Miconazole nitrate - Generic Drug Details

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 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 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. Forty-eight suppliers are listed for this compound.

Summary for miconazole nitrate

US Patents:	1
Tradenames:	17
Applicants:	15
NDAs:	30
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	48
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	7
Patent Applications:	5,387
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
Biolab Sanus Farmaceutica	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

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 1 COMBINATION PACK	miconazole nitrate	CREAM, INSERT;TOPICAL, VAGINAL	021308-001	Jun 29, 2001		OTC	Yes	Yes
Medtech Products	MONISTAT 3 COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	020670-002	Apr 16, 1996		OTC	Yes	Yes
Medtech Products	MONISTAT 3 COMBINATION PACK	miconazole nitrate	CREAM;TOPICAL, VAGINAL	021261-003	Jun 17, 2003		OTC	Yes	No
Medtech Products	MONISTAT 3 COMBINATION PACK (PREFILLED)	miconazole nitrate	CREAM;TOPICAL, VAGINAL	021261-001	Feb 2, 2001		OTC	Yes	Yes
Medtech Products	MONISTAT 7	miconazole nitrate	SUPPOSITORY;VAGINAL	018520-002	Feb 15, 1991		OTC	Yes	Yes

Expired US Patents for miconazole nitrate

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