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Serving 500+ biopharmaceutical companies globally:

Citi
Chinese Patent Office
Boehringer Ingelheim
Queensland Health
Cipla
AstraZeneca
Fish and Richardson
Accenture
McKesson
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Generated: June 27, 2017

DrugPatentWatch Database Preview

MONISTAT Drug Profile

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What is the patent landscape for Monistat, and when can generic versions of Monistat launch?

Monistat is a drug marketed by Janssen Pharma, Medtech Products, Personal Prods, and Insight Pharms. and is included in twelve NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in MONISTAT is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.

Summary for Tradename: MONISTAT

Patents:0
Applicants:4
NDAs:12
Bulk Api Vendors: see list65
Clinical Trials: see list1
Patent Applications: see list5,893
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:MONISTAT at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharma
MONISTAT
miconazole
INJECTABLE;INJECTION018040-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Medtech Products
MONISTAT 3 COMBINATION PACK (PREFILLED)
miconazole nitrate
CREAM;TOPICAL, VAGINAL021261-001Feb 2, 2001OTCYesYes► Subscribe► Subscribe
Medtech Products
MONISTAT 3
miconazole nitrate
SUPPOSITORY;VAGINAL018888-001Aug 15, 1984ABRXYesYes► Subscribe► Subscribe
Insight Pharms
MONISTAT-DERM
miconazole nitrate
LOTION;TOPICAL017739-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Personal Prods
MONISTAT 5
miconazole nitrate
TAMPON;VAGINAL018592-001Oct 27, 1989DISCNNoNo► Subscribe► Subscribe
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Expired Patents for Tradename: MONISTAT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharma
MONISTAT
miconazole
INJECTABLE;INJECTION018040-001Approved Prior to Jan 1, 19823,717,655► Subscribe
Janssen Pharma
MONISTAT
miconazole
INJECTABLE;INJECTION018040-001Approved Prior to Jan 1, 19823,839,574► Subscribe
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Paragraph IV activity for: MONISTAT

Drugname Dosage Strength RLD Submissiondate
miconazole nitrateVaginal Cream and Suppository2% and 1.2 gMonistat 1 Combinati12/5/2007
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Serving 500+ biopharmaceutical companies globally:

Novartis
Dow
US Department of Justice
Merck
Fuji
Boehringer Ingelheim
Daiichi Sankyo
Baxter
Citi
Argus Health

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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