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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.

Summary for miconazole nitrate

US Patents:	1
Tradenames:	17
Applicants:	14
NDAs:	30
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	46
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	6
Patent Applications:	2,912
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for miconazole nitrate
What excipients (inactive ingredients) are in miconazole nitrate?	miconazole nitrate excipients list
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
Aesculape CRO Belgium BV	Phase 2
Population Council	Phase 1
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
Personal Prods	MONISTAT 5	miconazole nitrate	TAMPON;VAGINAL	018592-001	Oct 27, 1989		DISCN	No	No
Teva Pharms	MICONAZOLE NITRATE	miconazole nitrate	CREAM;VAGINAL	074030-001	Oct 30, 1992		DISCN	No	No
Medtech Products	MONISTAT 1 COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	021308-001	Jun 29, 2001		OTC	Yes	Yes
Perrigo	MICONAZOLE NITRATE	miconazole nitrate	CREAM;VAGINAL	074760-001	May 15, 1997		OTC	No	No
Insight Pharms	MONISTAT-DERM	miconazole nitrate	CREAM;TOPICAL	017494-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Medtech Products	MONISTAT 3 COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	020670-002	Apr 16, 1996		OTC	Yes	Yes

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
Insight Pharms	MONISTAT-DERM	miconazole nitrate	CREAM;TOPICAL	017494-001	Approved Prior to Jan 1, 1982
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
Medtech Products	MONISTAT 3	miconazole nitrate	SUPPOSITORY;VAGINAL	018888-001	Aug 15, 1984