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Last Updated: April 18, 2021

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MICONAZOLE NITRATE Drug Profile

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When do Miconazole Nitrate patents expire, and when can generic versions of Miconazole Nitrate launch?

Miconazole Nitrate is a drug marketed by Perrigo R And D, Cosette, Perrigo, Taro Pharms, Teva, Teva Pharms, Actavis Pharma, and P And L. and is included in twelve NDAs.

The generic ingredient in MICONAZOLE NITRATE 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 Miconazole Nitrate

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

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Drug patent expirations by year for MICONAZOLE NITRATE
Drug Prices for MICONAZOLE NITRATE

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Drug Sales Revenue Trends for MICONAZOLE NITRATE

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Recent Clinical Trials for MICONAZOLE NITRATE

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SponsorPhase
Aesculape CRO Belgium BVPhase 2
Population CouncilPhase 1
Galeno Desenvolvimento de Pesquisas ClínicasPhase 2

See all MICONAZOLE NITRATE clinical trials

Pharmacology for MICONAZOLE NITRATE
Paragraph IV (Patent) Challenges for MICONAZOLE NITRATE
Tradename Dosage Ingredient NDA Submissiondate
MONISTAT 1 COMBINATION PACK CREAM, SUPPOSITORY;TOPICAL, VAGINAL miconazole nitrate 021308 2007-12-05

US Patents and Regulatory Information for MICONAZOLE NITRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo R And D MICONAZOLE NITRATE miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 079114-001 Jun 2, 2010 OTC No No   Start Trial   Start Trial   Start Trial
Teva Pharms MICONAZOLE NITRATE miconazole nitrate CREAM;VAGINAL 074030-001 Oct 30, 1992 DISCN No No   Start Trial   Start Trial   Start Trial
Perrigo R And D MICONAZOLE NITRATE miconazole nitrate CREAM;VAGINAL 091366-001 Jan 15, 2010 OTC No No   Start Trial   Start Trial   Start Trial
Perrigo MICONAZOLE NITRATE COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 075329-001 Apr 20, 1999 OTC No No   Start Trial   Start Trial   Start Trial
Actavis Pharma MICONAZOLE NITRATE miconazole nitrate SUPPOSITORY;VAGINAL 073508-001 Nov 19, 1993 AB RX No No   Start Trial   Start Trial   Start Trial
Cosette MICONAZOLE NITRATE miconazole nitrate CREAM;VAGINAL 074366-001 Feb 22, 1996 OTC No No   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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