Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Product Details

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: N021660

Product 001
PACLITAXEL (ABRAXANE) FOR SUSPENSION 100MG/VIAL

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7758891 02/21/2026
U-1434 TREATMENT OF PANCREATIC CANCER
10/02/2013
001 7758891*PED 08/21/2026
001 7820788 10/27/2024 DP
U-1092 TREATMENT OF BREAST CANCER
U-1290 TREATMENT OF LUNG CANCER
U-1434 TREATMENT OF PANCREATIC CANCER
11/12/2010
001 7820788*PED 04/27/2025
001 7923536 12/09/2023
U-1117 TREATMENT OF BREAST CANCER
U-1290 TREATMENT OF LUNG CANCER
U-1434 TREATMENT OF PANCREATIC CANCER
04/15/2011
001 7923536*PED 06/09/2024
001 8034375 08/13/2026
U-1290 TREATMENT OF LUNG CANCER
10/24/2012
001 8034375*PED 02/13/2027
001 8138229 12/09/2023 DP
U-1092 TREATMENT OF BREAST CANCER
U-1290 TREATMENT OF LUNG CANCER
U-1434 TREATMENT OF PANCREATIC CANCER
03/27/2012
001 8138229*PED 06/09/2024
001 8268348 02/21/2026
U-1290 TREATMENT OF LUNG CANCER
10/24/2012
001 8268348*PED 08/21/2026
001 8314156 12/09/2023
U-1290 TREATMENT OF LUNG CANCER
U-1434 TREATMENT OF PANCREATIC CANCER
11/28/2012
001 8314156*PED 06/09/2024
001 8853260*PED 04/10/2021
001 9101543 02/21/2026
U-1434 TREATMENT OF PANCREATIC CANCER
08/18/2015
001 9101543*PED 08/21/2026
001 9393318 03/04/2032
U-1290 TREATMENT OF LUNG CANCER
08/22/2016
001 9393318*PED 09/04/2032
001 9511046 01/12/2034
U-1434 TREATMENT OF PANCREATIC CANCER
12/29/2016
001 9511046*PED 07/12/2034
001 9597409 03/04/2032
U-1290 TREATMENT OF LUNG CANCER
04/17/2017
001 9597409*PED 09/04/2032

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
ODE-52TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS AS FIRST-LINE TREATMENT, IN COMBINATION WITH GEMCITABINE.
*PED PEDIATRIC EXCLUSIVITY
03/06/2021
001
M-14ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
COMPETITIVE GENERIC THERAPY
12/06/2022
001
M-14ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
*PED PEDIATRIC EXCLUSIVITY
06/06/2023

 

 


View a list of all patent use codes
View a list of all exclusivity codes

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English