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Details for Generic Name: docetaxel

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Docetaxel is the generic ingredient in three branded drugs marketed by Apotex Inc, Sandoz, Sun Pharma Global, Hospira Inc, Eagle Pharms, Sanofi Aventis Us, Actavis Inc, Pfizer Labs, Teva Pharms Usa, Dr Reddys Labs Ltd, and Accord Hlthcare, and is included in eleven NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has ten patent family members in ten countries.

There are thirty-eight drug master file entries for docetaxel. Nine suppliers are listed for this compound.

Summary for Generic Name: docetaxel

Tradenames:3
Patents:1
Applicants:11
NDAs:11
Drug Master File Entries: see list38
Suppliers / Packaging: see list35

Pharmacology for Ingredient: docetaxel

Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition

Clinical Trials for: docetaxel

Study of Usefulness of Genotyping to Predict Docetaxel Exposure and Adverse Events
Status: Completed Condition: CYP3A Phenotyping; CYP3A5 and MDR1 Genotyping; Docetaxel Toxicity; Associations Between Genetic Data and Docetaxel Toxicity

Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer
Status: Recruiting Condition: Hormone Refractory Prostate Cancer

The Effects Of GW679769 (Casopitant) On The Pharmacokinetics Of Docetaxel In Subjects With Cancer
Status: Completed Condition: Nausea and Vomiting, Chemotherapy-Induced; Cancer

Randomized Study of Docetaxel +/- ZD6474 in Metastatic TCC
Status: Completed Condition: Transitional Cell Carcinoma; Bladder Cancer

Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design
Status: Recruiting Condition: Squamous Cell Carcinoma

A Phase 1b Dose Escalation Trial of PSK®/Placebo With Docetaxel to Treat Metastatic Castration-resistant Prostate Cancer
Status: Withdrawn Condition: Prostatic Neoplasms

A Multiple-Dose Study of RhuMab 2C4 and Docetaxel in the Treatment of Advanced Solid Tumors
Status: Completed Condition: Solid Tumor

Phase 1/2 Study of Vascular Disrupting Agent NPI-2358 + Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer
Status: Completed Condition: Cancer

RAD001 Plus Docetaxel in Patients With Metastatic Breast Cancer
Status: Terminated Condition: Breast Cancer

Phase II: RAD001 Plus Docetaxel in Patients With Metastatic Breast Cancer
Status: Withdrawn Condition: Breast Cancer

Docetaxel and Lycopene in Metastatic Prostate Cancer
Status: Active, not recruiting Condition: Adenocarcinoma of the Prostate

Docetaxel and Trastuzumab With or Without Carboplatin in Treating Women With HER2-Positive Breast Cancer
Status: Completed Condition: Breast Cancer

Pharmacokinetic Study of CKD-810 and Taxotere to Treat Patient With Advanced Solid Cancer
Status: Completed Condition: Advanced Solid Cancers

Induction Study of Cisplatin, Docetaxel, and Nintedanib Stage IB-IIIA Non-Small Cell Lung Cancer (NCLC)
Status: Recruiting Condition: Lung Cancer

Randomized, Multi-center, Open-label, Study of PR104 Versus PR104/Docetaxel in Non-Small Cell Lung Cancer (NSCLC)
Status: Terminated Condition: Non-Small Cell Lung Cancer

Safety Study of a New Schedule of Capecitabine and Docetaxel to Treat Cancers
Status: Completed Condition: Metastatic Breast Cancer

Study to Evaluate Combination Treatment of MGCD0103 and Docetaxel (Taxotere®) for Subjects With Advanced Cancer Tumors
Status: Terminated Condition: Breast Cancer; Lung Cancer; Pulmonary Cancer; Non-Small-Cell Lung Carcinoma; Prostate Cancer; Prostatic Cancer; Gastric Cancer; Stomach Cancer

BIBF 1120 + Docetaxel (Japan) in Patients With Advanced Non-small-cell Lung Cancer, Phase I
Status: Completed Condition: Carcinoma, Non-Small-Cell Lung

A Phase II Study of Docetaxel Plus Carboplatin in Chemonaive Hormone-Refractory Prostate Cancer (HRPC) Patients
Status: Completed Condition: Hormone-Refractory Prostate Cancer

Study Comparing Concomitant Docetaxel + Gemcitabine to Sequential Therapy of Docetaxel Followed by Gemcitabine
Status: Completed Condition: Breast Cancer

Feasibility of a Chemotherapy With Docetaxel-Prednisone for Castration-resistant Metastatic Prostate Cancer Elderly Patients
Status: Recruiting Condition: Prostate Cancer

Docetaxel Combined With Ketoconazole in Treatment of Breast Cancer
Status: Completed Condition: Metastatic Breast Cancer

Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Naïve Prostate Cancer Patients
Status: Recruiting Condition: Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer

