Xtandi generics — when can they launch?
Xtandi (enzalutamide) · Astellas Pharma · 14 active US patents · 3 expired
Where Xtandi sits in the generic timeline
All listed Orange Book patents for Xtandi have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Method of Use — 9 patents
- Composition of Matter — 3 patents
- Formulation — 2 patents
FDA U-codes carved out by Xtandi patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-2708 | (no description) |
U-2345 | (no description) |
U-1281 | (no description) |
U-4312 | (no description) |
U-4363 | (no description) |
U-4101 | (no description) |
U-4102 | (no description) |
Sample patent estate
Showing 6 of 14 active US patents. View full estate on the Xtandi drug page →
-
This patent protects diarylhydantoin compounds, including diarylthiohydantoins, for use in treating hormone refractory prostate cancer.USPTO title: Treatment of hyperproliferative disorders with diarylhydantoin compounds
-
This patent protects diarylhydantoin compounds, including diarylthiohydantoins, for use in treating hormone refractory prostate cancer.USPTO title: Treatment of hyperproliferative disorders with diarylhydantoin compounds
-
This patent protects diarylhydantoin compounds, including diarylthiohydantoins, for use in treating hormone refractory prostate cancer.USPTO title: Treatment of hyperproliferative disorders with diarylhydantoin compounds
-
The patent protects diarylhydantoin compounds, including diarylthiohydantoins, and methods for synthesizing and using them to treat hormone refractory prostate cancer.USPTO title: Diarylhydantoin compounds
-
The patent protects diarylhydantoin compounds, including diarylthiohydantoins, and methods for synthesizing and using them to treat hormone refractory prostate cancer.USPTO title: Diarylhydantoin compounds
-
The patent protects diarylhydantoin compounds, including diarylthiohydantoins, and methods for synthesizing and using them to treat hormone refractory prostate cancer.USPTO title: Diarylhydantoin compounds
Sources
- FDA Orange Book — patents listed against Xtandi (NDA filed 2012)
- Xtandi drug profile — full patent estate, indications, clinical trials, pricing
- Astellas Pharma patent portfolio
- Patent cliff 2026 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
Get generic entry alerts
Free Pharma CI alerts on Xtandi — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.
Subscribe free →