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Serving leading biopharmaceutical companies globally:

Deloitte
Medtronic
Julphar
US Army
Fish and Richardson
Argus Health
US Department of Justice
Dow
Merck
Queensland Health

Generated: December 11, 2017

DrugPatentWatch Database Preview

MONISTAT Drug Profile

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When do Monistat patents expire, 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.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Janssen PharmaMONISTATmiconazoleINJECTABLE;INJECTION018040-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Medtech ProductsMONISTAT 3 COMBINATION PACK (PREFILLED)miconazole nitrateCREAM;TOPICAL, VAGINAL021261-001Feb 2, 2001OTCYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Medtech ProductsMONISTAT 3miconazole nitrateSUPPOSITORY;VAGINAL018888-001Aug 15, 1984ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Insight PharmsMONISTAT-DERMmiconazole nitrateCREAM;TOPICAL017494-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Personal ProdsMONISTAT 5miconazole nitrateTAMPON;VAGINAL018592-001Oct 27, 1989DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Medtech ProductsMONISTAT 1 COMBINATION PACKmiconazole nitrateCREAM, SUPPOSITORY;TOPICAL, VAGINAL021308-001Jun 29, 2001OTCYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Medtech ProductsMONISTAT 3miconazole nitrateCREAM;VAGINAL020827-001Mar 30, 1998OTCYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Medtech ProductsMONISTAT 3 COMBINATION PACKmiconazole nitrateCREAM;TOPICAL, VAGINAL021261-003Jun 17, 2003OTCYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Medtech ProductsMONISTAT 3 COMBINATION PACKmiconazole nitrateCREAM, SUPPOSITORY;TOPICAL, VAGINAL020670-002Apr 16, 1996OTCYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Medtech ProductsMONISTAT 7miconazole nitrateSUPPOSITORY;VAGINAL018520-002Feb 15, 1991OTCYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: MONISTAT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen PharmaMONISTATmiconazoleINJECTABLE;INJECTION018040-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Janssen PharmaMONISTATmiconazoleINJECTABLE;INJECTION018040-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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 leading biopharmaceutical companies globally:

McKinsey
Baxter
US Army
Federal Trade Commission
Merck
Healthtrust
Fish and Richardson
Fuji
Cipla
Mallinckrodt

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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