Xtandi+patent?

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Xtandi+patent?

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Xtandi (enzalutamide) – quick snapshot

Item	Detail
Brand name	Xtandi
Active ingredient	Enzalutamide (a non‑steroidal anti‑androgen)
Approval	FDA approval for metastatic castration‑resistant prostate cancer (mCRPC) in 2012; extended to non‑metastatic castration‑resistant prostate cancer (nmCRPC) in 2018.
Original developer	Janssen Pharmaceuticals (a Johnson & Johnson S & S subsidiary). The core chemistry was licensed from the University of Texas at Austin.
Typical dosing	160 mg orally once daily (with a 2‑week titration period in some cases).

Patent landscape

Patent number	Title (brief)	Filing / Grant	Expiry	What it covers
US 7,069,777	“2‑(5‑chloropyrrol‑3‑yl)-4‑[(pyridin‑4‑yl)amino]‑3‑phenyl‑piperidine‑1‑carboxylate”	Filed 1997 / Granted 2006	2017	Structural claim of enzalutamide.
US 7,860,476	“Synthesis of enzalutamide”	Filed 2002 / Granted 2010	2022	Synthetic route to the drug.
US 7,882,073	“Synthesis of enzalutamide”	Filed 2002 / Granted 2010	2022	Alternative synthetic route.
US 8,347,444	“Pharmaceutical composition of enzalutamide”	Filed 2006 / Granted 2013	2026	Specific formulation and excipient blend.
US 7,879,547	“Methods of treating prostate cancer”	Filed 2004 / Granted 2010	2021	Clinical use claim (mCRPC and nmCRPC).
US 8,076,456	“Enzalutamide and its use in non‑metastatic prostate cancer”	Filed 2008 / Granted 2012	2023	Indication claim for nmCRPC.
WO 2010/040133	“Use of enzalutamide for androgen‑dependent disease”	Filed 2010	2022	International claim for broader therapeutic use.

Key take‑away:

The core composition patent (US 7,069,777) expired in 2017.
Most of the later patents that cover synthetic routes, formulation, and specific indications expire between 2021 and 2026.
As a result, generic enzalutamide has become available in many markets (e.g., Canada, EU, Australia) since 2019‑2020, once the most restrictive patents expired.
However, some formulation and indication patents still provide Janssen with certain exclusivities for a few more years in specific regions (e.g., the US still has a formulation patent expiring 2026).

What does this mean for patients and prescribers?

What you might hear	Why it matters
“Generic enzalutamide is now available.”	After the main patents expired, generic manufacturers can market the drug, usually at a lower cost.
“Janssen still holds a formulation patent until 2026.”	Even if generics exist, the company may retain exclusivity over a specific tablet formulation in the US, delaying the entry of identical generics.
“No new patents covering the drug’s use in prostate cancer until 2023.”	The therapeutic claims are still protected until that date in the US, but generic manufacturers can still market the drug for approved uses once the primary patents lapse.

Where to find up‑to‑date patent status

USPTO’s Patent Full‑Text and Image Database (PatFT) – search by “enzalutamide” or “Xtandi”.
European Patent Office (EPO) Espacenet – browse the patent family for international filings.
FDA’s Orange Book – lists “Patent and exclusivity information” for approved drugs.
PatentWatch / Innography – commercial services that track expiry and litigation status.

Bottom line:
Xtandi’s core chemistry patent expired in 2017, and most subsequent patents on synthesis, formulation, and indications have lapsed or are close to lacing. Generics are widely available, but Janssen retains a few formulation and indication exclusivities that may still influence market dynamics for a few more years. If you’re considering treatment options, talk with a healthcare provider about whether the brand‑name drug is still recommended or if a generic alternative is appropriate for your specific case.

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Xtandi+patent?

Patent landscape

What does this mean for patients and prescribers?

Where to find up‑to‑date patent status