Is there a generic for Cabergoline?

Yes. The FDA Orange Book lists 9 approved generic (ANDA) applications for Cabergoline, referencing the brand DOSTINEX. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Cabergoline?

DOSTINEX (NDA 020664, PFIZER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Cabergoline are approved?

Cabergoline is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Cabergoline

Cabergoline: 1 brand, 9 generics; first approved Dec 23, 1996; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 9 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

DOSTINEXRLD

PFIZERNDA 0206641996

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (9)

CABERGOLINE

SOMERSET THERAPS LLCANDA 2181092024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB

CABERGOLINE

AMNEALANDA 2186182024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB

CABERGOLINERS

INGENUS PHARMS LLCANDA 2047352018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB

CABERGOLINE

PHARMOBEDIENTANDA 2029472013

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—

CABERGOLINE

APOTEX CORPANDA 2015032013

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—

CABERGOLINE

ACTAVIS LABS FL INCANDA 0780352008

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—

CABERGOLINE

IMPAX LABS INCANDA 0778432007

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—

CABERGOLINE

IVAX SUB TEVA PHARMSANDA 0777502007

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB

CABERGOLINE

STRIDES PHARMA INTLANDA 0763102005

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	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

Dec 23, 1996

30 yr ago

Most recent approval

Sep 09, 2024

1 yr 10 mo ago

Approvals span 1996–2024 across 10 FDA applications.

Brand (NDA) 110%

Generic (ANDA) 990%

Cabergoline — 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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