Erlotinib and Docetaxel With Concomitant Boost Radiation Therapy (XRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)
Status: Completed Condition: Head and Neck Cancer

RAD001 (Everolimus) + Docetaxel + Cisplatin as Induction Chemotherapy in Patients With Local-Regional Advanced Head and Neck Cancer
Status: Completed Condition: HEAD & NECK Cancer

A Double-blind Study Evaluating IPI-504 and Docetaxel in Patients With Non-Small Cell Lung Cancer
Status: Completed Condition: Non Small Cell Lung Cancer

A Study of Alpharadin With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer (CRPC)
Status: Completed Condition: Bone Metastases; Castration-Resistant Prostate Cancer

Docetaxel With or Without AZD6244 in Melanoma
Status: Active, not recruiting Condition: Melanoma

Biweekly Schedule of Docetaxel and Cisplatin in High Risk Patients With Unresectable Non-small Cell Lung Cancer (NSCLC)
Status: Completed Condition: Non-small Cell Lung Cancer

Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
Status: Completed Condition: Lung Cancer

Docetaxel Lipid Microsphere (DT-LM) for Injection in Chemotherapy Patients
Status: Recruiting Condition: Advanced Cancer

Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer
Status: Completed Condition: Pancreatic Cancer

A Study of CNTO 328 in Patients With Metastatic Hormone-Refractory Prostate Cancer
Status: Completed Condition: Prostatic Neoplasms

Observational Study of Docetaxel Exposure in Metastatic Prostate Cancer Patients
Status: Recruiting Condition: Prostate Cancer

Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer (NSCLC)
Status: Active, not recruiting Condition: Non Small Cell Lung Cancer (NSCLC)

Cisplatin and Docetaxel Plus Docetaxel and Radiotherapy With Amifostine for Squamous Cell Carcinoma of the Head and Neck
Status: Completed Condition: Cancer of Head and Neck; Head Cancer; Head and Neck Cancer; Neck Cancer; Neck Neoplasms

A Phase 1b/2, Study of Pegylated Recombinant Human Hyaluronidase Combined With Docetaxel Versus Docetaxel Alone in Subjects With Recurrent Previously Treated Locally Advanced or Metastatic NSCLC.
Status: Recruiting Condition: Non Small Cell Lung Cancer

Pharmacokinetic Study of Docetaxel-PNP and Taxotere to Treat Patient With Advanced Solid Cancer
Status: Not yet recruiting Condition: Solid Tumor

A Study of Ramucirumab and Docetaxel in Participants With Solid Tumors
Status: Completed Condition: Malignant Solid Tumor

Docetaxel/Carboplatin Versus Docetaxel/Caelyx in Pretreated Patients With Ovarian Carcinoma
Status: Terminated Condition: Ovarian Cancer

Trial of Neoadjuvant Endostar, Docetaxel and Epirubicin for Patients With Breast Cancer
Status: Recruiting Condition: Breast Cancer

Trial Using Docetaxel Cytoxan in Breast Cancers With High Recurrence Scores
Status: Terminated Condition: Breast Neoplasms; Breast Cancer; Cancer of the Breast

VEGF Trap and Docetaxel in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
Status: Completed Condition: Fallopian Tube Cancer; Malignant Tumor of Peritoneum; Recurrent Ovarian Epithelial Cancer

Study of Dasatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer
Status: Completed Condition: Metastatic Prostate Cancer

Docetaxel, Radiation Therapy, and Prednisone in Treating Patients Who Have Undergone Surgery For Prostate Cancer
Status: Active, not recruiting Condition: Prostate Cancer

Iressa and Taxotere Study in Patients With Metastatic Urothelial Cancer
Status: Terminated Condition: Bladder Cancer

A Study of CriPec® Docetaxel Given to Patients With Solid Tumours
Status: Recruiting Condition: Cancer; Metastatic Cancer; Solid Tumors

Study of PX-866 and Docetaxel in Solid Tumors
Status: Completed Condition: Non Small Cell Lung Cancer (NSCLC); Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Sunitinib + Docetaxel as Second-line Treatment in Gastric Cancer
Status: Completed Condition: Advanced Gastric Cancer

Genetic Expression and Prediction of Response to Neoadjuvant Docetaxel or Doxorubicin in Locally Advanced Breast Cancer
Status: Completed Condition: Breast Cancer

Phase II Study of Docetaxel for Clinically Asymptomatic High Risk Prostate Cancer Patients
Status: Terminated Condition: Prostate Cancer

Therapy With Docetaxel and ZD1839 for Patients Who Have Advanced Breast Cancer
Status: Completed Condition: Breast Neoplasms

Primary Chemotherapy With Docetaxel-Capecitabine and Doxorubicin-Cyclophosphamide in Breast Cancer
Status: Completed Condition: Breast Cancer; Breast Neoplasm

