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-seven 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: | 47 |
| Raw Ingredient (Bulk) Api Vendors: | 125 |
| Clinical Trials: | 7 |
| Patent Applications: | 5,387 |
| 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 |
| Biolab Sanus Farmaceutica | Phase 2 |
Pharmacology for miconazole nitrate
| Drug Class | Azole Antifungal |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan | VUSION | miconazole nitrate; white petrolatum; zinc oxide | OINTMENT;TOPICAL | 021026-001 | Feb 16, 2006 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| P And L | MICONAZOLE NITRATE | miconazole nitrate | SUPPOSITORY;VAGINAL | 073507-001 | Nov 19, 1993 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Taro | MICONAZOLE 3 | miconazole nitrate | CREAM;VAGINAL | 076773-001 | Mar 2, 2005 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Medtech Products | MONISTAT 3 COMBINATION PACK | miconazole nitrate | CREAM, SUPPOSITORY;TOPICAL, VAGINAL | 020670-002 | Apr 16, 1996 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| P And L | MICONAZOLE 7 | miconazole nitrate | CREAM;VAGINAL | 074164-001 | Mar 29, 1996 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Insight Pharms | MONISTAT-DERM | miconazole nitrate | CREAM;TOPICAL | 017494-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| Insight Pharms | MONISTAT-DERM | miconazole nitrate | CREAM;TOPICAL | 017494-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| Medtech Products | MONISTAT 1 COMBINATION PACK | miconazole nitrate | CREAM, INSERT;TOPICAL, VAGINAL | 021308-001 | Jun 29, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Medtech Products | MONISTAT 3 | miconazole nitrate | SUPPOSITORY;VAGINAL | 018888-001 | Aug 15, 1984 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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