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Last Updated: April 10, 2020

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Itraconazole - Generic Drug Details

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What are the generic sources for itraconazole and what is the scope of patent protection?

Itraconazole is the generic ingredient in four branded drugs 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, Janssen Pharms, Mayne Pharma Intl, Apotex, 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-four patent family members in twelve countries.

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

Drug Prices for itraconazole

See drug prices for itraconazole

Recent Clinical Trials for itraconazole

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

SponsorPhase
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
TherapeuticsMDPhase 1
Yonsei UniversityPhase 4

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
Torrent ITRACONAZOLE itraconazole CAPSULE;ORAL 209460-001 Aug 24, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex ITRACONAZOLE itraconazole SOLUTION;ORAL 208481-001 Aug 2, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Mayne Pharma Intl TOLSURA itraconazole CAPSULE;ORAL 208901-001 Dec 11, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Zydus Pharms ITRACONAZOLE itraconazole CAPSULE;ORAL 204672-001 Sep 19, 2017 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
Janssen Pharms SPORANOX itraconazole SOLUTION;ORAL 020657-001 Feb 21, 1997 AA RX Yes Yes   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

Expired US Patents for itraconazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992   Start Trial   Start Trial
Janssen Pharms SPORANOX itraconazole SOLUTION;ORAL 020657-001 Feb 21, 1997   Start Trial   Start Trial
Janssen Pharms SPORANOX itraconazole INJECTABLE;INJECTION 020966-001 Mar 30, 1999   Start Trial   Start Trial
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992   Start Trial   Start Trial
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010   Start Trial   Start Trial
Janssen Pharms SPORANOX itraconazole INJECTABLE;INJECTION 020966-001 Mar 30, 1999   Start Trial   Start Trial
Janssen Pharms SPORANOX itraconazole SOLUTION;ORAL 020657-001 Feb 21, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Harvard Business School
Dow
Boehringer Ingelheim
Mallinckrodt
Moodys
McKinsey

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