Viewing data from:

DOCEFREZ

NDA

DOCETAXEL | N022534 | SUN PHARMACEUTICAL INDUSTRIES LTD

5 strengths0 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for Docefrez (2023)

Total Spending

$2.9M

Total Claims

40,597

Beneficiaries

9,426

ASP Price

$0.69

YoY Change:+41.3%

5yr CAGR:-8.0%

HCPCS: J9171 — Injection, docetaxel, 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain23 active DMFs17 inactive

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

SCINOPHARM TAIWAN LTDDOCETAXEL USP

DMF 200212006

SCINOPHARM TAIWAN LTDDOCETAXEL TRIHYDRATE USP

DMF 209422007

BIOVECTRA INCDOCETAXEL

DMF 215172008

HUBEI HAOSUN PHARMACEUTICAL CO LTDDOCETAXEL ANHYDROUS

DMF 225622009

TAPI NL BVDOCETAXEL

DMF 230542009

CENWAY PHARMACEUTICALS CO LTDDOCETAXEL

DMF 234062009

INDENA SPADOCETAXEL

DMF 238862010

JIANGSU HENGRUI PHARMACEUTICALS CO LTDDOCETAXEL TRIHYDRATE USP

DMF 241752010

PHYTON BIOTECH LLCDOCETAXEL ANHYDROUS

DMF 246752011

DR REDDYS LABORATORIES LTDDOCETAXEL ANHYDROUS

DMF 248542011

FUJIAN SOUTH PHARMACEUTICAL CO LTDDOCETAXEL ANHYDROUS, NON-STERILE, BULK DRUG SUBSTANCE

DMF 252952011

QILU PHARMACEUTICAL CO LTDDOCETAXEL USP

DMF 255762011

LAURUS LABS LTDDOCETAXEL ANHYDROUS, USP (PROCESS-2)

DMF 265952012

YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTDDOCETAXEL TRIHYDRATE

DMF 266522012

MSN LABORATORIES PRIVATE LTDDOCETAXEL ANHYDROUS USP [ROUTE CODE - DL]

DMF 273082013

MSN LABORATORIES PRIVATE LTDDOCETAXEL TRIHYDRATE USP [ROUTE CODE - "DO"]

DMF 274572013

EMCURE PHARMACEUTICALS LTDDOCETAXEL TRIHYDRATE USP (PROCESS II)

DMF 277712014

INTAS PHARMACEUTICALS LTDDOCETAXEL ANHYDROUS USP (PROCESS II)

DMF 287562014

SCINOPHARM TAIWAN LTDDOCETAXEL USP

DMF 300912016

HAINAN YEW PHARMACEUTICAL CO LTDDOCETAXEL

DMF 310712016

INDENA SPADOCETAXEL TRIHYDRATE

DMF 332092018

WUHAN CALMLAND PHARMACEUTICALS CO LTDDOCETAXEL

DMF 368782022

CHONGQING SINTAHO PHARMACEUTICAL CO LTDDOCETAXEL

DMF 372242022

SAI PHYTOCEUTICALS PVT LTDInactiveDOCETAXEL TRIHYDRATE

DMF 207222007

POLYMED THERAPEUTICS INCInactiveDOCETAXEL ANHYDROUS, NON-STERILE BULK DRUG SUBSTANCE

DMF 209612007

POLYMED THERAPEUTICS INCInactiveDOCETAXEL TRIHYDRATE DRUG SUBSTANCE

DMF 210402007

BENZOCHEM LIFESCIENCES PVT LTDInactiveDOCETAXEL ANHYDROUS

DMF 212752008

ACCORD HEALTHCARE INCInactiveDOCETAXEL TRIHYDRATE API

DMF 219302008

LAURUS LABS LTDInactiveDOCETAXEL ANHYDROUS USP

DMF 231382009

QILU PHARMACEUTICAL CO LTDInactiveDOCETAXEL USP

DMF 234582010

FRESENIUS KABI ONCOLOGY LTDInactiveDOCETAXEL

DMF 251032011

ARCH PHARMALABS LTDInactiveDOCETAXEL ANHYDROUS USP

DMF 251422011

ARCH PHARMALABS LTDInactiveDOCETAXEL TRIHYDRATE USP

DMF 251432011

INTAS PHARMACEUTICALS LTDInactiveDOCETAXEL ANHYDROUS USP

DMF 254952011

SAMYANG HOLDINGS CORPInactiveDOCETAXEL ANHYDROUS

DMF 256722012

SAMYANG HOLDINGS CORPInactiveDOCETAXEL TRIHYDRATE

DMF 256782012

EMCURE PHARMACEUTICALS LTDInactiveDOCETAXEL USP

DMF 258042012

SICHUAN XIELI PHARMACEUTICAL CO LTDInactiveDOCETAXEL

DMF 263282012

MAC CHEM PRODUCTS INDIA PVT LTDInactiveDOCETAXEL TRIHYDRATE USP

DMF 265802012

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveDOCETAXEL TRIHYDRATE USP

DMF 274332013

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Aug 23, 2023	SUPPL -17	View Letter (PDF)
Dec 12, 2022	SUPPL -16	View Letter (PDF)
Feb 3, 2021	SUPPL -12	View Letter (PDF)
Feb 26, 2020	SUPPL -11	View Letter (PDF)
Jan 18, 2019	SUPPL -7	View Letter (PDF)
Oct 31, 2014	SUPPL -4	View Letter (PDF)
Jul 20, 2012	SUPPL -2	View Letter (PDF)
May 5, 2011	ORIG -1	View Letter (PDF)
Mar 22, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 20MG/VIAL

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: May 3, 2011

No patent or exclusivity listings for this strength.

#002 — 80MG/VIAL

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 3, 2011

#003 — 20MG/ML (20MG/ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jan 8, 2019

#004 — 80MG/4ML (20MG/ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jan 8, 2019

#005 — 160MG/8ML (20MG/ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jan 8, 2019