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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 Clínicas | 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.