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Miconazole nitrate - Generic Drug Details

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Miconazole nitrate is the generic ingredient in seventeen branded drugs marketed by Actavis Mid Atlantic, Medtech Products, Perrigo R And D, G And W Labs, Perrigo, Teva Pharms, Teva, Insight Pharms, Taro, G And W Labs Inc, Personal Prods, and Delcor Asset Corp, and is included in thirty NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has fourteen patent family members in twelve countries.

There are twenty-eight drug master file entries for miconazole nitrate. Fifty-four suppliers are listed for this compound.

Summary for Generic Name: miconazole nitrate

Tradenames:17
Patents:2
Applicants:12
NDAs:30
Drug Master File Entries: see list28
Suppliers / Packaging: see list54
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: miconazole nitrate

Ingredient-typeAzoles
Drug ClassAzole Antifungal
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medtech Products
MONISTAT 7 COMBINATION PACK
miconazole nitrate
CREAM, SUPPOSITORY;TOPICAL, VAGINAL020288-002Apr 26, 1993OTCYes► subscribe► subscribe
Medtech Products
MONISTAT 7
miconazole nitrate
SUPPOSITORY;VAGINAL018520-002Feb 15, 1991OTCYes► subscribe► subscribe
Medtech Products
MONISTAT 1 COMBINATION PACK
miconazole nitrate
CREAM, SUPPOSITORY;TOPICAL, VAGINAL021308-001Jun 29, 2001OTCYes6,153,635► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: miconazole nitrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medtech Products
MONISTAT 1 COMBINATION PACK
miconazole nitrate
CREAM, SUPPOSITORY;TOPICAL, VAGINAL021308-001Jun 29, 20015,514,698► subscribe
Insight Pharms
MONISTAT-DERM
miconazole nitrate
LOTION;TOPICAL017739-001Approved Prior to Jan 1, 19823,839,574► subscribe
Medtech Products
MONISTAT 3
miconazole nitrate
SUPPOSITORY;VAGINAL018888-001Aug 15, 19843,839,574► subscribe
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International Patent Family for Ingredient: miconazole nitrate

Country Document Number Estimated Expiration
Japan2002530327► subscribe
Australia2024800► subscribe
Hong Kong1036930► 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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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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