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Serving leading biopharmaceutical companies globally:

Chubb
Boehringer Ingelheim
Johnson and Johnson
US Army
Harvard Business School
Citi
McKesson
Accenture
Cerilliant
AstraZeneca

Generated: November 24, 2017

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Miconazole - Generic Drug Details

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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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Miconazole has twenty-four patent family members in fourteen countries.

There are twenty-eight drug master file entries for miconazole. One supplier is listed for this compound.

Pharmacology for miconazole

Ingredient-typeAzoles
Drug ClassAzole Antifungal
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
G And W Labs Inc
MICONAZOLE NITRATE
miconazole nitrate
CREAM;VAGINAL074366-001Feb 22, 1996OTCNoNo► Subscribe► Subscribe► Subscribe
G And W Labs
MICONAZOLE 7 COMBINATION PACK
miconazole nitrate
CREAM, SUPPOSITORY;TOPICAL, VAGINAL076585-001Mar 26, 2004OTCNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
VUSION
miconazole nitrate; petrolatum, white; zinc oxide
OINTMENT;TOPICAL021026-001Feb 16, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Actavis Pharma
MICONAZOLE NITRATE
miconazole nitrate
SUPPOSITORY;VAGINAL073508-001Nov 19, 1993ABRXNoNo► Subscribe► Subscribe► Subscribe
Medtech Products
MONISTAT 3
miconazole nitrate
SUPPOSITORY;VAGINAL018888-001Aug 15, 1984ABRXYesYes► Subscribe► Subscribe► Subscribe
Medtech Products
MONISTAT 7
miconazole nitrate
SUPPOSITORY;VAGINAL018520-002Feb 15, 1991OTCYesYes► Subscribe► Subscribe► Subscribe
Actavis Mid Atlantic
M-ZOLE 3 COMBINATION PACK
miconazole nitrate
CREAM, SUPPOSITORY;TOPICAL, VAGINAL074926-001Apr 16, 1999OTCNoNo► Subscribe► Subscribe► Subscribe
Personal Prods
MONISTAT 5
miconazole nitrate
TAMPON;VAGINAL018592-001Oct 27, 1989DISCNNoNo► Subscribe► Subscribe► Subscribe
Perrigo
MICONAZOLE NITRATE COMBINATION PACK
miconazole nitrate
CREAM, SUPPOSITORY;TOPICAL, VAGINAL075329-001Apr 20, 1999OTCNoNo► Subscribe► Subscribe► Subscribe
Midatech Pharma Us
ORAVIG
miconazole
TABLET;BUCCAL022404-001Apr 16, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: miconazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharma
MONISTAT
miconazole
INJECTABLE;INJECTION018040-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Janssen Pharma
MONISTAT
miconazole
INJECTABLE;INJECTION018040-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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International Patent Family for Ingredient: miconazole

Country Document Number Estimated Expiration
Hong Kong1107516► Subscribe
Japan2010270142► Subscribe
Portugal1792610► Subscribe
Germany60222557► Subscribe
World Intellectual Property Organization (WIPO)03009800► Subscribe
Denmark1408911► Subscribe
Canada2455633► Subscribe
Spain2294170► Subscribe
France2827517► Subscribe
China101524337► 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 leading biopharmaceutical companies globally:

UBS
Covington
Queensland Health
Cipla
Farmers Insurance
Moodys
Express Scripts
Fuji
Daiichi Sankyo
Dow

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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