Docetaxel With or Without Ascorbic Acid in Treating Patients With Metastatic Prostate Cancer
Status: Not yet recruiting Condition: Hormone-Resistant Prostate Cancer; Metastatic Prostate Carcinoma; Stage IV Prostate Cancer

Phase III Trial Of Docetaxel Versus Docetaxel Plus ZD1839 In Head And Neck Cancer
Status: Terminated Condition: Recurrent Head and Neck Cancer; Metastatic Head and Neck Cancer

Pazopanib, Docetaxel, Prednisone Prostate
Status: Active, not recruiting Condition: Prostate Cancer

Phase I Study of IPI-504 and Docetaxel in Patients With Advanced Solid Tumors
Status: Completed Condition: Solid Tumors

Sublingual Anvirzel in Advance Non-Small Cell Lung Cancer (NSCLC)
Status: Withdrawn Condition: Chemotherapeutic Agent Toxicity; Lung Cancer

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)
Status: Active, not recruiting Condition: Squamous Cell Non-small Cell Lung Cancer

Dose-Dense Docetaxel Before or After Doxorubicin/Cyclophosphamide in Axillary Node-Positive Breast Cancer
Status: Completed Condition: Breast Cancer

LDFWART With Docetaxel in Patients With Platinum-Resistant Recurrent Ovarian Carcinoma
Status: Recruiting Condition: Ovarian Cancer; Ovarian Carcinoma; Recurrent Ovarian Cancer; Recurrent Ovarian Carcinoma

Sirolimus, Docetaxel, and Carboplatin in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Status: Not yet recruiting Condition: Hormone-Resistant Prostate Cancer; Metastatic Prostate Carcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer

Safety Profile, MTD, and PK Profile Studies of ABT-263 When Administered in Combination With Standard and Weekly Regimens of Docetaxel in Subjects With Cancer
Status: Completed Condition: Solid Tumor

Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive
Status: Completed Condition: Breast Cancer

Gefitinib or Docetaxel as Second Line Therapy for Wild-type Epidermal Growth Factor Receptor (EGFR) NSCLC
Status: Recruiting Condition: Non-small Cell Lung Cancer

Carboplatin and Paclitaxel With or Without Bevacizumab Compared to Docetaxel, Carboplatin, and Paclitaxel in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Carcinoma (Cancer)
Status: Completed Condition: Brenner Tumor; Fallopian Tube Cancer; Ovarian Carcinosarcoma; Ovarian Clear Cell Cystadenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mixed Epithelial Carcinoma; Ovarian Mucinous Cystadenocarcinoma; Ovarian Serous Cystadenocarcinoma; Ovarian Undifferentiated Adenocarcinoma; Primary Peritoneal Cavity Cancer; Stage II Ovarian Epithelial Cancer; Stage III Ovarian Epithelial Cancer; Stage IV Ovarian Epithelial Cancer

An Open, Randomized, Multicentre, Phase II Pilot Study
Status: Completed Condition: Non-Small Cell Lung Cancer

Trastuzumab (Herceptin), Bevacizumab, and Docetaxel (Taxotere) Trial in Stage IV Metastatic Breast Cancer (MBC) Patients
Status: Active, not recruiting Condition: Breast Cancer

Safety and Efficacy Study of GM-CSF, Thalidomide Plus Docetaxel in Prostate Cancer
Status: Terminated Condition: Prostatic Neoplasms

A Study Comparing AT-101 in Combination With Docetaxel and Prednisone Versus Docetaxel and Prednisone in Men With Chemotherapy-Naïve Metastatic Hormone Refractory Prostate Cancer (HRPC)
Status: Completed Condition: Hormone Refractory Prostate Cancer

Study of AXL1717 Compared to Docetaxel to Treat Squamous Cell Carcinoma or Adenocarcinoma of the Lung
Status: Completed Condition: Non-small-cell Lung Cancer; Squamous Cell Carcinoma; Adenocarcinoma of the Lung

Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®.
Status: Completed Condition: Carcinoma, Non-Small-Cell Lung

Neoadjuvant Cisplatin/Docetaxel (CDDP/TXT) and Chemoradiation for Head and Neck Cancer
Status: Recruiting Condition: Head and Neck Neoplasms

Nimotuzumab Plus Docetaxel in Chemotherapy-Refractory/Resistant Patients With Advanced Non-Small-Cell Lung Cancer
Status: Terminated Condition: Advanced Non-Small Cell Lung Cancer

Hormonal Ablation, Imatinib Mesylate and Docetaxel for Patients With Prostate Cancer
Status: Completed Condition: Prostate Cancer

VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Docetaxel in Treating Patients With Solid Tumors
Status: Recruiting Condition: Unspecified Adult Solid Tumor, Protocol Specific

