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Last Updated: August 8, 2020

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MONISTAT 7 Drug Profile

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Which patents cover Monistat 7, and when can generic versions of Monistat 7 launch?

Monistat 7 is a drug marketed by Medtech Products and is included in three NDAs.

The generic ingredient in MONISTAT 7 is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.

US ANDA Litigation and Generic Entry Outlook for Monistat 7

A generic version of MONISTAT 7 was approved as miconazole nitrate by ACTAVIS PHARMA on November 19th, 1993.

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Drug patent expirations by year for MONISTAT 7
Recent Clinical Trials for MONISTAT 7

Identify potential brand extensions & 505(b)(2) entrants

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

See all MONISTAT 7 clinical trials

US Patents and Regulatory Information for MONISTAT 7

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 7 miconazole nitrate CREAM;VAGINAL 017450-002 Feb 15, 1991 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Medtech Products MONISTAT 7 miconazole nitrate SUPPOSITORY;VAGINAL 018520-002 Feb 15, 1991 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Medtech Products MONISTAT 7 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 020288-002 Apr 26, 1993 OTC Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Express Scripts
Dow
Johnson and Johnson
Colorcon
Merck

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