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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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from HYMAN PHELPS MCNAMARA P.C. FDA-2021-P-1082 · 3 docket documents 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	Granted	HYMAN PHELPS MCNAMARA P.C.
Citizen Petition from Public Citizen Health Research Group FDA-2016-P-1874 · 7 docket documents Public Citizen, a consumer advocacy organization, filed this petition on June 29, 2016, requesting that the FDA immediately add a boxed warning to product labeling for all dopamine agonist drugs currently approved in the U.S. (apomorphine, bromocriptine, cabergoline, pramipexole, ropinirole, and rot	Other	2016-07-01	Denied	Public Citizen Health Research Group

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

Clinical Trials

47 trials from ClinicalTrials.gov, 1 active, 33 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas NCT02288962	Phase 3	Active	St. Olavs Hospital	60	2014-11 → 2028-12
Effect of Cabergoline on Weight and Glucose Tolerance NCT01395602	Phase 1/2	Completed	Columbia University	40	2002-04 → 2011-07
Color Doppler Analysıs Of Uterin And Intraovarian Blood Flow Before And After Treatment Wıth Cabergoline In Hyperprolactinemic Patients NCT01957839	Phase 4	Completed	Istanbul Bakirkoy Maternity and Children Diseases Hospital	48	2010-03 → 2011-09
Dopamine Turnover Rate as Surrogate Parameter for Diagnosis of Early Parkinson's Disease NCT00153972	Phase 4	Completed	Technische Universität Dresden	39	2005-02 → 2009-01
Study of Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in In Vito Fertilization Cycles and Derivation of OHSS Biomarkers NCT01535859	Phase 3	Completed	KK Women's and Children's Hospital	46	2012-04 → 2016-06
Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention NCT03473613	Phase 3	Completed	Benha University	230	2014-10-01 → 2017-04-15
Clinical Guidance for Proper Treatment of Unexplained Resistant Hyperprolactinemia.NCT04262024	Phase 1	Completed	Woman's Health University Hospital, Egypt	120	2020-02-01 → 2023-05-01
Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions NCT00652873	Phase 1	Completed	Par Pharmaceutical, Inc.	24	2001-07 → 2001-12
Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients NCT01278342	Phase 4	Completed	Novartis Pharmaceuticals	70	2006-09 → 2009-11
Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects With Parkinson's Disease NCT00129181	N/A	Completed	Institute for Neurodegenerative Disorders	30	2005-01 → 2007-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$1.45

per ea

Lowest NADAC/Unit

$1.45

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
59762100501CABERGOLINE 0.5 MG TABLET	$1.45	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$4.31

Highest Price

$40.93

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59762-1005-01CABERGOLINE 0.5MG TAB	$40.93	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-1005-01CABERGOLINE 0.5MG TAB	$4.31	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Cabergoline (2024)

Total Spending

$6.7M

Total Claims

90,444

Beneficiaries

21,570

Avg Cost/Unit

$4.90

Spending Trend

$7.9M(2019)→$8.0M(2020)→$9.2M(2021)→$9.8M(2022)→$8.6M(2023)→$6.7M(2024)

YoY Change:-30.9%

5yr CAGR:-15.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

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.