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Last Updated: January 25, 2022

DrugPatentWatch Database Preview

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 five 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:5
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 201023
Generic Entry Date for 201023*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS

*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)
Paragraph IV (Patent) Challenges for 201023
Tradename Dosage Ingredient NDA Submissiondate
JEVTANA KIT SOLUTION;INTRAVENOUS cabazitaxel 201023 2014-06-17

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:Dec 18, 2023
Regulatory Exclusivity Use:CLINICAL TRIAL STUDY RESULTS
Patent:⤷  Try it FreePatent Expiration:Oct 27, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:INCREASING SURVIVAL IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER PATIENTS PREVIOUSLY TREATED WITH DOCETAXEL BY ADMINISTERING AS A 3 WEEK CYCLE CABAZITAXEL AFTER 5 MG DEXCHLORPHENIRAMINE, 8 MG DEXAMETHASONE, AND AN H2-AGONIST
Patent:⤷  Try it FreePatent Expiration:Oct 27, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:INCREASING SURVIVAL IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER PATIENTS PREVIOUSLY TREATED WITH DOCETAXEL BY ADMINISTERING 20 TO 25 MG/M2 CABAZITAXEL AFTER A PREMEDICATION REGIMEN THAT INCLUDES AN H2-ANTAGONIST

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

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