Viewing data from:

MONISTAT

NDA

MICONAZOLE | N018040 | JANSSEN PHARMACEUTICA PRODUCTS LP

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent NCT07524439	N/A	Recruiting	University of Alberta	60	2026-05-01 → 2028-11-30

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

API Supply Chain2 active DMFs9 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

OLON SPAMICONAZOLE

DMF 178712004

YUNG ZIP CHEMICAL IND CO LTDMICONAZOLE BASE

DMF 309882016

ERREGIERRE SPAInactiveMICONAZOLE BASE

DMF 70401987

CHEMI SPAInactiveMICONAZOLE BASE

DMF 96481992

KV PHARMACEUTICAL COInactiveMICONAZOLE VAGINAL CREAM

DMF 105791993

JANSSEN PHARMACEUTICA NVInactiveMICONAZOLE DRUG SUBSTANCE

DMF 109121994

YUNG ZIP CHEMICAL IND CO LTDInactiveMICONAZOLE

DMF 151102000

FARCHEMIA SRLInactiveMICONAZOLE BASE

DMF 182482005

CATALENT PHARMA SOLUTIONSInactiveMICONAZOLE GELATIN ENCAPSULATED VAGINAL SUPPOSITORY 200 MG

DMF 199432006

CATALENT PHARMA SOLUTIONS LLCInactiveMICONAZOLE 1200 MG SOFTGELS

DMF 206272007

FDC LTDInactiveMICONAZOLE USP

DMF 248792011

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

Products (1)

#001 — 10MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.