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Miconazole - Generic Drug Details

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

Miconazole is the generic ingredient in nineteen branded drugs marketed by Janssen Pharma, Midatech Pharma Us, Actavis Mid Atlantic, G And W Labs, Perrigo R And D, Perrigo, Medtech Products, Insight Pharms, Taro, G And W Labs Inc, Taro Pharms, Teva, Teva Pharms, Actavis Pharma, Personal Prods, and Mylan Pharms Inc, and is included in thirty-two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Miconazole has twenty-four patent family members in fourteen countries.

There are twenty-eight drug master file entries for miconazole. One supplier is listed for this compound.

Summary for miconazole

International Patents:	24
US Patents:	5
Tradenames:	19
Applicants:	16
NDAs:	32
Drug Master File Entries:	28
Suppliers / Packagers:	1
Bulk Api Vendors:	82
Clinical Trials:	23
Patent Applications:	6,438
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for miconazole
DailyMed Link:	miconazole at DailyMed

Pharmacology for miconazole

Drug Class

Azole Antifungal

Medical Subject Heading (MeSH) Categories for miconazole

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP2C9 Inhibitors

Cytochrome P-450 CYP3A Inhibitors

Synonyms for miconazole

(+-)-1-(2,4-Dichloro-beta-((2,4-dichlorobenzyl)oxy)phenethyl)imidazole

(+/-)-Miconazole nitrate salt

1-(2-((2,4-Dichlorobenzyl)oxy)-2-(2,4-dichlorophenyl)ethyl)-1H-imidazole

1-(2-(2,4-dichlorophenyl)-2-((2,4-dichlorophenyl)methoxy)ethyl)-imidazol

1-(2,4-dichloro-beta-((2,4-dichlorobenzyl)oxy)phenethyl) imidazole

1-(2,4-Dichloro-beta-((2,4-dichlorobenzyl)oxy)phenethyl)imidazole

1-(2,4-Dichloro-beta-[(2,4-dichlorobenzyl)oxy]phenethyl)imidazole

1-(2,4-dichlorophenyl)-1-[(2,4-dichlorophenyl)methoxy]-2-imidazolylethane

1-[2-(2,4-Dichloro-benzyloxy)-2-(2,4-dichloro-phenyl)-ethyl]-1H-imidazole

1-[2-(2,4-dichlorobenzyl)oxy-2-(2,4-dichlorophenyl)ethyl]imidazole;nitric acid

1-[2-(2,4-dichlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole

1-[2-(2,4-dichlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl]imidazole

1-[2-(2,4-Dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]-1H-imidazole

1-[2-(2,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]imidazole

1-[2-(2,4-dichlorophenyl)-2-{[(2,4-dichlorophenyl)methyl]oxy}ethyl]-1H-imidazole

1-[2-[(2,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole

1-[2-[(2,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole #

1-[2,4-Dichloro- beta-([2,4-dichloro- benzyl]oxy)phenethyl]imidazole

1-[2,4-Dichloro-.beta.-[(2,4-dichlorobenzyl)oxy]phenethyl]imidazole

1-[2,4-Dichloro-beta-([2,4-dichloro-benzyl]oxy)phenethyl]imidazole

1-[2,4-Dichloro-beta-([2,4-dichlorobenzyl]oxy)-phenethyl] imidazole

1-[2,4-dichloro-beta-(2,4-dichlorobenzyloxy)-phenethyl]imidazole

1-[2,4-dichloro-beta-(2,4-dichlorobenzyloxy)phenethyl]-imidazole

1-[2,4-dichloro-beta-(2,4-dichlorobenzyloxy)phenethyl]imidazole

1-[2,4dichloro-beta-(2,4-dichlorobenzyloxy)phenethyl]imidazole

1-{2-[(2,4-dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl}-1H-imidazole

1H-imidazole, 1-(2-(2,4-dichlorophenyl)-2-((2,4-dichlorophenyl) methoxy)ethyl)-

1H-Imidazole, 1-(2-(2,4-dichlorophenyl)-2-((2,4-dichlorophenyl)methoxy)ethyl)-

1H-Imidazole, 1-[2-(2,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]-

1H-Imidazole, 1-2-((2,4-dichlorophenyl)-2-((2,4-dichlorophenyl))methoxy)ethyl)-, (+-)-

1H-Imidazole,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]-

216M019

22832-87-7 (NITRATE)

22916-47-8

4CH-014451

75319-47-0

AB00053500

AB00053500_26

AB00053500_27

AB00053500_28

AB00053500-23

AB00053500-24

AB00053500-25

AB0023582

AB2000633

AC1L1HM1

AE-641/01941016

Aflorix(nitrate)

AK-34234

AKOS001574474

Albistat(nitrate)

Andergin(nitrate)

ANW-42336

API0003382

AX8055353

BDBM31772

bmse000924

BPBio1_000279

BRD-A82396632-001-03-0

BRD-A82396632-008-02-7

Brentan

BRN 0965511

BSPBio_000253

BSPBio_002033

BYBLEWFAAKGYCD-UHFFFAOYSA-N

C-28730

C18H14Cl4N2O

CAS-22916-47-8

CC-03621

CCG-220067

CCRIS 7924

CHEBI:82892

CHEMBL91

cid_4189

Conofite(nitrate)

CS-2565

CTK8B3340

D00416

D00AXJ

Dactarin

Daktarin

Daktarin (TN)

Daktarin IV

Daktarin IV; MJR 1762; Monistat IV; NSC 17098

DB-046018

DB01110

Desenex, Monistat, Zeasorb-AF

DivK1c_000156

DL-448

DS-1881

DSSTox_CID_3319

DSSTox_GSID_23319

DSSTox_RID_76975

DTXSID6023319

EINECS 245-324-5

Epi-Monistat(nitrate)

