Viewing data from:

DIFLUCAN

NDA

FLUCONAZOLE | N020090 | PFIZER CHEMICALS DIV PFIZER INC

2 strengths0 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

152 trials from ClinicalTrials.gov — 2 recruiting, 130 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
PTX3-targeted Antifungal Prophylaxis NCT03828773	N/A	Recruiting	Bochud Pierre-Yves	410	2019-02-11 → 2027-11-30
Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia NCT03945448	Phase 2/3	Recruiting	Makerere University	356	2019-06-20 → 2027-08
A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) and Fungal Infections in HIV-Infected Patients NCT00002122	Phase 3	Completed	Pfizer	720	—
A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients With AIDS NCT00002294	N/A	Completed	Pfizer	—	—
Prediction of Drug Interactions With CYP2C9 Substrates NCT00226538	N/A	Completed	Hadassah Medical Organization	16	1999-08
An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis NCT00002077	N/A	Completed	Pfizer	—	—
A Study to Evaluate the Effect of Fluconazole and Itraconazole on Erdafitinib Pharmacokinetics in Healthy Adult Participants NCT03135106	Phase 1	Completed	Janssen Research & Development, LLC	54	2017-04-14 → 2017-09-01
Effect of Fluconazole on the Levels of ASCA After Surgical Resection for Crohn's Disease.NCT02997059	Phase 2	Completed	University Hospital, Lille	35	2008-07 → 2015-06
A Drug Interaction Study of LY3154207 in Healthy Participants NCT03942029	Phase 1	Completed	Eli Lilly and Company	36	2019-06-21 → 2019-12-28
Operational Research for Cryptococcal Antigen Screening NCT01535469	Phase 4	Completed	University of Minnesota	3,049	2012-07-01 → 2015-06

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$0.5122

per ml

Lowest NADAC/Unit

$0.2639

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
59762503001FLUCONAZOLE 40 MG/ML SUSP	$0.5122	ML	Generic	—	2026-06-17
59762502901FLUCONAZOLE 10 MG/ML SUSP	$0.2639	ML	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 | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$5.87

Highest Price

$22.46

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59762-5030-01FLUCONAZOLE 40MG/ML SUSP,ORAL	$22.46	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-5030-01FLUCONAZOLE 40MG/ML SUSP,ORAL	$13.04	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
00049-3450-19DIFLUCAN 40MG/ML SUSP, PWD	$21.11	FSS	Pfizer Inc.	06/30/2029
00049-3450-19DIFLUCAN 40MG/ML SUSP, PWD	$16.09	Big4	Pfizer Inc.	06/30/2029
59762-5029-01FLUCONAZOLE 10MG/ML SUSP,ORAL	$9.92	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-5029-01FLUCONAZOLE 10MG/ML SUSP,ORAL	$5.87	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027

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

API Supply Chain15 active DMFs13 inactive

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

QUIMICA SINTETICA SAFLUCONAZOLE

DMF 89751991

INKE SAFLUCONAZOLE

DMF 147141999

MATRIX PHARMACORP PRIVATE LTDFLUCONAZOLE USP

DMF 150452000

CIPLA LTDFLUCONAZOLE USP

DMF 151612000

TARO PHARMACEUTICAL INDUSTRIES LTDFLUCONAZOLE USP

DMF 158222002

ZYDUS LIFESCIENCES LTDFLUCONAZOLE USP

DMF 162972002

DR REDDYS LABORATORIES LTDFLUCONAZOLE (FORM-2)

DMF 163162003

APITORIA PHARMA PRIVATE LTDFLUCONAZOLE USP

DMF 181762005

ALIVUS LIFE SCIENCES LTDFLUCONAZOLE USP

DMF 207342007

VIRUPAKSHA ORGANICS LTDFLUCONAZOLE USP

DMF 244372010

HENAN PURUI PHARMACEUTICAL CO LTDFLUCONAZOLE

DMF 374202022

SYNERGENE ACTIVE INGREDIENTS PRIVATE LTDFLUCONAZOLE USP

DMF 377032023

APITORIA PHARMA PRIVATE LTDFLUCONAZOLE USP (CIP PROCESS)

DMF 398762024

ATUL BIOSCIENCE LTDFLUCONAZOLE

DMF 404262024

ENDOC LIFECARE PVT LTDFLUCONAZOLE USP

DMF 424882025

CIPLA LTDInactiveFLUCONAZOLE USP

DMF 115241995

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDInactiveFLUCONAZOLE

DMF 144191999

WOCKHARDT LTDInactiveFLUCONAZOLE

DMF 148632000

GEDEON RICHTER LTDInactiveFLUCONAZOLE

DMF 158832002

CADILA PHARMACEUTICALS LTDInactiveFLUCONAZOLE

DMF 163912002

SIGNA SA DE CVInactiveFLUCONAZOLE

DMF 164202003

FDC LTDInactiveFLUCONAZOLE

DMF 166322003

GLENMARK GENERICS LTDInactiveFLUCONAZOLE

DMF 170972004

APOTECNIA SAInactiveFLUCONAZOLE

DMF 172942004

IPCA LABORATORIES LTDInactiveFLUCONAZOLE USP

DMF 209292007

GRANULES INDIA LTDInactiveFLUCONAZOLE USP

DMF 227102009

POLYDRUG LABORATORIES PVT LTDInactiveFLUCONAZOLE

DMF 234052009

IPCA LABORATORIES LTDInactiveFLUCONAZOLE USP (G3 PROCESS)

DMF 247682011

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

Approval Letters

24 letters from Drugs@FDA

Date	Submission	Document
Feb 13, 2024	SUPPL -53	View Letter (PDF)
Jul 13, 2023	SUPPL -55	View Letter (PDF)
Jan 18, 2023	SUPPL -54	View Letter (PDF)
Mar 10, 2022	SUPPL -52	View Letter (PDF)
Oct 27, 2021	SUPPL -51	View Letter (PDF)
Sep 9, 2020	SUPPL -50	View Letter (PDF)
Feb 20, 2019	SUPPL -47	View Letter (PDF)
Mar 15, 2018	SUPPL -46	View Letter (PDF)
Jan 26, 2018	SUPPL -49	View Letter (PDF)
Jan 26, 2018	SUPPL -49	View Letter (PDF)
Oct 31, 2017	SUPPL -48	View Letter (PDF)
Oct 31, 2014	SUPPL -44	View Letter (PDF)
Mar 25, 2014	SUPPL -42	View Letter (PDF)
Sep 17, 2013	SUPPL -40	View Letter (PDF)
Nov 21, 2011	SUPPL -38	View Letter (PDF)
Jun 8, 2011	SUPPL -34	View Letter (PDF)
Apr 29, 2011	SUPPL -36	View Letter (PDF)
Aug 10, 2010	SUPPL -31	View Letter (PDF)
Apr 4, 2008	SUPPL -22	View Letter (PDF)
Oct 8, 2004	SUPPL -12	View Letter (PDF)
Oct 8, 2004	SUPPL -17	View Letter (PDF)
Oct 8, 2004	SUPPL -14	View Letter (PDF)
Mar 28, 2004	SUPPL -19	View Letter (PDF)
Aug 7, 2002	SUPPL -15	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG/5ML

RLDAB

0 patents0 exclusivities▴

FOR SUSPENSION;ORAL | Approved: Dec 23, 1993

No patent or exclusivity listings for this strength.

#002 — 200MG/5ML

RLDAB

0 patents0 exclusivities▾

FOR SUSPENSION;ORAL | Approved: Dec 23, 1993