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 Perrigo R And D, Medtech Products, Cosette, Actavis Mid Atlantic, L Perrigo Co, Insight Pharms, Perrigo, Taro, P And L, Teva, Teva Pharms, Actavis Pharma, Personal Prods, and Mylan, and is included in thirty NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.There are seventeen drug master file entries for miconazole nitrate. Fifty-one suppliers are listed for this compound.
Summary for MICONAZOLE NITRATE
| US Patents: | 1 |
| Tradenames: | 17 |
| Applicants: | 14 |
| NDAs: | 30 |
| Drug Master File Entries: | 17 |
| Finished Product Suppliers / Packagers: | 51 |
| Raw Ingredient (Bulk) Api Vendors: | 125 |
| Clinical Trials: | 7 |
| Patent Applications: | 5,050 |
| Drug Prices: | Drug price trends for MICONAZOLE NITRATE |
| What excipients (inactive ingredients) are in MICONAZOLE NITRATE? | MICONAZOLE NITRATE excipients list |
| DailyMed Link: | MICONAZOLE NITRATE at DailyMed |
Recent Clinical Trials for MICONAZOLE NITRATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Aesculape CRO Belgium BV | Phase 2 |
| Population Council | Phase 1 |
| Galeno Desenvolvimento de Pesquisas Clínicas | Phase 2 |
Pharmacology for MICONAZOLE NITRATE
| Drug Class | Azole Antifungal |
Anatomical Therapeutic Chemical (ATC) Classes for MICONAZOLE NITRATE
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Pharma | MICONAZOLE NITRATE | miconazole nitrate | SUPPOSITORY;VAGINAL | 073508-001 | Nov 19, 1993 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Taro | MICONAZOLE 3 | miconazole nitrate | CREAM;VAGINAL | 076773-001 | Mar 2, 2005 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| P And L | MICONAZOLE 7 | miconazole nitrate | CREAM;VAGINAL | 074164-001 | Mar 29, 1996 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Medtech Products | MONISTAT 3 COMBINATION PACK | miconazole nitrate | CREAM, SUPPOSITORY;TOPICAL, VAGINAL | 020670-002 | Apr 16, 1996 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Perrigo R And D | MICONAZOLE NITRATE | miconazole nitrate | CREAM;VAGINAL | 091366-001 | Jan 15, 2010 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Perrigo R And D | MICONAZOLE NITRATE | miconazole nitrate | CREAM, INSERT;TOPICAL, VAGINAL | 079114-001 | Jun 2, 2010 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Medtech Products | MONISTAT 3 | miconazole nitrate | CREAM;VAGINAL | 020827-001 | Mar 30, 1998 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 |
|---|---|---|---|---|---|---|---|
| Insight Pharms | MONISTAT-DERM | miconazole nitrate | CREAM;TOPICAL | 017494-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Medtech Products | MONISTAT 3 | miconazole nitrate | SUPPOSITORY;VAGINAL | 018888-001 | Aug 15, 1984 | ⤷ Sign Up | ⤷ Sign Up |
| Medtech Products | MONISTAT 1 COMBINATION PACK | miconazole nitrate | CREAM, INSERT;TOPICAL, VAGINAL | 021308-001 | Jun 29, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Insight Pharms | MONISTAT-DERM | miconazole nitrate | LOTION;TOPICAL | 017739-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Medtech Products | MONISTAT 3 | miconazole nitrate | SUPPOSITORY;VAGINAL | 018888-001 | Aug 15, 1984 | ⤷ Sign Up | ⤷ Sign Up |
| Insight Pharms | MONISTAT-DERM | miconazole nitrate | CREAM;TOPICAL | 017494-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Insight Pharms | MONISTAT-DERM | miconazole nitrate | LOTION;TOPICAL | 017739-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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.
ISSN: 2162-2639
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