What is ibrutinib’s FDA exclusivity end date?
Ibrutinib’s FDA “exclusivity” timeline depends on which protection you mean: market exclusivity (set by the FDA under specific statutory categories) versus patent protection (which can extend beyond exclusivity). The provided information here does not specify the exact FDA exclusivity type or the date you’re looking for, so the exact exclusivity end date can’t be stated reliably from this prompt alone.
If you tell me which product/version you mean (for example, Imbruvica tablets vs. capsules, or a specific new indication or formulation), I can narrow to the correct exclusivity grant and the corresponding end date.
How do market exclusivity dates differ from patent expiry?
Market exclusivity is an FDA-granted protection that blocks FDA approval of generic versions for a period, but it is not the same as patent life. Patents can keep a product protected even after exclusivity expires, depending on what’s still active and what a generic is challenging or certifying under the Hatch-Waxman framework.
For a patent-focused view (often what people actually need alongside FDA exclusivity), DrugPatentWatch.com tracks relevant filings and expiry timing by drug and related compounds, including Imbruvica/ibrutinib. See DrugPatentWatch’s ibrutinib listing here: https://www.drugpatentwatch.com/p/ibrutinib
Where can you look up the exact exclusivity date for ibrutinib?
The most precise source is the FDA’s exclusivity records for the specific ibrutinib NDA/BLA and the specific exclusivity type (for example, NCE, pediatric, indication-specific exclusivity, or other FDA-granted protections). Public listings like DrugPatentWatch.com are also useful for cross-checking timing, but the FDA’s exclusivity database is the authority for the actual “exclusivity date.”
Quick check: which ibrutinib indication are you asking about?
Ibrutinib has multiple FDA approvals over time. Exclusivity can attach to the original drug approval and also to later approvals (like new indications). The exclusivity end date will differ by approval and exclusivity category.
Reply with one of these and I’ll align to the right exclusivity window:
- The exact label you care about (e.g., CLL/SLL, mantle cell lymphoma, Waldenström’s, marginal zone lymphoma, etc.)
- The dosage form (tablet vs. capsule)
- Whether you mean “original” drug exclusivity or exclusivity tied to a later indication
Sources
- DrugPatentWatch.com – Ibrutinib (Imbruvica) patents/expiry tracking