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JEVTANA KIT Drug Profile

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Jevtana Kit is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. There are six patents protecting this drug.

This drug has one hundred and eighty-seven patent family members in fifty-seven countries.

The generic ingredient in JEVTANA KIT is cabazitaxel. There are twelve drug master file entries for this compound. One supplier is listed for this compound. There are two tentative approvals for this compound. Additional details are available on the cabazitaxel profile page.

Summary for Tradename: JEVTANA KIT

Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Clinical Trials for: JEVTANA KIT

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
JEVTANA KIT
cabazitaxel
SOLUTION;IV (INFUSION)201023-001Jun 17, 2010RXYes6,372,780<disabled> <disabled>
Sanofi Aventis Us
JEVTANA KIT
cabazitaxel
SOLUTION;IV (INFUSION)201023-001Jun 17, 2010RXYes7,241,907<disabled>Y <disabled>
Sanofi Aventis Us
JEVTANA KIT
cabazitaxel
SOLUTION;IV (INFUSION)201023-001Jun 17, 2010RXYes6,387,946<disabled> <disabled>
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Expired Patents for Tradename: JEVTANA KIT

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
JEVTANA KIT
cabazitaxel
SOLUTION;IV (INFUSION)201023-001Jun 17, 20105,438,072<disabled>
Sanofi Aventis Us
JEVTANA KIT
cabazitaxel
SOLUTION;IV (INFUSION)201023-001Jun 17, 20106,372,780<disabled>
Sanofi Aventis Us
JEVTANA KIT
cabazitaxel
SOLUTION;IV (INFUSION)201023-001Jun 17, 20106,331,635<disabled>
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Non-Orange Book Patents for Tradename: JEVTANA KIT

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
5,889,043 Taxoids, preparation thereof and pharmaceutical Compositions containing same<disabled in preview>
6,232,477 Methods of preparing new taxoids and pharmaceutical compositions containing them<disabled in preview>
6,187,916 Process for the preparation of taxane derivatives and .beta.-lactam intermediates therefor<disabled in preview>
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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 Tradename: JEVTANA KIT

Country Document Number Estimated Expiration
Guatemala201200123<disabled in preview>
Hungary9801201<disabled in preview>
African Regional IP Organization (ARIPO)9701093<disabled in preview>
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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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Supplementary Protection Certificates for Tradename: JEVTANA KIT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013010Lithuania<disabled>PRODUCT NAME: CABAZITAXELUM; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
C0037France<disabled>PRODUCT NAME: CABAZITAXEL SOUS FORME ACETONATE (OU SOLVAT ACETONIQUE DU CABAZITAXEL); REGISTRATION NO/DATE: EU/1/11/676/001 20110322
90025-3Sweden<disabled>PRODUCT NAME: CABAZITAXEL ACETONSOLVAT; REG. NO/DATE: EU/1/11/676/001 20110317
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