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Last Updated: June 5, 2020

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Fluconazole - Generic Drug Details

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What are the generic drug sources for fluconazole and what is the scope of freedom to operate?

Fluconazole is the generic ingredient in eight branded drugs marketed by Pfizer, Aurobindo Pharma Ltd, Hikma, Ivax Sub Teva Pharms, Sun Pharm Inds Ltd, Taro Pharm Inds, Hikma Farmaceutica, Hospira, Mylan Labs Ltd, Woodward, Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, West-ward Pharms Int, Baxter Hlthcare, Inforlife, Ani Pharms Inc, Aurobindo Pharma, Chartwell, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Generics, Harris Pharm, Mylan, Mylan Pharms Inc, Pliva, Ranbaxy Labs Ltd, Roxane, Taro, Teva, Unique Pharm Labs, and Zydus Pharms, and is included in forty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for fluconazole. Thirty-nine suppliers are listed for this compound. There are five tentative approvals for this compound.

Drug Prices for fluconazole

See drug prices for fluconazole

Drug Sales Revenue Trends for fluconazole

See drug sales revenues for fluconazole

Recent Clinical Trials for fluconazole

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Maimonides Medical CenterPhase 2
Hatem AbuHashimN/A
Shanghai Jiao Tong University School of MedicinePhase 2

