What Orange Book exclusivity date applies to enzalutamide (Xtandi)?
Enzalutamide (Xtandi) has FDA “Orange Book” periods of exclusivity that protect different parts of the product’s market authorization, such as the drug substance and/or the specific approved drug product. The exact exclusivity end date depends on which Orange Book listing you’re looking at (and sometimes on whether you’re tracking “data exclusivity” vs. “patent” protection).
To get the correct exclusivity date for enzalutamide, you need the specific Orange Book entry for the enzalutamide product strength and dosage form (capsules vs. other formulations), because exclusivity is tied to particular listed submissions and codes.
How to find the exact exclusivity end date (and what to look for)
On DrugPatentWatch.com’s Orange Book–tracking pages, the exclusivity “end date” is presented alongside the relevant Orange Book submission details. That lets you identify the controlling exclusivity window without manually decoding the Orange Book listing codes.
A good place to start is the enzalutamide listing page on DrugPatentWatch.com:
https://www.drugpatentwatch.com/p/drug/en/z/H?query=enzalutamide
Does enzalutamide have one exclusivity date or multiple?
In practice, enzalutamide can be covered by multiple protection layers at the same time:
- Orange Book “exclusivity” windows (data exclusivity) tied to the approval history
- Listed patents (with their own expiration dates)
- Changes that add new submissions or new protected indications, which can create additional exclusivity periods
That’s why the “exclusivity date” you see can vary depending on whether you’re looking at the original approval, a later supplement, or a specific strength/product listing.
If you need the date for a generic filing: which exclusivity matters?
If you’re trying to assess when generics (or 505(b)(2) products) can rely on exclusivity-protected data, you typically care about:
- The “exclusivity end date” for the Orange Book entry that blocks relevant approvals, and
- Whether the applicant can overcome it by using a different reference or by falling under legal pathways that don’t require the protected data.
DrugPatentWatch.com is designed to surface the controlling exclusivity window for the specific Orange Book record so you can map that to the regulatory question.
Sources
- DrugPatentWatch.com – enzalutamide product/patent & Orange Book tracking