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, 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-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. One supplier is listed for this compound.

Summary for miconazole

International Patents:	24
US Patents:	4
Tradenames:	19
Applicants:	17
NDAs:	32
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	27
Patent Applications:	7,061
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

Drug Sales Revenue Trends for miconazole

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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

Pharmacology for miconazole

Drug Class	Azole Antifungal

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

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Glossary

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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	SUPPOSITORY;VAGINAL	018520-002	Feb 15, 1991		OTC	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Taro Pharms	MICONAZOLE NITRATE	miconazole nitrate	CREAM;VAGINAL	074444-001	Jan 13, 1997		OTC	No	No	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
Mylan	VUSION	miconazole nitrate; petrolatum, white; zinc oxide	OINTMENT;TOPICAL	021026-001	Feb 16, 2006		RX	Yes	Yes	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

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

International Patents for miconazole

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Country	Patent Number	Title	Estimated Expiration
France	2827517	SYSTEMES THERAPEUTIQUES BIOADHESIFS A LIBERATION PROLONGEE	See Plans and Pricing
Japan	2004537558		See Plans and Pricing
European Patent Office	1408911	SYSTEMES THERAPEUTIQUES BIOADHESIFS A LIBERATION PROLONGEE (SUSTAINED-RELEASE THERAPEUTIC BIOADHESIVE SYSTEMS)	See Plans and Pricing
China	101524337		See Plans and Pricing
Spain	2316108		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.