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Last Updated: June 2, 2020

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ITRACONAZOLE Drug Profile


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When do Itraconazole patents expire, and what generic alternatives are available?

Itraconazole is a drug marketed by Accord Hlthcare, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Jubilant Generics, Mylan Pharms Inc, Par Pharm Inc, PII, Sandoz, Torrent, Zydus Pharms, and Apotex. and is included in thirteen NDAs.

The generic ingredient in ITRACONAZOLE is itraconazole. There are fifteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the itraconazole profile page.

US ANDA Litigation and Generic Entry Outlook for Itraconazole

A generic version of ITRACONAZOLE was approved as itraconazole by SANDOZ on May 28th, 2004.

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Drug patent expirations by year for ITRACONAZOLE
Drug Prices for ITRACONAZOLE

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Recent Clinical Trials for ITRACONAZOLE

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SponsorPhase
Hutchison Medipharma LimitedPhase 1
Maimonides Medical CenterPhase 2
Odonate Therapeutics, Inc.Phase 1

See all ITRACONAZOLE clinical trials

Recent Litigation for ITRACONAZOLE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Javelin Pharmaceuticals, Inc. v. Mylan Laboratories Limited2016-04-04
SUPERNUS PHARMACEUTICALS, INC. v. PAR PHARMACEUTICAL COMPANIES, INC.2015-01-16
Galderma Laboratories LP v. Tolmar Inc2009-03-03

