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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.
Summary for miconazole nitrate
International Patents: | 16 |
US Patents: | 2 |
Tradenames: | 17 |
Applicants: | 14 |
NDAs: | 30 |
Drug Master File Entries: | 28 |
Suppliers / Packagers: | 50 |
Bulk Api Vendors: | 87 |
Clinical Trials: | 5 |
Patent Applications: | 2,727 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for miconazole nitrate |
DailyMed Link: | miconazole nitrate at DailyMed |
Recent Clinical Trials for miconazole nitrate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Population Council | Phase 1 |
Biolab Sanus Farmaceutica | Phase 2 |
Galeno Desenvolvimento de Pesquisas ClĂnicas | Phase 2 |
Pharmacology for miconazole nitrate
Drug Class | Azole Antifungal |
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 |
International Patents for miconazole nitrate
Country | Patent Number | Estimated Expiration |
---|---|---|
Australia | 2024800 | Start Trial |
Germany | 69930725 | Start Trial |
Australia | 777508 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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