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Butoconazole nitrate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for butoconazole nitrate?

Butoconazole nitrate is the generic ingredient in four branded drugs marketed by Roche Palo, Bayer, Perrigo Israel, and Perrigo Pharma Intl, and is included in five NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Butoconazole nitrate has thirteen patent family members in ten countries.

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

Summary for Generic Name: butoconazole nitrate

Tradenames:4
Patents:2
Applicants:4
NDAs:5
Drug Master File Entries: see list6
Suppliers / Packagers: see list1
Bulk Api Vendors: see list46
Clinical Trials: see list45
Patent Applications: see list739
Therapeutic Class:Antifungals
Drug Prices:see low prices
DailyMed Link:butoconazole nitrate at DailyMed

Pharmacology for Ingredient: butoconazole nitrate

Ingredient-typeAzoles
Drug ClassAzole Antifungal
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo Israel
GYNAZOLE-1
butoconazole nitrate
CREAM;VAGINAL200923-001May 18, 2012RXNoYes► Subscribe► Subscribe
Bayer
FEMSTAT 3
butoconazole nitrate
CREAM;VAGINAL020421-001Dec 21, 1995OTCYesYes► Subscribe► Subscribe
Perrigo Pharma Intl
BUTOCONAZOLE NITRATE
butoconazole nitrate
CREAM;VAGINAL019881-001Feb 7, 1997DISCNNoNo5,993,856► SubscribeY ► Subscribe
Roche Palo
FEMSTAT
butoconazole nitrate
SUPPOSITORY;VAGINAL019359-001Nov 25, 1985DISCNNoNo► Subscribe► Subscribe
Roche Palo
FEMSTAT
butoconazole nitrate
CREAM;VAGINAL019215-001Nov 25, 1985DISCNNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: butoconazole nitrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo
FEMSTAT
butoconazole nitrate
CREAM;VAGINAL019215-001Nov 25, 19854,078,071► Subscribe
Perrigo Pharma Intl
BUTOCONAZOLE NITRATE
butoconazole nitrate
CREAM;VAGINAL019881-001Feb 7, 19975,266,329► Subscribe
Bayer
FEMSTAT 3
butoconazole nitrate
CREAM;VAGINAL020421-001Dec 21, 19954,078,071► Subscribe
Perrigo Pharma Intl
BUTOCONAZOLE NITRATE
butoconazole nitrate
CREAM;VAGINAL019881-001Feb 7, 19974,551,148► Subscribe
Perrigo Pharma Intl
BUTOCONAZOLE NITRATE
butoconazole nitrate
CREAM;VAGINAL019881-001Feb 7, 19974,078,071► Subscribe
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Non-Orange Book Patents for Generic Ingredient: butoconazole nitrate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,416,778 Pharmaceutical preparations and methods for their regional administration► Subscribe
6,652,874 Pharmaceutical preparations and methods for their regional administration► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: butoconazole nitrate

Country Document Number Estimated Expiration
Germany69834025► Subscribe
Australia743157► Subscribe
Australia5922798► Subscribe
Denmark0977555► Subscribe
Canada2278541► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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