Is there a generic for Enzalutamide?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Enzalutamide, referencing the brand XTANDI. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Enzalutamide?

XTANDI (NDA 213674, ASTELLAS) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Enzalutamide?

The Orange Book lists 7 patents against Enzalutamide products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Enzalutamide have FDA marketing exclusivity?

Yes. The Orange Book records 3 marketing-exclusivity periods for Enzalutamide. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Enzalutamide are approved?

Enzalutamide is approved in the following dosage forms: capsule, tablet.

FDA Orange Book · active-ingredient family

Enzalutamide

Enzalutamide: 2 brands, 4 generics; first approved Aug 31, 2012; generic available.

Generic available3 exclusivity periodsHas discontinued products

Generic status & protection

Generic available: 4 ANDA applications approved.

Earliest patent expiry May 15, 2026Latest exclusivity ends Nov 17, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

May 15, 2026

3 mo ago

Brand (NDA) products

Originator applications

XTANDIRLD
ASTELLASNDA 21367420202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG TABLET ORAL Rx AB
80MG TABLET ORAL Rx AB
XTANDIRLDRS
ASTELLASNDA 2034152012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG CAPSULE ORAL Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG	TABLET	ORAL	Rx	AB
80MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG	CAPSULE	ORAL	Rx	—

Generic (ANDA) products (4)

Abbreviated applications

ENZALUTAMIDE
SANDOZANDA 21606820262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG TABLET ORAL Rx AB
80MG TABLET ORAL Rx AB
ENZALUTAMIDE
ZYDUS PHARMSANDA 2096672024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG CAPSULE ORAL Discontinued —
ENZALUTAMIDE
APOTEXANDA 2096452022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG CAPSULE ORAL Discontinued —
ENZALUTAMIDE
ACTAVIS LABS FL INCANDA 2096142021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG CAPSULE ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG	TABLET	ORAL	Rx	AB
80MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG	CAPSULE	ORAL	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

I-926New indication exclusivity (3 years)
Nov 17, 2026
in 3 mo
I-926New indication exclusivity (3 years)
Nov 17, 2026
in 3 mo
I-926New indication exclusivity (3 years)
Nov 17, 2026
in 3 mo

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9126941	May 15, 2026	3 mo ago	U-2345
8183274	Aug 24, 2026	in 12 d	U-1281
7709517	Aug 13, 2027	in 1 yr	SubstanceProduct
12502357	Sep 11, 2033	in 7 yr 2 mo	U-4363
11839689	Sep 11, 2033	in 7 yr 2 mo	Product
12447128	Sep 11, 2033	in 7 yr 2 mo	U-4312
12161628	Feb 23, 2037	in 10 yr 8 mo	U-4101

Approval history

FDA approval span

First approval

Aug 31, 2012

14 yr 2 mo ago

Most recent approval

Apr 20, 2026

4 mo ago

Approvals span 2012–2026 across 6 FDA applications.

Brand (NDA) 233%

Generic (ANDA) 467%

Enzalutamide: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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