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Miconazole - Generic Drug Details

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

Miconazole is the generic ingredient in nineteen branded drugs marketed by Janssen Pharma, Galt Pharms, 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-two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Miconazole has twenty-four patent family members in fourteen countries.

There are twenty-eight drug master file entries for miconazole.

Summary for miconazole

International Patents:	24
US Patents:	4
Tradenames:	19
Applicants:	16
NDAs:	32
Drug Master File Entries:	28
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	27
Patent Applications:	6,805
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for miconazole
What excipients (inactive ingredients) are in miconazole?	miconazole excipients list
DailyMed Link:	miconazole at DailyMed

See drug prices for miconazole

See drug sales revenues for miconazole

Recent Clinical Trials for miconazole

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

Sponsor	Phase
Aesculape CRO Belgium BV	Phase 2
Hill Dermaceuticals, Inc.	Phase 2/Phase 3
Abond CRO Inc.	Phase 2/Phase 3

See all miconazole clinical trials

Medical Subject Heading (MeSH) Categories for miconazole

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP2C9 Inhibitors

Cytochrome P-450 CYP3A Inhibitors

US Patents and Regulatory Information for miconazole

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 7	miconazole nitrate	CREAM;VAGINAL	017450-002	Feb 15, 1991		OTC	Yes	Yes
P And L	MICONAZOLE NITRATE	miconazole nitrate	SUPPOSITORY;VAGINAL	073507-001	Nov 19, 1993		OTC	No	No
Cosette	MICONAZOLE 7 COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	076585-001	Mar 26, 2004		DISCN	No	No
Perrigo	MICONAZOLE NITRATE	miconazole nitrate	CREAM;VAGINAL	074760-001	May 15, 1997		OTC	No	No
P And L	M-ZOLE 3 COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	074926-001	Apr 16, 1999		OTC	No	No

Expired US Patents for miconazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharma	MONISTAT	miconazole	INJECTABLE;INJECTION	018040-001	Approved Prior to Jan 1, 1982
Janssen Pharma	MONISTAT	miconazole	INJECTABLE;INJECTION	018040-001	Approved Prior to Jan 1, 1982

International Patents for miconazole

Country	Patent Number	Estimated Expiration
Portugal	1408911
Spain	2294170
China	101524337
France	2827517
Austria	411003