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Last Updated: November 4, 2024

MONISTAT Drug Patent Profile


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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
Universidad Autonoma de San Luis PotosíPhase 4
Hospital Central "Dr. Ignacio Morones Prieto"Phase 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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Medtech Products MONISTAT 3 COMBINATION PACK (PREFILLED) miconazole nitrate CREAM;TOPICAL, VAGINAL 021261-001 Feb 2, 2001 OTC Yes Yes ⤷  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
Insight Pharms MONISTAT-DERM miconazole nitrate CREAM;TOPICAL 017494-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Personal Prods MONISTAT 5 miconazole nitrate TAMPON;VAGINAL 018592-001 Oct 27, 1989 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Medtech Products MONISTAT 1 COMBINATION PACK miconazole nitrate CREAM, INSERT;TOPICAL, VAGINAL 021308-001 Jun 29, 2001 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

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

International Patents for MONISTAT

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

Country Patent Number Title Estimated Expiration
Romania 56625 ⤷  Sign Up
Japan S51115 ⤷  Sign Up
U.S.S.R. 557755 ⤷  Sign Up
Czechoslovakia 194656 FUNGICIDE AND BACTERICIDE FOR PLANTS TREATMENT AND METHOD OF MAKING THE SAME ⤷  Sign Up
Netherlands 7100072 ⤷  Sign Up
Germany 1940388 1-(BETA-ARYL) AETHYLIMIDAZOLDERIVATE, IHRE HERSTELLUNG UND DIESE ENTHALTENDE FUNGIZIDE UND BAKTERIZIDE MITTEL ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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