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Last Updated: March 19, 2024

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: 1,551
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

SponsorPhase
EMSPhase 2
Perrigo CompanyN/A
Padagis LLCN/A

See all BUTOCONAZOLE NITRATE clinical trials

Pharmacology for BUTOCONAZOLE NITRATE
Drug ClassAzole Antifungal

US Patents and Regulatory Information for BUTOCONAZOLE NITRATE

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Padagis Us BUTOCONAZOLE NITRATE butoconazole nitrate CREAM;VAGINAL 019881-001 Feb 7, 1997 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roche Palo FEMSTAT butoconazole nitrate SUPPOSITORY;VAGINAL 019359-001 Nov 25, 1985 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

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 ⤷  Try a Trial ⤷  Try a Trial
Roche Palo FEMSTAT butoconazole nitrate CREAM;VAGINAL 019215-001 Nov 25, 1985 ⤷  Try a Trial ⤷  Try a Trial
Bayer FEMSTAT 3 butoconazole nitrate CREAM;VAGINAL 020421-001 Dec 21, 1995 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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