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Last Updated: April 12, 2021

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MONISTAT Drug Profile

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Which patents cover 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. 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

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

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

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 clinical trials

US Patents and Regulatory Information for MONISTAT

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;INJECTION 018040-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Medtech Products MONISTAT 3 COMBINATION PACK (PREFILLED) miconazole nitrate CREAM;TOPICAL, VAGINAL 021261-001 Feb 2, 2001 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Medtech Products MONISTAT 3 miconazole nitrate SUPPOSITORY;VAGINAL 018888-001 Aug 15, 1984 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Insight Pharms MONISTAT-DERM miconazole nitrate CREAM;TOPICAL 017494-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Personal Prods MONISTAT 5 miconazole nitrate TAMPON;VAGINAL 018592-001 Oct 27, 1989 DISCN No No   Start Trial   Start Trial   Start Trial
Medtech Products MONISTAT 1 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 021308-001 Jun 29, 2001 OTC Yes Yes   Start Trial   Start Trial Y   Start Trial
Medtech Products MONISTAT 3 miconazole nitrate CREAM;VAGINAL 020827-001 Mar 30, 1998 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

Expired US Patents for MONISTAT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharma MONISTAT miconazole INJECTABLE;INJECTION 018040-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Janssen Pharma MONISTAT miconazole INJECTABLE;INJECTION 018040-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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