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Last Updated: November 21, 2019

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Itraconazole - Generic Drug Details

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

Itraconazole is the generic ingredient in four branded drugs marketed by Accord Hlthcare, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Anda Repository, Jubilant Generics, Mylan Pharms Inc, Par Pharm Inc, Sandoz, Torrent, Zydus Pharms, Janssen Pharms, Mayne Pharma Intl, Apotex Inc, and Sebela Ireland Ltd, and is included in eighteen NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Itraconazole has thirty-three patent family members in twelve countries.

There are fifteen drug master file entries for itraconazole. Twenty suppliers are listed for this compound.

Summary for itraconazole

International Patents:	33
US Patents:	6
Tradenames:	4
Applicants:	15
NDAs:	18
Drug Master File Entries:	15
Suppliers / Packagers:	20
Bulk Api Vendors:	127
Clinical Trials:	242
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for itraconazole
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for itraconazole
DailyMed Link:	itraconazole at DailyMed

See drug prices for itraconazole

Recent Clinical Trials for itraconazole

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

Sponsor	Phase
Assembly Biosciences	Phase 1
Hospital de Clinicas de Porto Alegre	Phase 2
Alessandro Pasqualotto	Phase 2

See all itraconazole clinical trials

Recent Litigation for itraconazole

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Javelin Pharmaceuticals, Inc. v. Mylan Laboratories Limited	2016-04-04
SUPERNUS PHARMACEUTICALS, INC. v. PAR PHARMACEUTICAL COMPANIES, INC.	2015-01-16
Galderma Laboratories LP v. Tolmar Inc	2009-03-03

See all itraconazole litigation

Pharmacology for itraconazole

Drug Class	Azole Antifungal
Mechanism of Action	Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors Breast Cancer Resistance Protein Inhibitors

Medical Subject Heading (MeSH) Categories for itraconazole

14-alpha Demethylase Inhibitors
Antifungal Agents
Cytochrome P-450 CYP3A Inhibitors

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)-cis-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-2-sec-butyl-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
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-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]piperazin-1-yl]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
AC1L1GQ5
AC1L1IRU
AC1Q6EZ3
AK133082
AKOS000280875
AKOS015842738
AKOS015961385
AKOS022171690
AN-15748
BC206651
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
DRG-0044
DSSTox_CID_3180
DSSTox_GSID_23180
DSSTox_RID_76908
DTXSID3023180
EINECS 283-347-2
EN300-122640
FT-0082511
FT-0601621
HMS2051K14
HMS2090M20
HMS2235M11
HMS3370P13
HMS3393K14
HMS3713B16
HY-17514
I01-1043
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)
Itraconazolum
Itraconazolum [Latin]
Itraconzaole
ITRAZOLE
Itrizole
Itrizole (TN)
ITZ
J-015921
J10270
KB-53026
KS-00000JQ3
KS-1268
LS-1843
M-9651
MCULE-2446846552
MFCD00870168
MLS000028582
MLS000759472
MLS000863291
MLS001148245
MLS001424065
MLS006011958
MolPort-003-848-295
MolPort-006-069-284
NC00126
NCGC00018268-02
NCGC00018268-03
NCGC00089812-03
NCGC00274068-01
NCGC00274068-02
NCGC00274068-07
NE57775
NSC-759239
NSC759239
Opera_ID_902
Oriconazole
Oriconazole, R51211, Sporanox
Pharmakon1600-01505756
PubChem16053
Q-201261
R 51211
R-51211
R51211
s2476
SAM001246679
SBI-0206914.P001
SCHEMBL16984893
SCHEMBL23934
SCHEMBL95627
SMR000058959
SMR001827898
Sporal
Sporanos
Sporanox
Sporanox (TN)
Sporanox(TM)
Sporonox
SR-01000003153
SR-01000003153-5
SR-01000003153-6
ST24025102
STL450986
SW219756-1
TL8005525
Tox21_110854
Tox21_110854_1
trans Itraconazole
Triasporn
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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	AA	RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Mylan Pharms Inc	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	200463-001	Jul 20, 2012	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Accord Hlthcare	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	205991-001	May 26, 2016	AB	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

Expired US Patents for itraconazole

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	ONMEL	itraconazole	TABLET;ORAL	022484-001	Apr 29, 2010	Start Trial	Start Trial
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	Start Trial	Start Trial
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083-001	Sep 11, 1992	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for itraconazole

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Country	Patent Number	Estimated Expiration
European Patent Office	2415462	Start Trial
Canada	2876909	Start Trial
European Patent Office	2863911	Start Trial
>Country	>Patent Number	>Estimated Expiration

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