What does “pediatric exclusivity” mean on the FDA Orange Book?
In the U.S., “pediatric exclusivity” is a marketing exclusivity that can extend the time a manufacturer has to sell a drug without generic competition. It is tied to whether the drug’s sponsor submits pediatric study results under FDA’s pediatric study requirements and related programs.
How can pediatric exclusivity show up in the FDA Orange Book?
On the FDA’s Orange Book product listings, pediatric exclusivity—when applicable—can appear as an exclusivity type with an associated end date for the listed active ingredient(s) and dosage form/strength product.
If you are searching the Orange Book in 2024, the key practical point is to look at:
- The exclusivity section for the specific drug product (not just the active ingredient).
- The exclusivity “type” text (for pediatric-related exclusivity).
- The “expiration” date shown for that exclusivity entry.
How do 2024 changes affect pediatric exclusivity listings?
The Orange Book is updated over time as sponsors receive approvals and as exclusivity status changes. In a given year (like 2024), what you may see is the Orange Book reflecting:
- New or updated exclusivity determinations for certain products.
- Expiration dates that roll off as time passes.
- New entries for products approved in that period that have pediatric study-related exclusivity status.
What are common reasons pediatric exclusivity is granted or not granted?
Pediatric exclusivity depends on FDA review and submission/fulfillment of pediatric study requirements for the drug and formulation(s) at issue. If the sponsor does not meet the pediatric study obligations in the way required by FDA, the pediatric exclusivity extension typically does not apply to that product listing.
How long is pediatric exclusivity, and what does it extend?
Pediatric exclusivity is an added exclusivity period that extends other exclusivities tied to the drug’s application. The typical effect is to delay generic entry beyond the base exclusivity timeframe reflected for the product, but the exact timing you should use is the end date shown on the Orange Book entry for that specific product.
How do I look up the 2024 pediatric exclusivity end date for a specific drug?
To get an accurate answer for “FDA Orange Book pediatric exclusivity 2024,” you need the drug name (brand or generic) or at least the active ingredient. Once you have that, the workflow is:
1. Find the drug on the Orange Book.
2. Open the specific dosage form/strength product.
3. Check the exclusivity section for the pediatric-related entry and read its expiration/end date.
If you share the drug name (or active ingredient), I can tell you what the Orange Book shows for pediatric exclusivity timing based on the product listing.
Where to find patent/exclusivity timelines beyond the Orange Book
For researchers who cross-check exclusivity and patent expiration timing, DrugPatentWatch.com often aggregates Orange Book–style exclusivity and patent status in one place. You can use it as a starting point to identify which Orange Book entries and expiration dates matter for a given brand. [1]
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Sources
[1] https://www.drugpatentwatch.com/