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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 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.

Summary for miconazole nitrate

International Patents:	16
US Patents:	2
Tradenames:	17
Applicants:	14
NDAs:	30
Drug Master File Entries:	28
Suppliers / Packagers:	47
Bulk Api Vendors:	88
Clinical Trials:	5
Patent Applications:	2,775
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for miconazole nitrate
DailyMed Link:	miconazole nitrate at DailyMed

See drug prices for miconazole nitrate

See drug sales revenues for miconazole nitrate

Recent Clinical Trials for miconazole nitrate

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

Sponsor	Phase
Population Council	Phase 1
Biolab Sanus Farmaceutica	Phase 2
Galeno Desenvolvimento de Pesquisas Clínicas	Phase 2

See all miconazole nitrate clinical trials

Pharmacology for miconazole nitrate

Drug Class

Azole Antifungal

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
Cosette	MICONAZOLE NITRATE	miconazole nitrate	CREAM;VAGINAL	074366-001	Feb 22, 1996		OTC	No	No
Perrigo	MICONAZOLE 3 COMBINATION PACK	miconazole nitrate	CREAM;TOPICAL, VAGINAL	076357-001	Mar 30, 2004		OTC	No	No
Medtech Products	MONISTAT 1 COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	021308-001	Jun 29, 2001		OTC	Yes	Yes					Y
P And L	M-ZOLE 3 COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	074926-001	Apr 16, 1999		OTC	No	No
Medtech Products	MONISTAT 3	miconazole nitrate	SUPPOSITORY;VAGINAL	018888-001	Aug 15, 1984	AB	RX	Yes	Yes

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
Medtech Products	MONISTAT 1 COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	021308-001	Jun 29, 2001
Insight Pharms	MONISTAT-DERM	miconazole nitrate	CREAM;TOPICAL	017494-001	Approved Prior to Jan 1, 1982
Insight Pharms	MONISTAT-DERM	miconazole nitrate	LOTION;TOPICAL	017739-001	Approved Prior to Jan 1, 1982
Insight Pharms	MONISTAT-DERM	miconazole nitrate	LOTION;TOPICAL	017739-001	Approved Prior to Jan 1, 1982
Medtech Products	MONISTAT 3	miconazole nitrate	SUPPOSITORY;VAGINAL	018888-001	Aug 15, 1984

International Patents for miconazole nitrate

Country	Patent Number	Estimated Expiration
Japan	2002530327
Argentina	021863
European Patent Office	1051162
Brazil	9907150
Spain	2262353
Australia	777508