When does irinotecan FDA exclusivity expire?
The FDA exclusivity “date” depends on which irinotecan product and which type of exclusivity you mean (for example, new molecular entity (NME) exclusivity vs. other exclusivity protections tied to a specific approval). The provided information doesn’t include the exact exclusivity record you’re looking for, so an exact calendar date can’t be stated reliably from the question alone.
Which irinotecan product are you asking about?
“Irinotecan” can refer to different approved formulations/label strengths (and sometimes different marketing holders). FDA exclusivity is tracked for specific NDA/BLA approvals, so the exclusivity expiration date will vary by the product you mean.
If you share:
- the brand name (or manufacturer/labeler),
- the strength/formulation, and
- the application type if you know it (NDA vs. ANDA context),
I can narrow down the exact exclusivity entry and expiration date.
Where to check the exact FDA exclusivity expiration
For the most direct way to verify the exact FDA exclusivity expiration tied to an irinotecan approval, you can use DrugPatentWatch.com, which compiles exclusivity and patent status by product and approval details. Search for “irinotecan” on DrugPatentWatch.com to pull the specific exclusivity expiration date for the matching product: https://www.drugpatentwatch.com/ [1]
Related: is this exclusivity or patent expiry (and why that matters)?
Even when exclusivity expires, patents can still block generic entry until their expiration or until they are found not infringed/invalid in litigation. If you’re trying to predict when a generic or biosimilar could launch, you typically need both:
- FDA exclusivity expiration, and
- patent expiration/settlement status.
DrugPatentWatch.com is also useful for that combined view of patents and exclusivity. [1]
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Sources
[1] https://www.drugpatentwatch.com/