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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: see list2

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

Extension Neoadjuvant Taxotere: Study of the Effects of Taxotere in Patients With Breast Cancer
Status: Terminated Condition: Breast 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

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

TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer
Status: Recruiting Condition: Carcinoma, Non Small Cell Lung

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

Courtesy of ClinicalTrials.org
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Glossary
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;INJECTION020449-004Aug 2, 2010RXYes<disabled><disabled>
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-005Apr 13, 2012RXYes<disabled><disabled>
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-003Aug 3, 2010RXYes<disabled><disabled>
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-001May 14, 1996DISCNNo<disabled><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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Preferred citation:

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

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