See all ITRACONAZOLE litigation

Medical Subject Heading (MeSH) Categories for ITRACONAZOLE
Synonyms for ITRACONAZOLE
(+-)-1-sec-Butyl-4-(p-(4-(p-(((2R*,4S*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl)methoxy)phenyl)-1-piperazinyl)phenyl)-delta(sup 2)-1,2,4-triazolin-5-one
(+/-)-4-[4-[4-[4-[[(2R,4S)-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-2,4-dihydro-2-(1-methylpropyl)-3H-1,2,4-triazol-3-one
(+/-)-cis-4-[4-[4-[4-[[2-(2,4-dichlorophenyl)-2-(1h-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]-methoxy]phenyl]-1-piperazinyl]phenyl]-2,4-dihydro-2-(1-methylpropyl)-3h-1,2,4-triazol-3-one
1-(butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one
1-(butan-2-yl)-4-{4-[4-(4-{[2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one
1-(Butan-2-yl)-4-{4-[4-(4-{[2-(2,4-dichlorophenyl)-2-[(1H-1,2,4-triazol-1-yl)methyl]-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one
2-(Butan-2-yl)-4-(4-{4-[4-({(2R,4S)-2-(2,4-dichlorophenyl)-2-[(1H-1,2,4-triazol-1-yl)methyl]-1,3-dioxolan-4-yl}methoxy)phenyl]piperazin-1-yl}phenyl)-2,4-dihydro-3H-1,2,4-triazol-3-one
2-(butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-2,4-dihydro-3H-1,2,4-triazol-3-one
2-(butan-2-yl)-4-{4-[4-(4-{[2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-2,4-dihydro-3H-1,2,4-triazol-3-one
2-butan-2-yl-4-[4-[4-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-1,2,4-triazol-3-one
2-butan-2-yl-4-[4-[4-[4-[[2-(2,4-dichlorophenyl)-2-(1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-1,2,4-triazol-3-one
2-sec-butyl-4-{4-[4-(4-{[2-(2,4-dichlorophenyl)-2-(1h-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-2,4-dihydro-3h-1,2,4-triazol-3-one
2049588-24-9
24236-EP2281816A1
24236-EP2314590A1
2485AH
252964-65-1
3H-1,2,4-Triazol-3-one, 4-(4-(4-(4-((2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl)methoxy)phenyl)-1-piperazinyl)phenyl)-2,4-dihydro-2-(1-methylpropyl)-
3H-1,2,4-Triazol-3-one, 4-[4-[4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-pipera-zinyl]phenyl]-2,4-dihydro-2-(1-methylpropyl)
4-(4-(4-(4-(((2R,4S)-2-((1H-1,2,4-triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-2-(sec-butyl)-2,4-dihydro-3H-1,2,4-triazol-3-one
4-(4-(4-(4-((2-((1H-1,2,4-triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-1-(sec-butyl)-1H-1,2,4-triazol-5(4H)-one
4-(4-(4-(4-((2-((1H-1,2,4-triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-1-sec-butyl-1H-1,2,4-triazol-5(4H)-one
4-(4-{4-[4-({[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methyl}oxy)phenyl]piperazin-1-yl}phenyl)-2-(1-methylpropyl)-2,4-dihydro-3H-1,2,4-triazol-3-one
4-[4-[4-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-sec-butyl-1,2,4-triazol-3-one
4-[4-[4-[4-[[(2R,4S)-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazole-1-ylmethyl)-1,3-dioxolane-4-yl]methoxy]phenyl]piperazino]phenyl]-2-(1-methylpropyl)-4H-1,2,4-triazole-3(2H)-one
4-[4-[4-[4-[[2-(2,4-dichlorophenyl)-2-(1h-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-2,4-dihydro-2-(1-methylpropyl)-3h-1,2,4-triazol-3-one
625I616
84604-65-9
84625-61-6
873066-43-4
A1-01739
AB0012897
AB00383031-14
AB0068822
AB01274818_02
AB01274818_03
AB01274818-01
AB2000585
AC-542
AK133082
AKOS000280875
AKOS015842738
AKOS015961385
AKOS022171690
BCP28497
BDBM50011478
BDBM50127138
BRD-A23067620-001-01-7
BRN 6042047
C35H38Cl2N8O4
CAS-84625-61-6
CCG-100876
CCG-220567
CHEBI:6076
CHEBI:94366
CHEMBL22587
CHEMBL64391
CI0042
cis-Itraconazole
CPD000058959
CS-2127
CTK6C9122
CTK8F8379
D00350
DB01167
DL-427
DSSTox_CID_3180
DSSTox_GSID_23180
DSSTox_RID_76908
DTXSID3023180
EN300-122640
FT-0082511
FT-0601621
HMS2051K14
HMS2090M20
HMS2235M11
HMS3370P13
HMS3393K14
HMS3713B16
HY-17514
I0732
Intraconazole
ITCZ
Itraconazol
Itraconazol [Spanish]
Itraconazole (JP17/USAN)
Itraconazole (Sporanox)
Itraconazole [USAN:BAN:INN:JAN]
Itraconazole & Nyotran
Itraconazole & Nyotran(Liposomal Nystatin)
Itraconazole 2.0 mg/ml in Dimethyl Sulfoxide
Itraconazole EP Impurity E
Itraconazole for system suitability, European Pharmacopoeia (EP) Reference Standard
Itraconazole Impurity E
Itraconazole oral solution
Itraconazole, >=98% (TLC)
Itraconazole, Antibiotic for Culture Media Use Only
Itraconazole, European Pharmacopoeia (EP) Reference Standard
Itraconazole, Pharmaceutical Secondary Standard; Certified Reference Material
Itraconazole, United States Pharmacopeia (USP) Reference Standard
Itraconazole,(S)
Itraconazole(Sporanox)
Itraconazolum [Latin]
Itraconzaole
ITRAZOLE
Itrizole (TN)
ITZ
J-015921
J10270
KS-00000JQ3
KS-1268
LS-1843
M-9651
MCULE-2446846552
MFCD00870168
MLS000028582
MLS000759472
MLS000863291
MLS001148245
MLS001424065
MLS006011958
NC00126
NCGC00018268-02
NCGC00018268-03
NCGC00089812-03
NCGC00274068-01
NCGC00274068-02
NCGC00274068-07
NE57775
NSC-759239
NSC759239
Opera_ID_902
Oriconazole
Pharmakon1600-01505756
PubChem16053
Q-201261
Q27166205
Q411229
R 51211
R-51211
R51211
s2476
SAM001246679
SBI-0206914.P001
SCHEMBL16984893
SCHEMBL23934
SCHEMBL95627
SMR000058959
SMR001827898
Sporanox
Sporanox (TN)
Sporanox(TM)
SR-01000003153
SR-01000003153-5
SR-01000003153-6
ST24025102
STL450986
SW219756-1
Tox21_110854
Tox21_110854_1
trans Itraconazole
VHVPQPYKVGDNFY-ZPGVKDDISA-N
Paragraph IV (Patent) Challenges for ITRACONAZOLE
Tradename Dosage Ingredient NDA Submissiondate
SPORANOX SOLUTION;ORAL itraconazole 020657 2013-05-03
SPORANOX CAPSULE;ORAL itraconazole 020083

US Patents and Regulatory Information for ITRACONAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare ITRACONAZOLE itraconazole CAPSULE;ORAL 205991-001 May 26, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Par Pharm Inc ITRACONAZOLE itraconazole CAPSULE;ORAL 205724-001 Dec 13, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms ITRACONAZOLE itraconazole CAPSULE;ORAL 205080-001 Sep 26, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms ITRACONAZOLE itraconazole SOLUTION;ORAL 205573-001 Oct 30, 2015 AA RX 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

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Serving leading biopharmaceutical companies globally:

Harvard Business School
AstraZeneca
Merck
Dow
Boehringer Ingelheim
Baxter

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