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CABAZITAXEL

NDA

CABAZITAXEL | N207949 | ACCORD HEALTHCARE INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Anne A. Shirinian-Orlando FDA-2018-P-2749 · 4 docket documents Anne A. Shirinian-Orlando filed this petition under Section 355(e) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA issue strict dosage and administration guidelines for prostate cancer chemotherapy medications including Zytiga (abiraterone acetate), Jevtana (cabazitaxel), and Xta	Other	2018-07-18	Open	Anne A. Shirinian-Orlando

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

96 trials from ClinicalTrials.gov — 2 recruiting, 5 active, 56 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer NCT02703623	Phase 2	Active	M.D. Anderson Cancer Center	196	2016-05-18 → 2028-03-31
Enzalutamide and Cabazitaxel in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer NCT02522715	Phase 1/2	Active	OHSU Knight Cancer Institute	37	2015-08-13 → 2027-01-01
Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer Previously Treated With Docetaxel NCT03419234	Phase 2	Active	ECOG-ACRIN Cancer Research Group	223	2018-04-26 → 2028-04-01
Intravesical Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the Treatment Urothelial Carcinoma of the Bladder NCT02202772	Phase 1/2	Active	Guarionex J. Decastro	51	2014-12-01 → 2028-04
A Phase III of Cabazitaxel and Pelvic Radiotherapy in Localized Prostate Cancer and High-risk Features of Relapse NCT01952223	Phase 3	Active	UNICANCER	761	2013-12 → 2041-07
ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer NCT03903835	Phase 3	Recruiting	Karolinska Institutet	750	2019-02-01 → 2026-12
A Randomised Trial of Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin (CDMS) Plus Surgery for Prostate Cancer Patients NCT03258320	Phase 2/3	Recruiting	Shanghai Jiao Tong University School of Medicine	300	2015-01 → 2027-12
Phase I Cabazitaxel, Mitoxantrone, and Prednisone Metastatic Castration-Resistant Prostate Cancer NCT01594918	Phase 1	Completed	Rahul Aggarwal	25	2012-06 → 2017-06-23
Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer NCT01308567	Phase 3	Completed	Sanofi	1,168	2011-05-05 → 2018-05
A Dose Finding Study of XRP6258 in Patients With Advanced Solid Tumors NCT01755390	Phase 1	Completed	Sanofi	42	1999-10 → 2002-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain18 active DMFs2 inactive

16 active API suppliers hold Drug Master Files for this ingredient.

SANOFI WINTHROP INDUSTRIECABAZITAXEL ACETONE SOLVATE

DMF 234962010

SICHUAN XIELI PHARMACEUTICAL CO LTDCABAZITAXEL

DMF 264622012

SHANDONG ANHONG PHARMACEUTICAL CO LTDCABAZITAXEL

DMF 274412013

MSN LABORATORIES PRIVATE LTDCABAZITAXEL [ROUTE CODE "CZ"]

DMF 278312014

DR REDDYS LABORATORIES LTDCABAZITAXEL

DMF 278952014

INTAS PHARMACEUTICALS LTDCABAZITAXEL (AMORPHOUS)

DMF 279782014

TAPI NL BVCABAZITAXEL

DMF 281012014

HETERO LABS LTDCABAZITAXEL

DMF 281592014

LAURUS LABS LTDCABAZITAXEL

DMF 282932014

MSN LABORATORIES PRIVATE LTDCABAZITAXEL [ROUTE CODE - ''CL'']

DMF 293642015

TIANJIN WEIJIE PHARMACEUTICAL CO LTDCABAZITAXEL

DMF 311372016

SHILPA PHARMA LIFESCIENCES LTDCABAZITAXEL

DMF 330872020

INDENA SPACABAZITAXEL

DMF 348092020

YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTDCABAZITAXEL "YUNG SHIN"

DMF 348872020

SICHUAN ELIXIR PHARMACEUTICAL CO LTDCABAZITAXEL

DMF 396452024

SHANDONG NEW TIME PHARMACEUTICAL CO LTDCABAZITAXEL

DMF 398302024

INDENA SPACABAZITAXEL ACETONE

DMF 410552025

JIANGSU XIDI PHARMACEUTICALS CO LTDCABAZITAXEL

DMF 430072025

POLYMED THERAPEUTICS INCInactiveCABAZITAXEL MONOHYDRATE DRUG SUBSTANCE

DMF 257692012

POLYMED THERAPEUTICS INCInactiveCABAZITAXEL ETHYL ACETATE SOLVATE DRUG SUBSTANCE

DMF 273392013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Oct 11, 2024	SUPPL -2	View Letter (PDF)
Dec 30, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 60MG/3ML (20MG/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Dec 29, 2021

No patent or exclusivity listings for this strength.