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Last Updated: September 29, 2020

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Butoconazole nitrate - Generic Drug Details

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

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

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

Summary for butoconazole nitrate
Recent Clinical Trials for butoconazole nitrate

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

SponsorPhase
Perrigo CompanyN/A

See all butoconazole nitrate clinical trials

Pharmacology for butoconazole nitrate
Paragraph IV (Patent) Challenges for BUTOCONAZOLE NITRATE
Tradename Dosage Ingredient NDA Submissiondate
BUTOCONAZOLE NITRATE CREAM;VAGINAL butoconazole nitrate 019881 2009-12-23
GYNAZOLE-1 CREAM;VAGINAL butoconazole nitrate 200923 2009-12-23

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
Perrigo Pharma Intl BUTOCONAZOLE NITRATE butoconazole nitrate CREAM;VAGINAL 019881-001 Feb 7, 1997 DISCN No No   Start Trial   Start Trial   Start Trial
Roche Palo FEMSTAT butoconazole nitrate SUPPOSITORY;VAGINAL 019359-001 Nov 25, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Bayer FEMSTAT 3 butoconazole nitrate CREAM;VAGINAL 020421-001 Dec 21, 1995 DISCN Yes No   Start Trial   Start Trial   Start Trial
Roche Palo FEMSTAT butoconazole nitrate CREAM;VAGINAL 019215-001 Nov 25, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Perrigo Israel GYNAZOLE-1 butoconazole nitrate CREAM;VAGINAL 200923-001 May 18, 2012 RX No Yes   Start Trial   Start Trial   Start 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
Roche Palo FEMSTAT butoconazole nitrate CREAM;VAGINAL 019215-001 Nov 25, 1985   Start Trial   Start Trial
Perrigo Pharma Intl BUTOCONAZOLE NITRATE butoconazole nitrate CREAM;VAGINAL 019881-001 Feb 7, 1997   Start Trial   Start Trial
Perrigo Pharma Intl BUTOCONAZOLE NITRATE butoconazole nitrate CREAM;VAGINAL 019881-001 Feb 7, 1997   Start Trial   Start Trial
Perrigo Pharma Intl BUTOCONAZOLE NITRATE butoconazole nitrate CREAM;VAGINAL 019881-001 Feb 7, 1997   Start Trial   Start Trial
Perrigo Pharma Intl BUTOCONAZOLE NITRATE butoconazole nitrate CREAM;VAGINAL 019881-001 Feb 7, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
Colorcon
McKinsey
Johnson and Johnson
Express Scripts

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