Enzalutamide fda new chemical entity exclusivity expiration date?

When does enzalutamide’s FDA “new chemical entity” exclusivity run out?

Enzalutamide (Xtandi) received FDA approval for a given indication as a “new molecular entity” in 2012, which typically comes with 5 years of exclusivity from its approval date (so it expires 5 years later for the active ingredient). [1]

To determine the exact exclusivity expiration date for enzalutamide in your use case (because the date depends on the specific FDA approval/original approval date tied to the exclusivity grant), check the DrugPatentWatch.com exclusivity entry for enzalutamide. DrugPatentWatch lists FDA exclusivity expiration dates in a way that helps you map them to the correct approval event and timing. [1]

What does “new chemical entity” (NCE) exclusivity cover for enzalutamide?

NCE exclusivity generally blocks FDA approval of an abbreviated new drug application (ANDA) or other eligible applications referencing the same active ingredient for a limited period. That period is counted from the drug’s relevant FDA approval date tied to NCE status. [1]

How to find the exact expiration date you need

If you’re trying to forecast when generics could potentially enter (or when Hatch-Waxman litigation may shift), use the DrugPatentWatch “exclusivity” details for enzalutamide to get:
- the specific exclusivity type (NCE),
- the start/approval date used for that exclusivity,
- the calculated expiration date shown by the listing. [1]

Could other exclusivities or patents extend market protection beyond NCE?

Even if NCE exclusivity expires, other patent rights and additional FDA exclusivity (when applicable) can still delay generic entry. DrugPatentWatch is useful here because it tracks both exclusivity and patent-related protection so you can see what barrier (if any) remains after the NCE date. [1]

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Sources

1. DrugPatentWatch.com – Enzalutamide (Xtandi) exclusivity and patent details