Viewing data from:

DOCETAXEL

NDA

DOCETAXEL | N205934 | SHILPA MEDICARE LTD

3 strengths4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)Today

2027

2028

2029

2030

2031

2032

2033

2034

Today

Sep. 30, 2033

Sep. 30, 2033

Sep. 30, 2033

Aug. 7, 2031

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 HYMAN, PHELPS & MCNAMARA, P.C. FDA-2020-P-1844 · 2 docket documents The law firm Hyman, Phelps & McNamara filed this citizen petition on behalf of an unnamed party requesting that FDA amend the Orange Book to designate Docetaxel Injection (20mg/ml, 80mg/4ml, and 160mg/8ml) approved under NDA 205934 as an additional Reference Listed Drug and Reference Standard. The p	505(q)	2020-09-03	Open	HYMAN, PHELPS & MCNAMARA, P.C.

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

Clinical Trials

500 trials from ClinicalTrials.gov, 56 active, 444 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Gemcitabine, Docetaxel, and Hydroxychloroquine in Treating Participants With Recurrent or Refractory Osteosarcoma NCT03598595	Phase 1/2	Active	M.D. Anderson Cancer Center	31	2019-01-28 → 2027-05-31
REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer NCT03951831	Phase 2	Active	Mark Stein	26	2019-05-16 → 2028-04
Adjuvant Palbociclib in Elderly Patients With Breast Cancer NCT03609047	Phase 2	Active	European Organisation for Research and Treatment of Cancer - EORTC	366	2019-06-14 → 2026-09-30
Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer NCT00295893	Phase 2	Active	City of Hope Medical Center	121	2005-09-27 → 2026-08-11
Trial of Laryngeal Preservation Comparing Induced CT Followed by RT vs CT Concomitant to RT NCT03340896	Phase 3	Active	Groupe Oncologie Radiotherapie Tete et Cou	256	2015-06-25 → 2028-11
Pembrolizumab With Chemotherapy for Poorly Chemo-responsive Thyroid and Salivary Gland Tumors NCT03360890	Phase 2	Active	University of Chicago	46	2018-03-26 → 2032-09
SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer NCT02299999	Phase 2	Active	UNICANCER	1,460	2014-04-07 → 2025-12
A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)NCT02817633	Phase 1	Active	Tesaro, Inc.	463	2016-07-08 → 2027-03-01
Taxane and Taxane-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer NCT04001829	Phase 2	Active	ECOG-ACRIN Cancer Research Group	249	2019-08-09 → 2027-03-31
Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer NCT00430183	Phase 3	Active	Alliance for Clinical Trials in Oncology	788	2007-05-08 → 2030-10

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

4 letters from Drugs@FDA

Date	Submission	Document
Jul 7, 2023	SUPPL -6	View Letter (PDF)
Aug 5, 2021	SUPPL -5	View Letter (PDF)
Feb 20, 2020	SUPPL -3	View Letter (PDF)
Dec 23, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 20MG/ML (20MG/ML)

RLDAP

4 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 22, 2015

Patents (4) · 9 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8940786	Sep 30, 2033	—	—	Yes		—
9308195	Sep 30, 2033	—	—	Yes	—	—
9763880	Sep 30, 2033	—	—	—		—
10842770	Aug 7, 2031	—	—	Yes		—

#002 — 80MG/4ML (20MG/ML)

RLDAP

4 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 22, 2015

#003 — 160MG/8ML (20MG/ML)

RLDAP

4 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 22, 2015