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Generated: July 26, 2017
What are the generic drug sources for miconazole and what is the scope of miconazole patent protection?
Miconazole is the generic ingredient in nineteen branded drugs marketed by Midatech Pharma Us, Janssen Pharma, Actavis Pharma, Medtech Products, Perrigo R And D, G And W Labs, Actavis Mid Atlantic, Perrigo, Teva Pharms, Teva, Insight Pharms, Taro, G And W Labs Inc, Personal Prods, and Mylan Pharms Inc, and is included in thirty-two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 19 |
| Patents: | 6 |
| Applicants: | 15 |
| NDAs: | 32 |
| Drug Master File Entries: see list | 28 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 66 |
| Clinical Trials: see list | 21 |
| Patent Applications: see list | 12,682 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | miconazole at DailyMed |
| Ingredient-type | Azoles |
| Drug Class | Azole Antifungal |
| 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 3 COMBINATION PACK | miconazole nitrate | CREAM, SUPPOSITORY;TOPICAL, VAGINAL | 020670-002 | Apr 16, 1996 | OTC | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Medtech Products | MONISTAT 7 COMBINATION PACK | miconazole nitrate | CREAM, SUPPOSITORY;TOPICAL, VAGINAL | 020288-002 | Apr 26, 1993 | OTC | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Actavis Pharma | MICONAZOLE NITRATE | miconazole nitrate | SUPPOSITORY;VAGINAL | 073508-001 | Nov 19, 1993 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Perrigo | MICONAZOLE NITRATE | miconazole nitrate | CREAM;VAGINAL | 074760-001 | May 15, 1997 | OTC | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Actavis Pharma | MICONAZOLE NITRATE | miconazole nitrate | SUPPOSITORY;VAGINAL | 073507-001 | Nov 19, 1993 | OTC | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| 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 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Janssen Pharma | MONISTAT | miconazole | INJECTABLE;INJECTION | 018040-001 | Approved Prior to Jan 1, 1982 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Portugal | 1408911 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2294170 | ► Subscribe | |||||||||||||||||||||||||||
| China | 101524337 | ► Subscribe | |||||||||||||||||||||||||||
| France | 2827517 | ► Subscribe | |||||||||||||||||||||||||||
| Austria | 411003 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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