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Cabazitaxel - Generic Drug Details
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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 list | 12 |
| Suppliers / Packaging: see list | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
Tentative approvals for CABAZITAXEL
| Applicant | Application No. | Form | Dosage |
| <disabled> | <disabled> | INJECTABLE;INJECTION | 20MG/ML(60MG/3ML) |
| <disabled> | <disabled> | INJECTABLE;INJECTION | 40MG/4ML |
| <disabled> | <disabled> | INJECTABLE;INJECTION | 60MG/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) | 201023-001 | Jun 17, 2010 | RX | Yes | 6,387,946 | Mar 26, 2016 | ||||||||||||||||||||
Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;IV (INFUSION) | 201023-001 | Jun 17, 2010 | RX | Yes | 6,331,635 | Mar 26, 2016 | Y | Y | ||||||||||||||||||
Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;IV (INFUSION) | 201023-001 | Jun 17, 2010 | RX | Yes | 6,372,780 | Mar 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) | 201023-001 | Jun 17, 2010 | 5,438,072 | <disabled> | ||||||||||||||||||||||
Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;IV (INFUSION) | 201023-001 | Jun 17, 2010 | 5,698,582 | <disabled> | ||||||||||||||||||||||
Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;IV (INFUSION) | 201023-001 | Jun 17, 2010 | 6,387,946 | <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 Zealand | 545835 | <disabled in preview> | |||||||||||||||||||||||||||
| Peru | 51097 | <disabled in preview> | |||||||||||||||||||||||||||
| Japan | 3492367 | <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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 172 | Luxembourg | <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 00077 | Estonia | <disabled> | PRODUCT NAME: KABASITAKSEEL;REG NO/DATE: K(2011)1888 LOPLIK 17.03.2011 | ||||||||||||||||||||||||||
| 13/021 | Ireland | <disabled> | PRODUCT NAME: CABAZITAXEL ACETONE SOLVATE; REGISTRATION NO/DATE: EU/1/11/676/001 20110317 | ||||||||||||||||||||||||||
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