Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Additional Information about Patents

  • Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
  • Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
  • As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.

Patent and Exclusivity for: N201023

Product 001
CABAZITAXEL (JEVTANA KIT) SOLUTION 60MG/1.5ML (40MG/ML)

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 5847170 03/26/2021 DS DP
001 5847170*PED 09/26/2021
001 7241907 12/10/2025 DS
001 7241907*PED 06/10/2026
001 8927592 10/27/2030
U-1630 TREATMENT IN COMBINATION WITH A CORTICOID SUCH AS PREDNISONE OF PROSTATE CANCER PREVIOUSLY TREATED WITH DOCETAXEL
01/12/2015
001 8927592*PED 04/27/2031
001 10583110 10/27/2030
U-2753 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
03/17/2020
001 10716777 10/27/2030
U-2856 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
07/21/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
M-201REVISIONS 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.
COMPETITIVE GENERIC THERAPY
05/17/2020
001
M-209INFORMATION ADDED TO THE LABELING REGARDING CABAZITAXEL AT 20 MG/M2 BASED ON THE RESULTS OF THE PROSELICA STUDY
COMPETITIVE GENERIC THERAPY
09/14/2020
001
M-201REVISIONS 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.
*PED PEDIATRIC EXCLUSIVITY
11/17/2020

 

 


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