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TAXOTERE

NDA

DOCETAXEL | N020449 | SANOFI AVENTIS US LLC

4 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

21 trials from ClinicalTrials.gov — 16 recruiting, 4 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Trametinib and Docetaxel in Treating Patients With Recurrent or Stage IV KRAS Mutation Positive Non-small Cell Lung Cancer NCT02642042	Phase 2	Active	National Cancer Institute (NCI)	60	2016-07-18 → 2027-03-03
A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies NCT06120075	Phase 1	Active	Arcus Biosciences, Inc.	91	2024-01-19 → 2026-11
Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer NCT05132075	Phase 3	Active	Novartis Pharmaceuticals	95	2022-06-15 → 2026-09-23
Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy NCT04655976	Phase 2/3	Active	GlaxoSmithKline	758	2020-12-08 → 2027-03-30
A Study of LM-168 Combined With Other Anti-tumor Treatments in Participants With Advanced Solid Tumors NCT07669415	Phase 2	Not Yet Recruiting	LaNova Medicines Limited	108	2026-06-30 → 2028-12-15
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer NCT07667400	Phase 1/2	Not Yet Recruiting	National Cancer Institute (NCI)	120	2026-07-07 → 2037-10-01
The Efficacy of Combined Peripheral Blood CTCs and Serum HER2 Detection in Docetaxel-based Treatment for HER2 Low-expression Breast Cancer NCT07670182	—	Not Yet Recruiting	Tianjin Medical University Cancer Institute and Hospital	100	2026-06-15 → 2031-01-01
Neoadjuvant Docetaxel, Cisplatin, and Dual Immunotherapy for Sinonasal Carcinoma NCT07645846	Phase 2	Not Yet Recruiting	Sun Yat-sen University	23	2026-07-31 → 2030-08-01
A Study to Evaluate GFH375 Versus Docetaxel in Participants With Non-Small Cell Lung Cancer With KRAS G12D Mutation NCT07668752	Phase 3	Not Yet Recruiting	Genfleet Therapeutics (Shanghai) Inc.	300	2026-07-15 → 2031-04-30
Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations NCT07291037	Phase 3	Recruiting	AstraZeneca	400	2025-10-31 → 2029-01-29

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

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

34 letters from Drugs@FDA

Date	Submission	Document
Jan 19, 2023	SUPPL -86	View Letter (PDF)
Jun 14, 2022	SUPPL -85	View Letter (PDF)
May 19, 2020	SUPPL -84	View Letter (PDF)
Dec 20, 2019	SUPPL -83	View Letter (PDF)
Jun 7, 2019	SUPPL -80	View Letter (PDF)
Jun 7, 2019	SUPPL -82	View Letter (PDF)
Oct 15, 2018	SUPPL -79	View Letter (PDF)
Dec 15, 2015	SUPPL -75	View Letter (PDF)
Nov 17, 2014	SUPPL -73	View Letter (PDF)
Dec 16, 2013	SUPPL -71	View Letter (PDF)
Jun 27, 2013	SUPPL -69	View Letter (PDF)
Dec 20, 2011	SUPPL -65	View Letter (PDF)
Sep 12, 2011	SUPPL -64	View Letter (PDF)
Jun 8, 2010	SUPPL -43	View Letter (PDF)
May 18, 2010	SUPPL -59	View Letter (PDF)
Apr 23, 2010	SUPPL -44	View Letter (PDF)
Apr 23, 2010	SUPPL -53	View Letter (PDF)
Oct 4, 2007	SUPPL -45	View Letter (PDF)
Oct 23, 2006	SUPPL -39	View Letter (PDF)
Jun 8, 2006	SUPPL -36	View Letter (PDF)
Apr 5, 2006	SUPPL -35	View Letter (PDF)
Nov 18, 2005	SUPPL -34	View Letter (PDF)
Aug 15, 2005	SUPPL -33	View Letter (PDF)
Jan 11, 2005	SUPPL -31	View Letter (PDF)
Aug 25, 2004	SUPPL -29	View Letter (PDF)
May 26, 2004	SUPPL -28	View Letter (PDF)
May 29, 2003	SUPPL -16	View Letter (PDF)
Jan 30, 2003	SUPPL -19	View Letter (PDF)
Jan 30, 2003	SUPPL -17	View Letter (PDF)
Jan 30, 2003	SUPPL -22	View Letter (PDF)
Nov 27, 2002	SUPPL -18	View Letter (PDF)
Dec 23, 1999	SUPPL -11	View Letter (PDF)
Jun 22, 1998	SUPPL -5	View Letter (PDF)
Jun 22, 1998	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: May 14, 1996

No patent or exclusivity listings for this strength.

#003 — 20MG/ML (20MG/ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Aug 3, 2010

#004 — 80MG/4ML (20MG/ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Aug 2, 2010

#005 — 160MG/8ML (20MG/ML)

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Apr 13, 2012