Miconazole - Generic Drug Details
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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, Perrigo R And D, Medtech Products, P And L, Actavis Mid Atlantic, Cosette, L Perrigo Co, Insight Pharms, Perrigo, Taro, Taro Pharms, Teva, Teva Pharms, Actavis Pharma, Personal Prods, and Mylan, and is included in thirty-two NDAs. There are four 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: | 4 |
| Tradenames: | 19 |
| Applicants: | 17 |
| NDAs: | 32 |
| Drug Master File Entries: | 28 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 102 |
| Clinical Trials: | 27 |
| Patent Applications: | 7,061 |
| 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 |
|---|---|
| Aesculape CRO Belgium BV | Phase 2 |
| Hill Dermaceuticals, Inc. | Phase 2/Phase 3 |
| Abond CRO Inc. | Phase 2/Phase 3 |
Pharmacology for miconazole
| Drug Class | Azole Antifungal |
Medical Subject Heading (MeSH) Categories for miconazole
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Insight Pharms | MONISTAT-DERM | miconazole nitrate | LOTION;TOPICAL | 017739-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| P And L | MICONAZOLE 7 | miconazole nitrate | CREAM;VAGINAL | 074164-001 | Mar 29, 1996 | OTC | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Medtech Products | MONISTAT 7 | miconazole nitrate | CREAM;VAGINAL | 017450-002 | Feb 15, 1991 | OTC | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Galt Pharms | ORAVIG | miconazole | TABLET;BUCCAL | 022404-001 | Apr 16, 2010 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Perrigo R And D | MICONAZOLE NITRATE | miconazole nitrate | CREAM;VAGINAL | 091366-001 | Jan 15, 2010 | OTC | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >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 | See Plans and Pricing | See Plans and Pricing |
| Janssen Pharma | MONISTAT | miconazole | INJECTABLE;INJECTION | 018040-001 | Approved Prior to Jan 1, 1982 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for miconazole
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2004537558 | See Plans and Pricing | |
| Spain | 2316108 | See Plans and Pricing | |
| European Patent Office | 1792610 | Systèmes thérapeutiques bioadhésifs à libération prolongée (Sustained release bioadhesive therapeutic systems) | See Plans and Pricing |
| World Intellectual Property Organization (WIPO) | 03009800 | See Plans and Pricing | |
| France | 2827517 | SYSTEMES THERAPEUTIQUES BIOADHESIFS A LIBERATION PROLONGEE | See Plans and Pricing |
| >Country | >Patent Number | >Title | >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 verification 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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