Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

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Miconazole nitrate - Generic Drug Details

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

Miconazole nitrate is the generic ingredient in seventeen branded drugs marketed by P And L, Actavis Mid Atlantic, Acp Nimble, Perrigo R And D, Perrigo, Medtech Products, Insight Pharms, Taro, Taro Pharms, Teva, Teva Pharms, Actavis Pharma, Personal Prods, and Mylan, and is included in thirty NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Miconazole nitrate has sixteen patent family members in thirteen countries.

There are twenty-eight drug master file entries for miconazole nitrate. Fifty suppliers are listed for this compound.

Drug Prices for miconazole nitrate

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Drug Sales Revenue Trends for miconazole nitrate

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Recent Clinical Trials for miconazole nitrate

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

SponsorPhase
Population CouncilPhase 1
Biolab Sanus FarmaceuticaPhase 2
Galeno Desenvolvimento de Pesquisas ClĂ­nicasPhase 2

See all miconazole nitrate clinical trials

Pharmacology for miconazole nitrate
Synonyms for miconazole nitrate
( inverted exclamation markA)-Miconazole nitrate salt
(+-)-Miconazole nitrate
(+/-)-MICONAZOLE NITRATE
(+/-)-Miconazole nitrate salt
(+/-)-Miconazole nitrate salt, imidazole antibiotic
(+/-)-Miconazole nitrate salt, Pharmaceutical Secondary Standard; Certified Reference Material
(+/-)-Miconazole, Nitrate
[2,4-dichlorobenzyloxy)phenethyl]imidazole nitrate
1-(2-((2,4-dichlorobenzyl)oxy)-2-(2,4-dichlorophenyl)ethyl)-1H-imidazole nitrate
1-(2-(2,4-dichlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl)-1H-imidazole nitrate
1-(2,4-Dichloro-beta-((2,4-dichlorobenzyl)oxy)phenethyl)imidazole mononitrate
1-(2,4-DICHLORO-BETA-[(2,4-DICHLOROBENZYL)OXY]PHENETHYL)IMIDAZOLE NITRATE
1-[2-(2,4-Dichlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole Nitrate
1-[2-(2,4-Dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]-1H-imidazole Nitrate
1-[2-(2,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]imidazole; nitric acid
1-[2-(2,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]imidazole;nitric acid
1-[2-(2,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]imidazole;nitric acid.
1-[2,4-Dichloro beta-([2,4-dichloro- benzyl]oxy]phenethyl]imidazole
1-[2,4-Dichloro beta-([2,4-dichloro-benzyl]oxy]phenethyl]imidazole
1-[2,4-Dichloro-b-[(2,4-dichlorobenzyl)oxy]phenethyl]imidazole mononitrate
1-[2,4-dichlorobenzyl)oxy]phenethyl]imidazole mononitrate
1H-Imidazole, 1-(2-(2,4-dichlorophenyl)-2-((2,4-dichlorophenyl)methoxy)ethyl)-, mononitrate
1H-Imidazole,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]-, mononitrate
22832-37-7
22832-87-7
22916-47-8 (Parent)
75319-48-1
AB0013871
AB02339
AB1009562
AC1L29ZG
AC1Q21VU
AC1Q59XS
ACM22832377
Aflorix
AKOS015895065
AKOS015962190
Albistat
Aluminum hydroxideoxide (Al(OH)O), hydrate (9CI)
AN-17946
Andergin
API0003383
AS-13575
AX8049689
BC209991
BCP13696
Brentan
C08070
C18H15Cl4N3O4
CCG-39756
CHEMBL1559
component of Monistat cream
Conofite
CPD000058733
Crimak
CS-2881
CTK8F1498
D00882
Daktarin
Daktarin talc
Deralbine
Dermonistat
EBD15554
EBD3317250
EINECS 245-256-6
Epi-Monistat
Florid
FT-0628943
FT-0628944
Fungisdin
Gyno-Daktar
Gyno-Daktarin
Gyno-Monistat
HMS1920N21
HMS2091F16
HMS2233O22
HMS3259M05
HMS3655D05
HMS500H18
HY-B0454A
I06-0472
I742
Imidazole, 1-(2,4-dichloro-beta-((2,4-dichlorobenzyl)oxy)phenethyl)-, mononitrate
Imidazole,4-dichloro-.beta.-[(2,4-dichlorobenzyl)oxy]phenethyl]-, mononitrate
J-014876
J10381
Lotrimin AF Jock-Itch Powder Aerosol
Lotrimin AF Powder
Lotrimin AF Powder Aerosol
Lotrimin AF Spray Liquid
LS-78379
M-206
M-zole 3 Combination Pack
M-zole 7 Dual Pack
M1769
MCCACAIVAXEFAL-UHFFFAOYSA-N
Mezolitan
MFCD00058161
Micatin
Micatin (TN)
Miconal Ecobi
Miconazol Nitrate
Miconazole (nitrate)
Miconazole 1
Miconazole 3 Combination Pack
Miconazole 7
Miconazole nitrate (JP17/USP)
Miconazole nitrate [USAN:JAN]
Miconazole nitrate [USAN:USP:JAN]
Miconazole Nitrate Combination Pack
Miconazole nitrate salt
Miconazole Nitrate USP
Miconazole nitrate, British Pharmacopoeia (BP) Reference Standard
Miconazole nitrate, European Pharmacopoeia (EP) Reference Standard
Miconazole nitrate, United States Pharmacopeia (USP) Reference Standard
Miconazole Nitrate,(S)
miconazole; nitric acid
Micotef
MLS000028674
MLS001148223
MLS002548903
MolPort-003-665-537
Monistat (TN)
Monistat 3
Monistat 3 Combination Pack
Monistat 3 combination pack (prefilled)
Monistat 5
Monistat 7
Monistat 7 Combination Pack
Monistat Cream & Suppositories
Monistat Dual- PAK
Monistat Dual-pak
Monistat nitrate
Monistat-3 Combination Pack
NC00461
NCGC00094728-01
NCGC00094728-02
NCGC00094728-03
NSC 169434
NSC-169434
NSC-757119
NSC169434
NSC757119
Opera_ID_1059
Pharmakon1600-01500413
R 14,889
R 14889
R-14889
REGID_for_CID_68553
s1956
SAM002264623
SBB057009
SCHEMBL15799
SMR000058733
SPECTRUM1500413
SR-01000000271
SR-01000000271-2
ST24048105
SW196614-3
TRA0048650
Vusion
ZX-AFC003200
Paragraph IV (Patent) Challenges for MICONAZOLE NITRATE
Tradename Dosage Ingredient NDA Submissiondate
MONISTAT 1 COMBINATION PACK CREAM, SUPPOSITORY;TOPICAL, VAGINAL miconazole nitrate 021308 2007-12-05

US Patents and Regulatory Information for miconazole nitrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medtech Products MONISTAT 1 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 021308-001 Jun 29, 2001 OTC Yes Yes   Start Trial   Start Trial Y   Start Trial
Insight Pharms MONISTAT-DERM miconazole nitrate LOTION;TOPICAL 017739-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Actavis Mid Atlantic M-ZOLE 7 DUAL PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 074586-001 Jul 17, 1997 DISCN 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 miconazole nitrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medtech Products MONISTAT 3 miconazole nitrate SUPPOSITORY;VAGINAL 018888-001 Aug 15, 1984   Start Trial   Start Trial
Medtech Products MONISTAT 1 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 021308-001 Jun 29, 2001   Start Trial   Start Trial
Medtech Products MONISTAT 3 miconazole nitrate SUPPOSITORY;VAGINAL 018888-001 Aug 15, 1984   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Baxter

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