Femizol (TN)

Femizol-M

Florid(nitrate)

FT-0628942

GA8311

GTPL2449

Gyno-Daktar(nitrate)

HE020852

HE326912

HMS1568M15

HMS2090B21

HMS2095M15

HMS2232B14

HMS3374J10

HMS3656E14

HY-B0454

I14-14342

IDI1_000156

imidazole, 1-(2-(2,4-dichlorophenyl)-2-((2,4-dichlorophenyl) methoxy)ethyl)- (9CI)

Imidazole, 1-(2-(2,4-dichlorophenyl)-2-((2,4-dichlorophenyl) methoxy)ethyl)-(9CI)

Imidazole, 1-(2-(2,4-dichlorophenyl)-2-((2,4-dichlorophenyl)methoxy)ethyl)-

Imidazole, 1-(2-(2,4-dichlorophenyl)-2-((2,4-dichlorophenyl)methoxy)ethyl)- (9CI)

Imidazole, 1-(2-(2,4-dichlorophenyl)-2-((2,4-dichlorophenyl)methoxy)ethyl)-(9CI)

Imidazole, 1-(2,4-dichloro-.beta.-((2,4-dichlorobenzyl)oxy)phenethyl)-

imidazole, 1-(2,4-dichloro-beta-((2,4-dichlorobenzyl)oxy) phenethyl)-

Imidazole, 1-(2,4-dichloro-beta-((2,4-dichlorobenzyl)oxy)phenethyl)-

Imidazole,4-dichloro-.beta.-[(2,4-dichlorobenzyl)oxy]phenethyl]-

J-014898

J10390

KB-216913

KBio1_000156

KBio2_001445

KBio2_004013

KBio2_006581

KBio3_001533

KBioGR_000581

KBioSS_001445

KS-00000M1G

Lotrimin AF(nitrate)

LS-78378

M-4631

M-zole 3 Combination Pack

MCULE-2106181573

MCZ

MFCD00216019

Micantin (nitrate)

Micatin (TN)

Miconasil Nitrate

Miconazex (TN)

Miconazol

Miconazol [INN-Spanish]

Miconazole (JP15/USP/INN)

Miconazole (JP17/USP/INN)

Miconazole (Monistat)

Miconazole [USAN:BAN:INN:JAN]

Miconazole [USP:INN:BAN:JAN]

Miconazole 3

Miconazole 3 Combination Pack

Miconazole 7

Miconazole 7 Combination Pack

Miconazole Base

Miconazole nitrate salt

Miconazole-7

Miconazolo

Miconazolo [DCIT]

Miconazolum

Miconazolum [INN-Latin]

Micozole

Minostate

MJR 1762

MLS002222203

MolPort-002-557-553

Monazole 7

Monista (nitrate)

Monistat

Monistat (TN)

Monistat 1 Combination Pack

Monistat 3

Monistat 3 Combination Pack

Monistat 3 Dual-Pak

Monistat 3 Vaginal Ovules

Monistat 5

Monistat 5 Tampon

Monistat 7

Monistat 7 Dual-Pak

Monistat 7 Vaginal Suppositories

Monistat Dual- PAK

Monistat Dual-pak

Monistat IV

Monistat iv (TN)

Monistat-Derm

Monistat-Derm (TN)

NCGC00016770-01

NCGC00018294-02

NCGC00018294-04

NCGC00018294-06

NCI60_001353

NCI60_001380

NINDS_000156

Novo-Miconazole Vaginal Ovules

NSC 170986

NSC-170986

NSC169434

NSC170986

Oprea1_091955

Oravig

Prestwick_335

Prestwick0_000067

Prestwick1_000067

Prestwick2_000067

Prestwick3_000067

R 18134

R-14,889

R-14889

s2536

SBB057453

SBI-0051448.P003

SC-19243

SCHEMBL13934598

SCHEMBL2866

SMR001307249

SPBio_000976

SPBio_002174

Spectrum_000965

Spectrum2_001048

Spectrum3_000507

Spectrum4_000061

Spectrum5_001297

ST024747

ST2413510

STK834405

STOCK1S-93556

TC-131081

Tox21_110601

Vusion

W4662

Zimybase

Zimycan

US Patents and Regulatory Information for miconazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
G And W Labs Inc	MICONAZOLE NITRATE	miconazole nitrate	CREAM;VAGINAL	074366-001	Feb 22, 1996		OTC	No	No
Actavis Pharma	MICONAZOLE NITRATE	miconazole nitrate	SUPPOSITORY;VAGINAL	073507-001	Nov 19, 1993		OTC	No	No
Medtech Products	MONISTAT 7 COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	020288-002	Apr 26, 1993		OTC	Yes	Yes
Taro Pharms	MICONAZOLE NITRATE	miconazole nitrate	CREAM;VAGINAL	074444-001	Jan 13, 1997		OTC	No	No
Perrigo	MICONAZOLE NITRATE COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	075329-001	Apr 20, 1999		OTC	No	No
Actavis Pharma	MICONAZOLE NITRATE	miconazole nitrate	SUPPOSITORY;VAGINAL	073508-001	Nov 19, 1993	AB	RX	No	No
Janssen Pharma	MONISTAT	miconazole	INJECTABLE;INJECTION	018040-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for miconazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharma	MONISTAT	miconazole	INJECTABLE;INJECTION	018040-001	Approved Prior to Jan 1, 1982
Janssen Pharma	MONISTAT	miconazole	INJECTABLE;INJECTION	018040-001	Approved Prior to Jan 1, 1982

International Patents for miconazole

Country	Document Number	Estimated Expiration
Japan	2010270142
Germany	60229456
France	2827517
Cyprus	1108796
Japan	4657603
Austria	373464
European Patent Office	1792610