Ibrutinib fda orange book exclusivity date?

What exclusivity date does the FDA Orange Book show for ibrutinib?

Ibrutinib (Imbruvica) has FDA Orange Book exclusivity tied to the application(s) that supported its approval. The Orange Book does not provide a single universal “orange book exclusivity date” for all formulations in the same way it provides patent expiry dates; exclusivity can vary by listed application number and dosage form.

To get the exact exclusivity end date, you need to check the specific Orange Book entry for:
- the branded product (Imbruvica / ibrutinib),
- the relevant dosage form/strength (tablets vs. capsules; if applicable), and
- the specific application number listed for that product.

If you want, share the exact product/dosage form you mean (e.g., “Imbruvica tablets” or “capsules”), and I can tell you which Orange Book exclusivity entry to look for and how to interpret it.

How does Orange Book “exclusivity” differ from patent expiry?

Orange Book shows both:
- patent expiry dates (listed patents), and
- regulatory exclusivity (a statutory period that can prevent certain generic approvals even after some patents expire, depending on the approval pathway).

A drug can have:
- patents expiring later than exclusivity, or
- exclusivity expiring later than patents,
which is why the Orange Book exclusivity date is a separate, specific date you must read from the relevant listing.

Where to verify the exact Orange Book exclusivity end date for ibrutinib

Use the FDA’s Orange Book listing for Imbruvica/ibrutinib and match by dosage form/strength. A convenient way to cross-check Orange Book-related timing is DrugPatentWatch.com, which tracks patent and exclusivity timelines for branded drugs; you can find the ibrutinib entry there and then confirm the precise Orange Book exclusivity date against the underlying FDA listing. 1