Viewing data from:

JEVTANA KIT

NDA

CABAZITAXEL | N201023 | SANOFI AVENTIS US INC

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Expired (1)Active (4)TodayPED (+6 mo)IPRPTAB Challenge

2026

2027

2028

2029

2030

2031

Today

Jun. 10, 2026

Apr. 27, 2031IPR

Apr. 27, 2031

Apr. 27, 2031

Apr. 27, 2031

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2016-00712	8927592	IPR	Mylan Laboratories Limited et al.	Final Written Decision	2016-03-15	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

4 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Sanofi-Aventis U.S. LLC, et al. v. Sandoz Inc. 1:2020cv00804 2 patentsANDA 207736, 207619, 207718, 207591cabazitaxel	D. Del.	2020-06-12	Terminated 2023-07-05	—
SANOFI-AVENTIS U.S. LLC et al v. APOTEX CORP. et al 3:2015cv00287 2 patentsANDA 207736Cabazitaxel	D.N.J.	2015-01-14	Terminated 2017-09-26	—
SANOFI-AVENTIS U.S. LLC et al v. BRECKENRIDGE PHARMACEUTICAL, INC. 3:2015cv00289 2 patentsANDA 207619cabazitaxel	D.N.J.	2015-01-14	Terminated 2018-03-05	—
SANOFI-AVENTIS U.S. LLC et al v. FRESENIUS KABI USA, LLC 3:2014cv07869 2 patentscabazitaxel	D.N.J.	2014-12-17	Terminated 2018-03-05	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Jevtana (2023)

Total Spending

$6.1M

Total Claims

427

Beneficiaries

Avg Cost/Unit

$9358.85

Spending Trend

$3.6M(2019)→$3.9M(2020)→$4.9M(2021)→$5.4M(2022)→$6.1M(2023)

YoY Change:+5.3%

5yr CAGR:+5.8%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

12 letters from Drugs@FDA

Date	Submission	Document
Jul 10, 2023	SUPPL -26	View Letter (PDF)
Feb 17, 2021	SUPPL -25	View Letter (PDF)
Dec 22, 2020	SUPPL -24	View Letter (PDF)
Jan 11, 2018	SUPPL -21	View Letter (PDF)
Sep 19, 2017	SUPPL -19	View Letter (PDF)
May 19, 2017	SUPPL -20	View Letter (PDF)
Sep 15, 2016	SUPPL -17	View Letter (PDF)
Jun 22, 2015	SUPPL -15	View Letter (PDF)
Nov 21, 2014	SUPPL -11	View Letter (PDF)
Apr 30, 2013	SUPPL -7	View Letter (PDF)
Oct 9, 2012	SUPPL -3	View Letter (PDF)
Jun 21, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 60MG/1.5ML (40MG/ML)

RLDAP

5 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jun 17, 2010

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7241907	Dec 10, 2025PED: Jun 10, 2026	PED	Yes	—	—	—
8927592	Oct 27, 2030PED: Apr 27, 2031	PED	—	—		—
10583110	Oct 27, 2030PED: Apr 27, 2031	PED	—	—		—
10716777	Oct 27, 2030PED: Apr 27, 2031	PED	—	—		—
12453712	Oct 27, 2030PED: Apr 27, 2031	PED	—	—		—