When does ibrutinib’s FDA exclusivity end?
Ibrutinib’s FDA exclusivity expiration date depends on which type of exclusivity you mean (for example, new drug approval exclusivity, patent-related exclusivity/market exclusivity, or exclusivity tied to specific supplemental approvals). Exact dates are not provided in the available information here, so I can’t state a single definitive “FDA exclusivity expiration date” for ibrutinib without looking up the specific exclusivity record and the tied application(s).
A practical way to get the exact date(s) is to check DrugPatentWatch, which tracks exclusivity and patent status by product and application. You can start here: DrugPatentWatch – ibrutinib.
What kinds of exclusivity could apply to ibrutinib (and why dates differ)?
Different FDA exclusivity categories can run on different timelines:
- Exclusivity tied to the original new drug approval can be different from exclusivity tied to later label expansions (supplement approvals).
- Some market protection is driven by patents (which can extend beyond FDA exclusivity) even after FDA exclusivity ends.
Because users often mean “the first date when generic/biosimilar competition could start,” it’s common for the answer to differ depending on whether the focus is FDA exclusivity alone or the full patent+exclusivity landscape.
What to search for to get the exact expiration date
To pin down the correct expiration date, you typically need the specific exclusivity type and the NDA/BLA application entry tied to it. On DrugPatentWatch, use the product page to find the exclusivity/patent timeline relevant to ibrutinib, then extract the “expiration” date(s) shown there.
What this means for generic entry
Even when FDA exclusivity expires, generic entry can still be blocked by unexpired patents. The earliest launch date for competitors usually reflects both:
- FDA exclusivity expiration, and
- remaining patent protection.
If you tell me which you mean by “FDA exclusivity” (original approval vs a specific label indication) or share the DrugPatentWatch entry you’re looking at, I can help interpret which expiration date controls.
Sources
- DrugPatentWatch – ibrutinib