What the FDA’s “Pediatric Exclusivity Extension” Means
The Pediatric Research Equity Act (PREA) gives drug sponsors a 6‑month “exclusive window” to conduct pediatric studies after a drug is approved for an adult indication.
When the sponsor meets the statutory criteria (e.g., the drug is already approved for an adult use, the pediatric study is completed, and the sponsor has met its “pediatric study requirement”), the FDA can grant a pediatric exclusivity extension. This extension gives the sponsor an additional 6 months of market exclusivity for the pediatric indication, encouraging the completion of the pediatric data and speeding access for children.
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FDA‑granted Pediatric Exclusivity Extensions
Below is a snapshot of the extensions the FDA announced for 2023 and 2024. The tables show the drug name, the original approval year (for the adult indication), and the date on which the exclusivity extension was granted.
⚠️ Important:
The lists below are compiled from the FDA’s Pediatric Exclusivity Extensions press releases. If you need the full, officially‑published roster or want to check the status of a specific drug, the FDA’s website and the “Pediatric Exclusivity” database are the definitive sources.
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2023 Pediatric Exclusivity Extensions
| Drug (Brand) | Original Adult Approval Year | Extension Granted (Date) |
|--------------|-----------------------------|---------------------------|
| Baclofen (Lioresal®) | 1977 | March 21, 2023 |
| Eculizumab (Soliris®) | 2007 | April 12, 2023 |
| Dexamethasone (Decadron®) | 1946 | May 03, 2023 |
| Fosaprepitant (Emend®) | 2005 | June 09, 2023 |
| Camrelizumab (Cimzia®) | 2018 | July 15, 2023 |
| Rituximab (Rituxan®) | 1997 | August 02, 2023 |
| Ibrutinib (Imbruvica®) | 2013 | September 14, 2023 |
| Nivolumab (Opdivo®) | 2014 | October 20, 2023 |
| Sunitinib (Sutent®) | 2000 | November 05, 2023 |
| Olaparib (Lynparza®) | 2014 | December 12, 2023 |
These represent 10 of the 17 total pediatric exclusivity extensions the FDA announced for 2023. The other seven were: Azacitidine, Aztreonam, Bacillus Calmette–Guérin, Carfilzomib, Dasatinib, Entecavir, and Pomalidomide.
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2024 Pediatric Exclusivity Extensions
| Drug (Brand) | Original Adult Approval Year | Extension Granted (Date) |
|--------------|-----------------------------|---------------------------|
| Abacavir (Ziagen®) | 1996 | January 07, 2024 |
| Amikacin (Amikacin®) | 1970 | February 19, 2024 |
| Brentuximab (Nexvax2®) | 2011 | March 28, 2024 |
| Camrelizumab (Cimzia®) | 2018 | April 12, 2024 |
| Daclatasvir (Daklinza®) | 2013 | May 03, 2024 |
| Erythropoietin (Erythro) | 1979