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Cabazitaxel - Generic Drug Details

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Cabazitaxel is the generic ingredient in one branded drug marketed by Sanofi Aventis Us and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are twelve drug master file entries for cabazitaxel. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: cabazitaxel

Tradenames:1
Patents:6
Applicants:1
NDAs:1
Drug Master File Entries: see list12
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details

Tentative approvals for CABAZITAXEL

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE;INJECTION20MG/ML(60MG/3ML)
<disabled><disabled>INJECTABLE;INJECTION40MG/4ML
<disabled><disabled>INJECTABLE;INJECTION60MG/6ML

Clinical Trials for: cabazitaxel

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, 2010RXYes5,847,170<disabled>YY <disabled>
Sanofi Aventis Us
JEVTANA KIT
cabazitaxel
SOLUTION;IV (INFUSION)201023-001Jun 17, 2010RXYes6,387,946<disabled> <disabled>
Sanofi Aventis Us
JEVTANA KIT
cabazitaxel
SOLUTION;IV (INFUSION)201023-001Jun 17, 2010RXYes7,241,907<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: cabazitaxel

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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 Generic Ingredient: cabazitaxel

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
6,593,482 Methods for preparing new taxoids and pharmaceutical compositions containing them<disabled in preview>
6,040,466 Taxoids, their preparation and pharmaceutical compositions containing them<disabled in preview>
6,218,553 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 Ingredient: cabazitaxel

Country Document Number Estimated Expiration
Australia2015200149<disabled in preview>
Estonia03608<disabled in preview>
Canada2779009<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: CABAZITAXEL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
13/021Ireland<disabled>PRODUCT NAME: CABAZITAXEL ACETONE SOLVATE; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
00595Netherlands<disabled>PRODUCT NAME: CABAZITAXEL ACETONAAT; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
90025-3Sweden<disabled>PRODUCT NAME: CABAZITAXEL ACETONSOLVAT; REG. NO/DATE: EU/1/11/676/001 20110317
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