Paclitaxel Injection

Brand(s)
Abraxane
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Abraxis Bioscience, Llc (2015-07-27)
Oldest Current Product
2005-02-10
License(s)
NDA
RxNORM
INJECTION\PACLITAXEL
FDAOB
IV (INFUSION)\FOR SUSPENSION\PACLITAXEL\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION\PACLITAXEL
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION\PACLITAXEL

product(s) by strength(s)

paclitaxel 100 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1688170134AbraxaneNDAAbraxis Bioscience, Llc2005-02-10PACLITAXELINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SUSPENSIONNDA02166024d10449-2936-4cd3-b7db-a7683db721e4

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA021660ABRAXANEABRAXIS BIOSCIENCE LLC2005-01-07p8268348, TREATMENT OF LUNG CANCER
p8853260, SUBSTANCE
p7758891, TREATMENT OF PANCREATIC CANCER
p9101543, TREATMENT OF PANCREATIC CANCER
p7820788, TREATMENT OF PANCREATIC CANCER/ TREATMENT OF BREAST CANCER/ TREATMENT OF LUNG CANCER, SUBSTANCE
pRE41884, TREATMENT OF PANCREATIC CANCER/ TREATMENT OF LUNG CANCER/ TREATMENT OF BREAST CANCER
p8314156, TREATMENT OF PANCREATIC CANCER/ TREATMENT OF LUNG CANCER
p8138229, TREATMENT OF PANCREATIC CANCER/ TREATMENT OF BREAST CANCER/ TREATMENT OF LUNG CANCER, SUBSTANCE
p8034375, TREATMENT OF LUNG CANCER
p7923536, TREATMENT OF PANCREATIC CANCER/ TREATMENT OF LUNG CANCER/ TREATMENT OF BREAST CANCER
FIRST-LINE TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER [2015-10-11]
ORPHAN DRUG EXCLUSIVITY [2020-09-06]
FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC ADENOCARACINOMA OF THE PANCREAS [2016-09-06]
NDA021660_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA021660_001RXPACLITAXEL (100MG/VIAL)FOR SUSPENSIONTrue2005-01-07ABRAXANE

patent(s)

#idexpiration dateapplication(s)
1p7758891 (view patent)2026-02-21NDA021660
2p7820788 (view patent)2024-03-03NDA021660
3p7923536 (view patent)2023-12-09NDA021660
4p8034375 (view patent)2026-08-13NDA021660
5p8138229 (view patent)2023-12-09NDA021660
6p8268348 (view patent)2026-02-21NDA021660
7p8314156 (view patent)2023-12-09NDA021660
8p8853260 (view patent)2020-08-14NDA021660
9p9101543 (view patent)2026-02-21NDA021660
10pRE41884 (view patent)2016-08-14NDA021660

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
124d10449-2936-4cd3-b7db-a7683db721e4 (view SPL)These highlights do not include all the information needed to use ABRAXANE safely and effectively. See full prescribing information for ABRAXANE. ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)(albumin-bound) Initial U.S. Approval: 2005prescriptionHuman PrescriptionAbraxis Bioscience, Llc2015-07-2724688170134

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII