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Last Updated: September 29, 2020

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BUTOCONAZOLE NITRATE Drug Profile

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When do Butoconazole Nitrate patents expire, and what generic alternatives are available?

Butoconazole Nitrate is a drug marketed by Perrigo Pharma Intl and is included in one NDA.

The generic ingredient in BUTOCONAZOLE NITRATE is butoconazole nitrate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the butoconazole nitrate profile page.

Summary for BUTOCONAZOLE NITRATE
Drug patent expirations by year for BUTOCONAZOLE NITRATE
Recent Clinical Trials for BUTOCONAZOLE NITRATE

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SponsorPhase
Perrigo CompanyN/A

See all BUTOCONAZOLE NITRATE clinical trials

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
>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
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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