Where can you find the FDA Orange Book pediatric exclusivity list?
The FDA’s Orange Book (Drugs@FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations”) is the main public reference that tracks regulatory exclusivities tied to approved drug products, including pediatric exclusivity. Each drug product entry can include whether pediatric exclusivity has been granted and the relevant timing.
What does “pediatric exclusivity” mean on the Orange Book?
On the Orange Book, pediatric exclusivity refers to an added period of market protection for certain drugs when pediatric study requirements are met under the relevant pediatric programs. When granted, it can extend the period during which generic and other competitors may be blocked from relying on the original drug’s approval pathway.
How is the pediatric exclusivity shown in Orange Book records?
For a given listed product, the Orange Book record shows exclusivity-related information alongside other regulatory data. Users typically look for:
- The type of exclusivity (including pediatric exclusivity when applicable)
- The start/end timing (which drives when exclusivity protection ends)
Because Orange Book entries are product-specific, you usually have to search by active ingredient + dosage form/strength + manufacturer to see whether pediatric exclusivity applies to that specific listing.
Can you look up pediatric exclusivity for a specific drug?
Yes. The practical workflow is:
1. Search the Orange Book for the drug’s active ingredient.
2. Select the exact product listing (manufacturer/dosage form/strength).
3. Check the listing’s exclusivity fields for pediatric exclusivity and dates.
Is there a separate “pediatric exclusivity list” page?
FDA does maintain pediatric-related program information outside the Orange Book, but the most commonly used “list” for exclusivity status at the product level is the Orange Book listing itself, because it ties exclusivity to specific NDA/strength/formulations.
Want a third-party compiled list?
If you want something easier to scan than per-drug Orange Book lookups, DrugPatentWatch.com often compiles exclusivity/patent and regulatory-protection timelines for drugs, which can help you find when pediatric exclusivity may extend protection. You can browse their coverage here: https://www.drugpatentwatch.com/
Sources
- DrugPatentWatch – homepage