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Profile for Tradename: TAXOTERE

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Taxotere is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from two suppliers.

The generic ingredient in TAXOTERE is docetaxel. There are thirty-eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the docetaxel profile page.

Summary for Tradename: TAXOTERE

Patents:0
Applicants:1
NDAs:1
Suppliers / Packagers: see list4

Pharmacology for Tradename: TAXOTERE

Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition

Clinical Trials for: TAXOTERE

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

Taxotere and Adriamycin/Cytoxan (AC) Validation in Breast Cancer Patients
Status: Recruiting Condition: Breast Cancer

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

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

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

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

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

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

Pharmacokinetic Study of SYP-0704A and Taxotere to Treat Patient With Advanced Solid Cancer
Status: Completed Condition: Solid Tumor

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

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
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-003Aug 3, 2010RXYes<disabled><disabled>
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-005Apr 13, 2012RXYes<disabled><disabled>
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-001May 14, 1996DISCNNo<disabled><disabled>
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Expired Patents for Tradename: TAXOTERE

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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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Paragraph IV activity for: TAXOTERE

Drugname Dosage Strength RLD Submissiondate
docetaxelInjection40 mg/mL, 0.5 mL and 2 mL vialsTaxotere6/30/2009
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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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