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Last Updated: March 29, 2024

MICONAZOLE - Generic Drug Details


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What are the generic drug sources for miconazole and what is the scope of freedom to operate?

Miconazole is the generic ingredient in nineteen branded drugs marketed by Janssen Pharma, Galt Pharms, Perrigo R And D, Medtech Products, P And L, Actavis Mid Atlantic, Cosette, L Perrigo Co, Insight Pharms, Perrigo, Taro, Teva, Teva Pharms, Actavis Pharma, Personal Prods, and Mylan, and is included in thirty-two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-eight drug master file entries for miconazole. One supplier is listed for this compound.

Drug Prices for MICONAZOLE

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Drug Sales Revenue Trends for MICONAZOLE

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Recent Clinical Trials for MICONAZOLE

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

SponsorPhase
Hill Dermaceuticals, Inc.Phase 3
Aesculape CRO Belgium BVPhase 2
Abond CRO Inc.Phase 2/Phase 3

See all MICONAZOLE clinical trials

Pharmacology for MICONAZOLE
Drug ClassAzole Antifungal

US Patents and Regulatory Information for MICONAZOLE

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 COMBINATION PACK (PREFILLED) miconazole nitrate CREAM;TOPICAL, VAGINAL 021261-001 Feb 2, 2001 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan VUSION miconazole nitrate; white petrolatum; zinc oxide OINTMENT;TOPICAL 021026-001 Feb 16, 2006 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Perrigo R And D MICONAZOLE NITRATE miconazole nitrate CREAM;VAGINAL 091366-001 Jan 15, 2010 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cosette MICONAZOLE NITRATE miconazole nitrate SUPPOSITORY;VAGINAL 074414-001 Apr 30, 1997 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Insight Pharms MONISTAT-DERM miconazole nitrate CREAM;TOPICAL 017494-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Medtech Products MONISTAT 3 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 020670-002 Apr 16, 1996 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 MICONAZOLE

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 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharma MONISTAT miconazole INJECTABLE;INJECTION 018040-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Galt Pharms ORAVIG miconazole TABLET;BUCCAL 022404-001 Apr 16, 2010 ⤷  Try a Trial ⤷  Try a Trial
Galt Pharms ORAVIG miconazole TABLET;BUCCAL 022404-001 Apr 16, 2010 ⤷  Try a Trial ⤷  Try a Trial
Galt Pharms ORAVIG miconazole TABLET;BUCCAL 022404-001 Apr 16, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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