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Last Updated: May 14, 2021

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MONISTAT 3 Drug Profile

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When do Monistat 3 patents expire, and when can generic versions of Monistat 3 launch?

Monistat 3 is a drug marketed by Medtech Products and is included in four NDAs.

The generic ingredient in MONISTAT 3 is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Monistat 3

A generic version of MONISTAT 3 was approved as miconazole nitrate by ACTAVIS PHARMA on November 19th, 1993.

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Summary for MONISTAT 3
Drug patent expirations by year for MONISTAT 3
Drug Sales Revenue Trends for MONISTAT 3

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Recent Clinical Trials for MONISTAT 3

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SponsorPhase
Universidad Autonoma de San Luis PotosíPhase 4
Hospital Central "Dr. Ignacio Morones Prieto"Phase 4

See all MONISTAT 3 clinical trials

US Patents and Regulatory Information for MONISTAT 3

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medtech Products MONISTAT 3 miconazole nitrate CREAM;VAGINAL 020827-001 Mar 30, 1998 OTC Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Medtech Products MONISTAT 3 COMBINATION PACK miconazole nitrate CREAM;TOPICAL, VAGINAL 021261-003 Jun 17, 2003 OTC Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Medtech Products MONISTAT 3 miconazole nitrate SUPPOSITORY;VAGINAL 018888-001 Aug 15, 1984 AB RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for MONISTAT 3

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medtech Products MONISTAT 3 miconazole nitrate SUPPOSITORY;VAGINAL 018888-001 Aug 15, 1984   Get Started for $10   Get Started for $10
Medtech Products MONISTAT 3 miconazole nitrate SUPPOSITORY;VAGINAL 018888-001 Aug 15, 1984   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Dow
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Harvard Business School
Express Scripts
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Merck

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