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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
Drug Prices:see low prices

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, 2010RXYes6,387,946Mar 26, 2016
Sanofi Aventis Us
JEVTANA KIT
cabazitaxel
SOLUTION;IV (INFUSION)201023-001Jun 17, 2010RXYes6,331,635Mar 26, 2016YY
Sanofi Aventis Us
JEVTANA KIT
cabazitaxel
SOLUTION;IV (INFUSION)201023-001Jun 17, 2010RXYes6,372,780Mar 26, 2016
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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, 20105,698,582<disabled>
Sanofi Aventis Us
JEVTANA KIT
cabazitaxel
SOLUTION;IV (INFUSION)201023-001Jun 17, 20106,387,946<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>
6,187,916 Process for the preparation of taxane derivatives and .beta.-lactam intermediates therefor<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
New Zealand545835<disabled in preview>
Peru51097<disabled in preview>
Japan3492367<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
172Luxembourg<disabled>PRODUCT NAME: SOLVAT ACETONIQUE DU CABAZITAXEL, OU DESIGNE SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL OU SOLVAT ACETONIQUE DU (2R,3S)-3-TERT-BUTOXYCARBONYLAMINO-2-HYDROXY-3-PHENYLPROPIONATE DE 4-ACETOXY-2A-BENZOYLOXY-5BETA,20-EPOXY-1-HYDROXY-7BETA,10A-DIMETHOXY-9-OXO-TAX-11-ENE-13A-YLE(ACETONATE DU CABAZITAXEL)
0130017 00077Estonia<disabled>PRODUCT NAME: KABASITAKSEEL;REG NO/DATE: K(2011)1888 LOPLIK 17.03.2011
13/021Ireland<disabled>PRODUCT NAME: CABAZITAXEL ACETONE SOLVATE; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
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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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