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Last Updated: May 8, 2021

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Miconazole nitrate - Generic Drug Details

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

Miconazole nitrate is the generic ingredient in seventeen branded drugs marketed by P And L, Actavis Mid Atlantic, Cosette, Perrigo R And D, Perrigo, Medtech Products, Insight Pharms, Taro, Taro Pharms, 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 twenty-eight drug master file entries for miconazole nitrate. Forty-six 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
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
Personal Prods MONISTAT 5 miconazole nitrate TAMPON;VAGINAL 018592-001 Oct 27, 1989 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Teva Pharms MICONAZOLE NITRATE miconazole nitrate CREAM;VAGINAL 074030-001 Oct 30, 1992 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Medtech Products MONISTAT 1 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 021308-001 Jun 29, 2001 OTC Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Perrigo MICONAZOLE NITRATE miconazole nitrate CREAM;VAGINAL 074760-001 May 15, 1997 OTC No No   Get Started for $10   Get Started for $10   Get Started for $10
Insight Pharms MONISTAT-DERM miconazole nitrate CREAM;TOPICAL 017494-001 Approved Prior to Jan 1, 1982 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Medtech Products MONISTAT 3 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 020670-002 Apr 16, 1996 OTC Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
>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
Insight Pharms MONISTAT-DERM miconazole nitrate LOTION;TOPICAL 017739-001 Approved Prior to Jan 1, 1982   Get Started for $10   Get Started for $10
Insight Pharms MONISTAT-DERM miconazole nitrate CREAM;TOPICAL 017494-001 Approved Prior to Jan 1, 1982   Get Started for $10   Get Started for $10
Medtech Products MONISTAT 1 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 021308-001 Jun 29, 2001   Get Started for $10   Get Started for $10
Insight Pharms MONISTAT-DERM miconazole nitrate CREAM;TOPICAL 017494-001 Approved Prior to Jan 1, 1982   Get Started for $10   Get Started for $10
Insight Pharms MONISTAT-DERM miconazole nitrate LOTION;TOPICAL 017739-001 Approved Prior to Jan 1, 1982   Get Started for $10   Get Started for $10
Medtech Products MONISTAT 3 miconazole nitrate SUPPOSITORY;VAGINAL 018888-001 Aug 15, 1984   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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