Is there a generic for Apalutamide?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Apalutamide, referencing the brand ERLEADA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Apalutamide?

ERLEADA (NDA 210951, JANSSEN BIOTECH) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Apalutamide?

The Orange Book lists 14 patents against Apalutamide products, with the earliest listed expiry in 2027. 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.

What dosage forms of Apalutamide are approved?

Apalutamide is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Apalutamide

Apalutamide: 1 brand, 1 generic; first approved Feb 14, 2018; generic available.

Generic available

Generic status & protection

Generic available: 1 ANDA application approved.

Earliest patent expiry Mar 27, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Mar 27, 2027

in 7 mo

Brand (NDA) products

Originator applications

ERLEADARLD
JANSSEN BIOTECHNDA 21095120182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
60MG TABLET ORAL Rx AB
240MG TABLET ORAL Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
60MG	TABLET	ORAL	Rx	AB
240MG	TABLET	ORAL	Rx	—

Generic (ANDA) products (1)

Abbreviated applications

APALUTAMIDE
ZYDUS LIFESCIENCESANDA 2171132025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
60MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
60MG	TABLET	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

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
8802689	Mar 27, 2027	in 7 mo	U-2237
9987261	Mar 27, 2027	in 7 mo	Product
9388159	Mar 27, 2027	in 7 mo	SubstanceProduct
8445507	Feb 14, 2032	in 5 yr 7 mo	SubstanceProductU-2624
9481663	Jun 04, 2033	in 6 yr 11 mo	SubstanceProductU-2624
9884054	Sep 23, 2033	in 7 yr 2 mo	U-2237
RE50642	Sep 23, 2033	in 7 yr 2 mo	U-4450
RE49353	Sep 23, 2033	in 7 yr 2 mo	U-2381
10849888	Sep 23, 2033	in 7 yr 2 mo	U-3013
12303493	Dec 03, 2035	in 9 yr 5 mo	Product
10702508	Apr 30, 2038	in 11 yr 10 mo	U-3012
12303497	Jan 30, 2040	in 13 yr 8 mo	U-4448
11963952	Jan 30, 2040	in 13 yr 8 mo	U-3901
11723898	Jan 14, 2041	in 14 yr 7 mo	U-4449

Approval history

FDA approval span

First approval

Feb 14, 2018

8 yr 8 mo ago

Most recent approval

Mar 17, 2025

1 yr 5 mo ago

Approvals span 2018–2025 across 2 FDA applications.

Brand (NDA) 150%

Generic (ANDA) 150%

Apalutamide: 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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