Viewing data from:

DOSTINEX

NDA

CABERGOLINE | N020664 | PFIZER INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from HYMAN PHELPS MCNAMARA P.C. FDA-2021-P-1082 Hyman, Phelps & McNamara P.C., on behalf of a client, filed a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Cabergoline Tablets, 0.25 mg, suitable for submission as an Abbreviated New Drug Application, with Dostinex T	Suitability	2021-10-07	Open	HYMAN PHELPS MCNAMARA P.C.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs9 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

FINETECH PHARMACEUTICAL LTDCABERGOLINE DRUG SUBSTANCE

DMF 154232001

TAPI NL BVCABERGOLINE

DMF 181132005

CF PHARMA LTDCABERGOLINE

DMF 321452017

ANTIBIOTICOS SPAInactiveCABERGOLINE ACTIVE DRUG SUBSTANCE

DMF 75331988

ANTIBIOTICOS SPAInactiveCABERGOLINE FINISHED DOSAGE

DMF 75341988

IVAX CRInactiveCABERGOLINE

DMF 159332002

GEDEON RICHTER PLCInactiveCABERGOLINE

DMF 181992005

RESOLUTION CHEMICALS LTDInactiveCABERGOLINE DRUG SUBSTANCE

DMF 189722005

APOTEX PHARMACHEM INDIA PVT LTDInactiveCABERGOLINE USP

DMF 226202009

MYLAN LABORATORIES LTDInactiveCABERGOLINE USP

DMF 239182010

APOTEX PHARMACHEM INDIA PVT LTDInactiveCABERGOLINE USP

DMF 262352012

PFIZER INCInactiveCABERGOLINE USP

DMF 287422014

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Apr 25, 2025	SUPPL -16	View Letter (PDF)
Dec 17, 2019	SUPPL -17	View Letter (PDF)
Sep 10, 2014	SUPPL -13	View Letter (PDF)
Oct 20, 2011	SUPPL -12	View Letter (PDF)
Jul 21, 2011	SUPPL -11	View Letter (PDF)
Jan 9, 2008	SUPPL -10	View Letter (PDF)
Feb 23, 2007	SUPPL -7	View Letter (PDF)
Dec 28, 2006	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 23, 1996

No patent or exclusivity listings for this strength.