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Generated: November 15, 2018

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Details for New Drug Application (NDA): 201023

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NDA 201023 describes JEVTANA KIT, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the JEVTANA KIT profile page.

The generic ingredient in JEVTANA KIT is cabazitaxel. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cabazitaxel profile page.
Summary for 201023
Tradename:JEVTANA KIT
Applicant:Sanofi Aventis Us
Ingredient:cabazitaxel
Patents:3
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 201023
Generic Entry Date for 201023*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;IV (INFUSION)

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 201023
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023 NDA Sanofi-Aventis U.S. LLC 0024-5824 0024-5824-11 1 KIT in 1 CARTON (0024-5824-11) * 5.7 mL in 1 VIAL, GLASS (0024-5823-15) * 5.7 mL in 1 VIAL, GLASS (0024-5822-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength60MG/1.5ML (40MG/ML)
Approval Date:Jun 17, 2010TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 14, 2020
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING REGARDING CABAZITAXEL AT 20 MG/M2 BASED ON THE RESULTS OF THE PROSELICA STUDY
Regulatory Exclusivity Expiration:Nov 17, 2020
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:May 17, 2020
Regulatory Exclusivity Use:REVISIONS TO THE PACKAGE INSERT BASED ON DATA FROM AN OPEN LABEL, MULTI-CENTER STUDY OF CABAZITAXEL IN PEDIATRIC PATIENTS WITH REFRACTORY SOLID TUMORS INCLUDING TUMORS OF THE CENTRAL NERVOUS SYSTEM.

Expired US Patents for NDA 201023

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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