Is there a generic for Naltrexone hydrochloride?

Yes. The FDA Orange Book lists 7 approved generic (ANDA) applications for Naltrexone hydrochloride, referencing the brand REVIA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Naltrexone hydrochloride?

REVIA (NDA 018932, TEVA WOMENS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Naltrexone hydrochloride are approved?

Naltrexone hydrochloride is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Naltrexone hydrochloride

Naltrexone hydrochloride: 1 brand, 7 generics; first approved Nov 20, 1984; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 7 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

REVIARLD

TEVA WOMENSNDA 0189321984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (7)

NALTREXONE HYDROCHLORIDE

CHARTWELLANDA 2079052017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Rx	AB

NALTREXONE HYDROCHLORIDE

SUN PHARMANDA 0903562012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Rx	AB

NALTREXONE HYDROCHLORIDE

ACCORD HLTHCAREANDA 0912052011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Rx	AB

NALTREXONE HYDROCHLORIDE

SPECGX LLCANDA 07626420023 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	—
50MG	TABLET	ORAL	Rx	AB
100MG	TABLET	ORAL	Rx	—

NALTREXONE HYDROCHLORIDE

NOVITIUM PHARMAANDA 0754342000

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Discontinued	—

NALTREXONE HYDROCHLORIDE

ELITE LABSANDA 0752741999

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Rx	AB

NALTREXONE HYDROCHLORIDE

BARRANDA 0749181998

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	TABLET	ORAL	Rx	AB

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Nov 20, 1984

42 yr 3 mo ago

Most recent approval

Jul 21, 2017

9 yr 1 mo ago

Approvals span 1984–2017 across 8 FDA applications.

Brand (NDA) 113%

Generic (ANDA) 788%

Naltrexone hydrochloride — 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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