A Phase 1, Dose Escalation Study to Assess the Safety and Tolerability of ASP9853 With Either Docetaxel or Paclitaxel in Patients With Advanced Non-hematologic Malignancies
Status: Terminated Condition: Pharmacokinetics of ASP9853; Non-hematologic Malignancies

Phase 2 Study of EC145 Alone Versus EC145+Docetaxel Versus Docetaxel Alone in Participants With FR(++) 2nd Line Non Small Cell Lung Cancer
Status: Completed Condition: Non Small Cell Lung Cancer

Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer
Status: Completed Condition: Non Small Cell Lung Cancer

Docetaxel and S-1 for Advanced Esophageal Cancer
Status: Recruiting Condition: Esophageal Neoplasms

Docetaxel and Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Breast Cancer
Status: Completed Condition: Breast Cancer

Plinabulin (P) + Docetaxel (D) vs D as 2nd-Line Chemo in Patients With Advanced NSCLC With at Least 1 Large Lung Lesion
Status: Recruiting Condition: Non-Small Cell Lung Cancer

Docetaxel, Oxaliplatin and S-1 (DOS) for Advanced Gastric Cancer
Status: Completed Condition: Stomach Neoplasms

Lapatinib in Combination With Docetaxel in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer
Status: Completed Condition: Metastatic Breast Cancer

A Phase 2 Study of B-701 in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma
Status: Recruiting Condition: Locally Advanced or Metastatic Urothelial Cell Carcinoma; Urinary Bladder Disease; Urological Diseases

Phase1b to Evaluate Safety of AMG706 in Combination With Paclitaxel or Docetaxel for Breast Cancer
Status: Completed Condition: Locally Recurrent and Metastatic Breast Cancer

Safety & Efficacy of Three Docetaxel-Based Chemotherapy Regimens Plus Bevacizumab With or Without Trastuzumab for Adjuvant Treatment of Patients With Breast Cancer
Status: Completed Condition: Breast Cancer

Phase I Study of LB-100 With Docetaxel in Solid Tumors
Status: Recruiting Condition: Tumors; Neoplasms; Cancer

A Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Metastatic Breast Cancer
Status: Recruiting Condition: Metastatic Breast Cancer

Binimetinib With Docetaxel in Treating Patients With Previously Treated, Stage IV Non-small Cell Lung Cancer
Status: Not yet recruiting Condition: Recurrent Non-Small Cell Lung Carcinoma; Stage IV Non-Small Cell Lung Cancer

Docetaxel and Sirolimus in Patients With Advanced Malignancies
Status: Completed Condition: Advanced Cancer

OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer
Status: Active, not recruiting Condition: Head and Neck Cancer

The ELDORADO (Eligard®, Docetaxel and Radiotherapy) Study
Status: Active, not recruiting Condition: Prostatic Neoplasms

Phase II Study of Trastuzumab Plus Docetaxel and Capecitabine For First Line Treatment of Her2-Positive Advanced Gastric Cancer
Status: Recruiting Condition: Stomach Neoplasms; Neoplasms Metastasis; ERBB2 Gene Amplification

Docetaxel and Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer or Other Solid Tumors
Status: Completed Condition: Lung Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Randomized Phase III Trial With Docetaxel Plus Epirubicine Versus Docetaxel Plus Capecitabine for Metastatic Breast Cancer
Status: Completed Condition: Breast Cancer

A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer
Status: Terminated Condition: Breast Cancer Metastatic

Sorafenib, Docetaxel, and Cisplatin in Treating Patients With Metastatic or Advanced Gastric or Gastroesophageal Junction Cancer
Status: Completed Condition: Adenocarcinoma of the Gastroesophageal Junction; Metastatic Gastric Cancer; Advanced Unresectable Gastric Cancer

Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Status: Active, not recruiting Condition: Adenocarcinoma of the Prostate; Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer

Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.
Status: Active, not recruiting Condition: Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eagle Pharms
DOCETAXEL
docetaxel
SOLUTION;IV (INFUSION)205934-001Dec 22, 2015RXNo8,940,786<disabled>Y <disabled>
Accord Hlthcare
DOCETAXEL
docetaxel
INJECTABLE;INJECTION201195-002Jun 8, 2011RXNo<disabled><disabled>
Pfizer Labs
DOCETAXEL
docetaxel
INJECTABLE;INJECTION202356-001Mar 13, 2014RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: docetaxel

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-003Aug 3, 20104,814,470*PED<disabled>
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-001May 14, 19965,698,582*PED<disabled>
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-004Aug 2, 20104,814,470*PED<disabled>
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International Patent Family for Ingredient: docetaxel

Country Document Number Publication Date
Australia2013327563Apr 16, 2015
Philippines12015500681May 18, 2015
South Korea20150066542Jun 16, 2015
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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