MICONAZOLE NITRATE - Generic Drug Details

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

Miconazole nitrate is the generic ingredient in seventeen branded drugs marketed by Perrigo R And D, Medtech Products, Cosette, Actavis Mid Atlantic, L Perrigo Co, Insight Pharms, Perrigo, Taro, P And L, 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 seventeen drug master file entries for miconazole nitrate. Fifty-one suppliers are listed for this compound.

Summary for MICONAZOLE NITRATE

US Patents:	1
Tradenames:	17
Applicants:	14
NDAs:	30
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	51
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	7
Patent Applications:	5,050
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

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Drug Sales Revenue Trends for MICONAZOLE NITRATE

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Recent Clinical Trials for MICONAZOLE NITRATE

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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

Anatomical Therapeutic Chemical (ATC) Classes for MICONAZOLE NITRATE

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A07AC	Imidazole derivatives
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

D01AC	Imidazole and triazole derivatives
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

G01AF	Imidazole derivatives
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J02AB	Imidazole derivatives
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for MICONAZOLE NITRATE

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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
Perrigo	MICONAZOLE 3 COMBINATION PACK	miconazole nitrate	CREAM;TOPICAL, VAGINAL	076357-001	Mar 30, 2004		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Insight Pharms	MONISTAT-DERM	miconazole nitrate	CREAM;TOPICAL	017494-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
L Perrigo Co	MICONAZOLE NITRATE COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	075329-001	Apr 20, 1999		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Medtech Products	MONISTAT 7 COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	020288-002	Apr 26, 1993		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Medtech Products	MONISTAT 1 COMBINATION PACK	miconazole nitrate	CREAM, INSERT;TOPICAL, VAGINAL	021308-001	Jun 29, 2001		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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

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