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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. There is one patent protecting this drug and one Paragraph IV challenge.

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

Summary for Tradename: TAXOTERE

Patents:1
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

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

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

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

Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in HER-2 Positive Breast Cancer
Status: Completed Condition: Breast Cancer

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

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

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
See more clinical trials for this drug
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;INJECTION020449Apr 13, 2012RXYes<disabled><disabled>
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449Aug 3, 2010RXYes<disabled><disabled>
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449Aug 2, 2010RXYes<disabled><disabled>
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449May 14, 1996DISCNNo<disabled><disabled>
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449May 14, 1996DISCNNo5,438,072*PED<disabled>Y<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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