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Serving 500+ biopharmaceutical companies globally:

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Express Scripts
Fish and Richardson
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Generated: September 21, 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 patent family members in fourteen countries.

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

Summary for Generic Name: miconazole

Tradenames:19
Patents:5
Applicants:15
NDAs:32
Drug Master File Entries: see list28
Suppliers / Packagers: see list1
Bulk Api Vendors: see list66
Clinical Trials: see list21
Patent Applications: see list5,561
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:miconazole at DailyMed

Pharmacology for Ingredient: 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
Insight Pharms
MONISTAT-DERM
miconazole nitrate
LOTION;TOPICAL017739-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Janssen Pharma
MONISTAT
miconazole
INJECTABLE;INJECTION018040-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Perrigo R And D
MICONAZOLE NITRATE
miconazole nitrate
CREAM;VAGINAL091366-001Jan 15, 2010OTCNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms
MICONAZOLE NITRATE
miconazole nitrate
CREAM;VAGINAL074030-001Oct 30, 1992DISCNNoNo► Subscribe► Subscribe► Subscribe
Actavis Mid Atlantic
M-ZOLE 3 COMBINATION PACK
miconazole nitrate
CREAM, SUPPOSITORY;TOPICAL, VAGINAL074926-001Apr 16, 1999OTCNoNo► Subscribe► Subscribe► Subscribe
Medtech Products
MONISTAT 3
miconazole nitrate
SUPPOSITORY;VAGINAL018888-001Aug 15, 1984ABRXYesYes► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
VUSION
miconazole nitrate; petrolatum, white; zinc oxide
OINTMENT;TOPICAL021026-001Feb 16, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
G And W Labs
MICONAZOLE NITRATE
miconazole nitrate
SUPPOSITORY;VAGINAL074414-001Apr 30, 1997OTCNoNo► Subscribe► Subscribe► Subscribe
Medtech Products
MONISTAT 3 COMBINATION PACK
miconazole nitrate
CREAM, SUPPOSITORY;TOPICAL, VAGINAL020670-002Apr 16, 1996OTCYesYes► Subscribe► Subscribe► Subscribe
Personal Prods
MONISTAT 5
miconazole nitrate
TAMPON;VAGINAL018592-001Oct 27, 1989DISCNNoNo► Subscribe► Subscribe► 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
Israel159842► Subscribe
Denmark1792610► Subscribe
Portugal1792610► Subscribe
Cyprus1108796► Subscribe
World Intellectual Property Organization (WIPO)03009800► Subscribe
Germany60222557► Subscribe
Spain2316108► Subscribe
Austria411003► Subscribe
Spain2294170► 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 500+ biopharmaceutical companies globally:

Farmers Insurance
Teva
Express Scripts
Covington
Cantor Fitzgerald
US Department of Justice
Medtronic
Cipla
Healthtrust
US Army

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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