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Last Updated: March 18, 2024

Miconazole nitrate - Generic Drug Details


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What are the generic sources for miconazole nitrate and what is the scope of patent protection?

Miconazole nitrate is the generic ingredient in seventeen branded drugs marketed by 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 NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for miconazole nitrate. Forty-seven suppliers are listed for this compound.

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

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

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
Drug ClassAzole Antifungal

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;VAGINAL 091366-001 Jan 15, 2010 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Medtech Products MONISTAT 7 miconazole nitrate CREAM;VAGINAL 017450-002 Feb 15, 1991 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Medtech Products MONISTAT 3 COMBINATION PACK miconazole nitrate CREAM;TOPICAL, VAGINAL 021261-003 Jun 17, 2003 OTC Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro MICONAZOLE 3 miconazole nitrate CREAM;VAGINAL 076773-001 Mar 2, 2005 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Mid Atlantic M-ZOLE 7 DUAL PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 074586-001 Jul 17, 1997 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cosette MICONAZOLE NITRATE miconazole nitrate CREAM;VAGINAL 074366-001 Feb 22, 1996 OTC No No ⤷  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 nitrate

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 ⤷  Try a Trial ⤷  Try a Trial
Medtech Products MONISTAT 1 COMBINATION PACK miconazole nitrate CREAM, INSERT;TOPICAL, VAGINAL 021308-001 Jun 29, 2001 ⤷  Try a Trial ⤷  Try a Trial
Insight Pharms MONISTAT-DERM miconazole nitrate LOTION;TOPICAL 017739-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Insight Pharms MONISTAT-DERM miconazole nitrate LOTION;TOPICAL 017739-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Medtech Products MONISTAT 3 miconazole nitrate SUPPOSITORY;VAGINAL 018888-001 Aug 15, 1984 ⤷  Try a Trial ⤷  Try a Trial
Insight Pharms MONISTAT-DERM miconazole nitrate CREAM;TOPICAL 017494-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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