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Last Updated: August 8, 2020

DrugPatentWatch Database Preview

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 are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Miconazole nitrate has sixteen patent family members in thirteen countries.

There are twenty-eight 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
Population CouncilPhase 1
Biolab Sanus FarmaceuticaPhase 2
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
Medtech Products MONISTAT 3 COMBINATION PACK (PREFILLED) miconazole nitrate CREAM;TOPICAL, VAGINAL 021261-001 Feb 2, 2001 OTC Yes Yes   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
Perrigo MICONAZOLE 3 COMBINATION PACK miconazole nitrate CREAM;TOPICAL, VAGINAL 076357-001 Mar 30, 2004 OTC No No   Start Trial   Start Trial   Start Trial
Medtech Products MONISTAT 1 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 021308-001 Jun 29, 2001 OTC Yes Yes   Start Trial   Start Trial Y   Start Trial
P And L M-ZOLE 3 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 074926-001 Apr 16, 1999 OTC No No   Start Trial   Start Trial   Start Trial
Medtech Products MONISTAT 3 miconazole nitrate SUPPOSITORY;VAGINAL 018888-001 Aug 15, 1984 AB RX Yes Yes   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

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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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Harvard Business School

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