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CABAZITAXEL

ANDA

CABAZITAXEL | A207619 | BRECKENRIDGE PHARMACEUTICAL INC

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

2 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. BRECKENRIDGE PHARMACEUTICAL, INC. 3:2015cv00289 2 patentsANDA 207619cabazitaxel	D.N.J.	2015-01-14	Terminated 2018-03-05	—

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

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

1 letter from Drugs@FDA

Date	Submission	Document
Aug 1, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 60MG/1.5ML (40MG/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jun 23, 2022

No patent or exclusivity listings for this strength.