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Miconazole - Generic Drug Details
» See Plans and Pricing
What are the generic sources for miconazole and what is the scope of patent protection?
Miconazole
is the generic ingredient in nineteen branded drugs marketed by Janssen Pharma, Galt Pharms, P And L, Actavis Mid Atlantic, Cosette, 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-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.
Summary for miconazole
| International Patents: | 24 |
| US Patents: | 5 |
| Tradenames: | 19 |
| Applicants: | 16 |
| NDAs: | 32 |
| Drug Master File Entries: | 28 |
| Bulk Api Vendors: | 93 |
| Clinical Trials: | 26 |
| Patent Applications: | 4,535 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for miconazole |
| What excipients (inactive ingredients) are in miconazole? | miconazole excipients list |
| DailyMed Link: | miconazole at DailyMed |
Recent Clinical Trials for miconazole
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Abond CRO Inc. | Phase 2/Phase 3 |
| Hill Dermaceuticals, Inc. | Phase 2/Phase 3 |
| William N Handelman | Phase 2 |
Medical Subject Heading (MeSH) Categories for miconazole
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Perrigo R And D | MICONAZOLE NITRATE | miconazole nitrate | CREAM;VAGINAL | 091366-001 | Jan 15, 2010 | OTC | No | No | Start Trial | Start Trial | Start Trial | ||||
| Perrigo | MICONAZOLE NITRATE | miconazole nitrate | CREAM;VAGINAL | 074760-001 | May 15, 1997 | OTC | No | No | Start Trial | Start Trial | Start Trial | ||||
| Mylan | VUSION | miconazole nitrate; petrolatum, white; zinc oxide | OINTMENT;TOPICAL | 021026-001 | Feb 16, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Perrigo | MICONAZOLE NITRATE | miconazole nitrate | SUPPOSITORY;VAGINAL | 074395-001 | Mar 20, 1997 | OTC | No | Yes | Start Trial | Start Trial | Start Trial | ||||
| Taro | MICONAZOLE 3 | miconazole nitrate | CREAM;VAGINAL | 076773-001 | Mar 2, 2005 | OTC | 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
| 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 | Start Trial | Start Trial |
| Janssen Pharma | MONISTAT | miconazole | INJECTABLE;INJECTION | 018040-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for miconazole
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2316108 | Start Trial |
| Spain | 2294170 | Start Trial |
| Portugal | 1792610 | Start Trial |
| European Patent Office | 1792610 | Start Trial |
| Germany | 60229456 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
