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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 itraconazole freedom to operate?

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, Sandoz, Torrent, Zydus Pharms Usa Inc, Janssen Pharms, Mayne Pharma Intl, and Sebela Ireland Ltd, and is included in sixteen 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-two 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:	32
US Patents:	6
Tradenames:	4
Applicants:	13
NDAs:	16
Drug Master File Entries:	15
Suppliers / Packagers:	20
Bulk Api Vendors:	127
Clinical Trials:	227
Patent Applications:	6,867
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

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

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
Mylan Pharms Inc	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	200463-001	Jul 20, 2012	AB	RX	No	No
Sebela Ireland Ltd	ONMEL	itraconazole	TABLET;ORAL	022484-001	Apr 29, 2010		RX	Yes	Yes			Y
Jubilant Generics	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	203445-001	Feb 23, 2017	AB	RX	No	No
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	AA	RX	Yes	Yes
Mayne Pharma Intl	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes			Y
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999		DISCN	No	No
Mayne Pharma Intl	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes			Y

Expired US Patents for itraconazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083-001	Sep 11, 1992
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083-001	Sep 11, 1992

International Patents for itraconazole

Country	Patent Number	Estimated Expiration
Japan	2009504589
Japan	2015531749
Mexico	2015000179
Japan	5159012
European Patent Office	2863911
Spain	2571032
Hong Kong	1207288