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Last Updated: June 26, 2022

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, 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 seventeen drug master file entries for miconazole nitrate. Forty-five 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

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

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Pharmacology for MICONAZOLE NITRATE

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
Cosette MICONAZOLE NITRATE miconazole nitrate SUPPOSITORY;VAGINAL 074414-001 Apr 30, 1997 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Medtech Products MONISTAT 7 miconazole nitrate SUPPOSITORY;VAGINAL 018520-002 Feb 15, 1991 OTC Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Insight Pharms MONISTAT-DERM miconazole nitrate LOTION;TOPICAL 017739-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Medtech Products MONISTAT 3 COMBINATION PACK miconazole nitrate CREAM;TOPICAL, VAGINAL 021261-003 Jun 17, 2003 OTC Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 CREAM;TOPICAL 017494-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Insight Pharms MONISTAT-DERM miconazole nitrate LOTION;TOPICAL 017739-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Medtech Products MONISTAT 3 miconazole nitrate SUPPOSITORY;VAGINAL 018888-001 Aug 15, 1984 See Plans and Pricing See Plans and Pricing
Medtech Products MONISTAT 1 COMBINATION PACK miconazole nitrate CREAM, INSERT;TOPICAL, VAGINAL 021308-001 Jun 29, 2001 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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McKinsey
Harvard Business School
Johnson and Johnson
Dow
Express Scripts

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