See all fluconazole clinical trials

Recent Litigation for fluconazole

Identify potential future generic entrants

District Court Litigation
Case NameDate
Pfizer Inc v. Novopharm Ltd2000-03-10

See all fluconazole litigation

Generic filers with tentative approvals for FLUCONAZOLE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial200MGTABLET;ORAL
  Start Trial  Start Trial150MGTABLET;ORAL
  Start Trial  Start Trial100MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Synonyms for fluconazole
.alpha.-(2,4-Difluorophenyl)-.alpha.-(1H-1,2,4-triazol-1-ylmethyl)-1H-1,2,4-triazole-1-ethanol
1-p-tolylpyridin-2(1H)-one
1,2,4-triazol-1-yl)propan-2-ol
123631-92-5
1H-1,2,4-Triazole-1-ethanol, alpha-(2,4-difluorophenyl)-alpha-(1H-1,2,4-triazol-1-ylmethyl)-
2-(2,4-Difluoro-phenyl)-1,3-bis-[1,2,4]triazol-1-yl-propan-2-ol
2-(2,4-difluorophenyl)-1,3-bis(1,2,4-triazol-1-yl)-2-propanol
2-(2,4-difluorophenyl)-1,3-bis(1,2,4-triazol-1-yl)propan-2-ol
2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)-2-propanol
2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol
2-(2,4-Difluorophenyl)-1,3-di-1H-1,2,4-triazol-1-ylpropan-2-ol
2-(2,4-difluorophenyl)-1,3-di(1,2,4-triazolyl)propan-2-ol
2-(2,4-difluorophenyl)-1,3-di(1H-
2-(2,4-DIFLUOROPHENYL)-1,3-DI(1H-1,2,4-TRIAZOL-1-YL)PROPAN-2-OL
2-[2,4-bis(fluoranyl)phenyl]-1,3-bis(1,2,4-triazol-1-yl)propan-2-ol
2,4-Difluoro-alpha,alpha-1-bis(1H-1,2,4-triazol-1-ylmethyl)benzyl alcohol
2,4-Difluoro-alpha,alpha-bis(1H-1,2,4-triazol-1-ylmethyl)benzyl alcohol
340962-81-4
386F734
86386-73-4
86386-73-4,155347-36-7(H2O),159532-41-9(methanesulfonate)
8VZV102JFY
A841625
AB00052399_09
AB00052399_10
AB00052399-07
AB00052399-08
AB0008515
AB1010904
ABP001077
AC-428
AKOS000280854
Alflucoz
alpha-(2,4-Difluorophenyl)-alpha-(1H-1,2,4-triazol-1-ylmethyl)-1H-1,2,4-triazole-1-ethanol
ANW-42860
Baten
BBL005614
BCP28522
BDBM25817
BIDD:GT0799
Biocanol
Biozolene
BRD-K05977355-001-02-6
BRD-K05977355-001-09-1
BSPBio_003504
C07002
C13H12F2N6O
Canzol
CAS-86386-73-4
CCG-39065
CCRIS 7211
CF0055
CHEBI:46081
CHEMBL106
cid_3365
CPD000471882
Cryptal
CS-1835
CTK4B3573
D00322
DB00196
Diflazon
Diflucan
Diflucan (TN)
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
DIFLUCAN IN SODIUM CHLORIDE 0.9%
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
difluconazole
Dimycon
DivK1c_001030
DL-407
DRG-0005
DSSTox_CID_627
DSSTox_GSID_20627
DSSTox_RID_75701
DTXSID3020627
Elazor
EN300-53634
F0677
F2173-0496
FLC
FLCZ
Flucazol
Fluconazol
Fluconazol [Spanish]
Fluconazole (f)
Fluconazole (JP17/USAN/INN)
Fluconazole [USAN:INN:BAN:JAN]
Fluconazole [USAN:USP:INN:BAN:JAN]
Fluconazole [USAN]
Fluconazole & hGCSF
Fluconazole & Human recombinant granulocyte colony stimulating factor
Fluconazole & MC-510,011
Fluconazole 2.0 mg/ml in Methanol
Fluconazole for peak identification, European Pharmacopoeia (EP) Reference Standard
Fluconazole in combination with MGCD290
Fluconazole in dextrose 5% in plastic container
Fluconazole in sodium chloride 0.9%
Fluconazole in sodium chloride 0.9% in plastic container
Fluconazole solution, 2.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Fluconazole, >=98% (HPLC), powder
Fluconazole, 98%
Fluconazole, European Pharmacopoeia (EP) Reference Standard
Fluconazole, Pharmaceutical Secondary Standard; Certified Reference Material
Fluconazole, United States Pharmacopeia (USP) Reference Standard
Fluconazole,(S)
FLUCONAZOLE; ALPHA-(2,4-DIFLUOROPHENYL)-ALPHA-(1H-1,2,4-TRIAZOLE-1-YLMETHYL)-1H-1,2,4-TRIAZOLE-1-ETHANOL; ELAZOR; TRIFLUCAN; BIOZOLENE
Fluconazolum
Fluconazolum [Latin]
Flucoral
Flucostat
Flukezol
Flunazol
Flunizol
Flusol
Fluzon [Antifungal]
Fluzone
Forcan
FT-0626437
Fuconal
Fungata
HMS1922O10
HMS2090I20
HMS2093M21
HMS2230O22
HMS3259H13
HMS3373I19
HMS3654P15
HMS3715F21
HMS3748G19
HMS503M21
HSDB 7420
HY-B0101
IDI1_001030
J10407
KBio1_001030
KBio2_002134
KBio2_004702
KBio2_007270
KBio3_003009
KBioGR_000360
KBioSS_002134
KM2402
KS-000000NR
KS-1059
Loitin
LS-1858
MCULE-8641424658
MFCD00274549
MG-3290 and Fluconazole
MGCD290 and Fluconazole
MLS001066394
MLS001165780
MLS001195645
MLS001304713
MLS001306492
MLS006011884
Mutum
NC00650
NCGC00095089-01
NCGC00095089-02
NCGC00095089-04
NCGC00095089-05
NCGC00095089-06
NCGC00095089-07
NCGC00095089-08
NCGC00095089-09
NCGC00095089-10
NCGC00095089-11
NCGC00254412-01
NCGC00259789-01
NINDS_001030
NSC-758661
NSC758661
Oxifugol
Pharmakon1600-01503975
Pritenzol
Q-201120
Q411478
RFHAOTPXVQNOHP-UHFFFAOYSA-N
s1331
SAM002589905
SAM002589957
SBB066063
SBI-0051880.P002
SC-12182
SC-26357
SC-35622
SCHEMBL3151
SMR000471882
SPBio_001613
Spectrum_001654
SPECTRUM1503975
Spectrum2_001607
Spectrum3_001912
Spectrum4_000090
Spectrum5_001277
SR-01000765440
SR-01000765440-2
SR-01000765440-4
SR-01000765440-8
ST51039043
STK619301
SW199616-2
Syscan
Tox21_111419
Tox21_111419_1
Tox21_202240
Tox21_300581
TR-038046
Triconal
Triflucan
UK 49858
UK-049858
UK-49,858
UK-49858
UK-49858;UK 49858;UK49858
UNII-8VZV102JFY
Z235354561
Zemyc
ZINC4009
Zoltec
Zonal
Paragraph IV (Patent) Challenges for FLUCONAZOLE
Tradename Dosage Ingredient NDA Submissiondate
DIFLUCAN TABLET;ORAL fluconazole 019949
DIFLUCAN FOR SUSPENSION;ORAL fluconazole 020090

US Patents and Regulatory Information for fluconazole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 019950-002 Jan 29, 1990 DISCN Yes No   Start Trial   Start Trial   Start Trial
Pfizer DIFLUCAN IN SODIUM CHLORIDE 0.9% fluconazole INJECTABLE;INJECTION 019950-001 Jan 29, 1990 DISCN Yes No   Start Trial   Start Trial   Start Trial
Hikma Farmaceutica FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 078764-001 Jan 30, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for fluconazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer DIFLUCAN IN SODIUM CHLORIDE 0.9% fluconazole INJECTABLE;INJECTION 019950-001 Jan 29, 1990   Start Trial   Start Trial
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-003 Jan 29, 1990   Start Trial   Start Trial
Pfizer DIFLUCAN IN SODIUM CHLORIDE 0.9% fluconazole INJECTABLE;INJECTION 019950-001 Jan 29, 1990   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
AstraZeneca
Harvard Business School
Express Scripts
Boehringer Ingelheim
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.