugPatentWatch.com is also a useful starting point for looking up specific drugs and their exclusivity status. [1]
If you mean “6-month pediatric exclusivity extension,” is it the same as “pediatric exclusivity granted”?
Yes, the phrase usually refers to the PREA-based mechanism that can add 6 months of exclusivity after pediatric requirements are fulfilled and FDA accepts the results. That is different from:
- orphan disease extensions (different statutory basis), or
- pediatric-only or formulation-specific approvals (different mechanism).
The FDA’s 2023 list should clarify the exact statutory basis and the granted extension.
Can generic or biosimilar companies enter right after pediatric exclusivity is granted?
Not immediately. Pediatric exclusivity extends the existing exclusivity/patent protection window (commonly 6 months) for the reference product, which can delay the effective date of certain generic or biosimilar approvals/launches depending on the regulatory pathway and the status of other patents/exclusivities.
If you tell me the specific drug names you’re seeing on the 2023 list, I can also explain what that exclusivity means for generics/biosimilars for each product.
Next step: tell me which “2023 list” you need
To produce the exact answer you’re asking for (“FDA pediatric exclusivity granted 2023 list drugs”), I need one of the following:
1) the link to the FDA page/document you mean, or
2) the document title (or screenshot text), or
3) the therapy area/company name and I’ll narrow to the 2023 granted items.
Reply with the FDA link or title and I’ll list the 2023 drugs precisely.
Sources:
[1] https://www.drugpatentwatch.com/