BUTOCONAZOLE NITRATE - Generic Drug Details

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

Butoconazole nitrate is the generic ingredient in four branded drugs marketed by Padagis Us, Roche Palo, Bayer, and Padagis Israel, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for butoconazole nitrate. One supplier is listed for this compound.

Summary for BUTOCONAZOLE NITRATE

US Patents:	0
Tradenames:	4
Applicants:	4
NDAs:	5
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	4
Patent Applications:	1,435
What excipients (inactive ingredients) are in BUTOCONAZOLE NITRATE?	BUTOCONAZOLE NITRATE excipients list
DailyMed Link:	BUTOCONAZOLE NITRATE at DailyMed

Recent Clinical Trials for BUTOCONAZOLE NITRATE

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

Sponsor	Phase
EMS	Phase 2
Padagis LLC	N/A
Perrigo Company	N/A

See all BUTOCONAZOLE NITRATE clinical trials

Pharmacology for BUTOCONAZOLE NITRATE

Drug Class	Azole Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for BUTOCONAZOLE NITRATE

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

US Patents and Regulatory Information for BUTOCONAZOLE 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
Roche Palo	FEMSTAT	butoconazole nitrate	CREAM;VAGINAL	019215-001	Nov 25, 1985		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bayer	FEMSTAT 3	butoconazole nitrate	CREAM;VAGINAL	020421-001	Dec 21, 1995		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Israel	GYNAZOLE-1	butoconazole nitrate	CREAM;VAGINAL	200923-001	May 18, 2012		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Us	BUTOCONAZOLE NITRATE	butoconazole nitrate	CREAM;VAGINAL	019881-001	Feb 7, 1997		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Roche Palo	FEMSTAT	butoconazole nitrate	SUPPOSITORY;VAGINAL	019359-001	Nov 25, 1985		DISCN	No	No	⤷ 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 BUTOCONAZOLE NITRATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Padagis Us	BUTOCONAZOLE NITRATE	butoconazole nitrate	CREAM;VAGINAL	019881-001	Feb 7, 1997	⤷ Sign Up	⤷ Sign Up
Padagis Us	BUTOCONAZOLE NITRATE	butoconazole nitrate	CREAM;VAGINAL	019881-001	Feb 7, 1997	⤷ Sign Up	⤷ Sign Up
Roche Palo	FEMSTAT	butoconazole nitrate	CREAM;VAGINAL	019215-001	Nov 25, 1985	⤷ Sign Up	⤷ Sign Up
Roche Palo	FEMSTAT	butoconazole nitrate	SUPPOSITORY;VAGINAL	019359-001	Nov 25, 1985	⤷ Sign Up	⤷ Sign Up
Padagis Us	BUTOCONAZOLE NITRATE	butoconazole nitrate	CREAM;VAGINAL	019881-001	Feb 7, 1997	⤷ Sign Up	⤷ Sign Up
Bayer	FEMSTAT 3	butoconazole nitrate	CREAM;VAGINAL	020421-001	Dec 21, 1995	⤷ Sign Up	⤷ Sign Up
Padagis Us	BUTOCONAZOLE NITRATE	butoconazole nitrate	CREAM;VAGINAL	019881-001	Feb 7, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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