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, P And L, Actavis Mid Atlantic, Cosette, L Perrigo Co, Insight Pharms, Perrigo, Taro, 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. Forty-nine 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: | 49 |
Raw Ingredient (Bulk) Api Vendors: | 125 |
Clinical Trials: | 7 |
Patent Applications: | 5,050 |
Formulation / Manufacturing: | see details |
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 ClĂnicas | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Medtech Products | MONISTAT 7 | miconazole nitrate | CREAM;VAGINAL | 017450-002 | Feb 15, 1991 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Perrigo | MICONAZOLE NITRATE | miconazole nitrate | SUPPOSITORY;VAGINAL | 074395-001 | Mar 20, 1997 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Cosette | MICONAZOLE NITRATE | miconazole nitrate | CREAM;VAGINAL | 074366-001 | Feb 22, 1996 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Cosette | MICONAZOLE 7 COMBINATION PACK | miconazole nitrate | CREAM, SUPPOSITORY;TOPICAL, VAGINAL | 076585-001 | Mar 26, 2004 | DISCN | No | No | ⤷ 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 | LOTION;TOPICAL | 017739-001 | Approved Prior to Jan 1, 1982 | ⤷ 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 |
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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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