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Last Updated: November 21, 2024

MONISTAT 3 Drug Patent 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. Fifty-one 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
US Patents:0
Applicants:1
NDAs:4
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 238
Clinical Trials: 1
Patent Applications: 2,906
What excipients (inactive ingredients) are in MONISTAT 3?MONISTAT 3 excipients list
DailyMed Link:MONISTAT 3 at DailyMed
Drug patent expirations by year for MONISTAT 3
Drug Sales Revenue Trends for MONISTAT 3

See drug sales revenues for MONISTAT 3

Recent Clinical Trials for MONISTAT 3

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

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

See all MONISTAT 3 clinical trials

Pharmacology for MONISTAT 3
Drug ClassAzole Antifungal

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Medtech Products MONISTAT 3 COMBINATION PACK miconazole nitrate CREAM;TOPICAL, VAGINAL 021261-003 Jun 17, 2003 OTC Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Medtech Products MONISTAT 3 miconazole nitrate SUPPOSITORY;VAGINAL 018888-001 Aug 15, 1984 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Medtech Products MONISTAT 3 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 020670-002 Apr 16, 1996 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Medtech Products MONISTAT 3 miconazole nitrate SUPPOSITORY;VAGINAL 018888-001 Aug 15, 1984 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for MONISTAT 3

See the table below for patents covering MONISTAT 3 around the world.

Country Patent Number Title Estimated Expiration
Czechoslovakia 184753 FUNGICIDAL AND BACTERICIDAL AGENT ⤷  Sign Up
Israel 32840 1-(BETA-ARYL-ETHYL)-IMIDAZOLE ETHERS AND AMINES ⤷  Sign Up
Netherlands 6912331 ⤷  Sign Up
Switzerland 532585 Procédé de fabrication de dérivés d'imidazole (Imidazole derivs antifungals and antibacterials) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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