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Last Updated: August 5, 2020

DrugPatentWatch Database Preview

TAXOTERE Drug Profile

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Which patents cover Taxotere, and what generic alternatives are available?

Taxotere is a drug marketed by Sanofi Aventis Us and is included in one NDA.

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

US ANDA Litigation and Generic Entry Outlook for Taxotere

A generic version of TAXOTERE was approved as docetaxel by HOSPIRA INC on March 8th, 2011.

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Drug patent expirations by year for TAXOTERE
Drug Prices for TAXOTERE

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Recent Clinical Trials for TAXOTERE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
RemeGenPhase 3
University of ChicagoPhase 1
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsPhase 2

See all TAXOTERE clinical trials

Pharmacology for TAXOTERE
Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition
Paragraph IV (Patent) Challenges for TAXOTERE
Tradename Dosage Ingredient NDA Submissiondate
TAXOTERE INJECTABLE;INJECTION docetaxel 020449 2009-06-30

US Patents and Regulatory Information for TAXOTERE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-003 Aug 3, 2010 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-005 Apr 13, 2012 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-001 May 14, 1996 DISCN Yes No   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TAXOTERE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010   Start Trial   Start Trial
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010   Start Trial   Start Trial
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-001 May 14, 1996   Start Trial   Start Trial
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-003 Aug 3, 2010   Start Trial   Start Trial
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010   Start Trial   Start Trial
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-003 Aug 3, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for TAXOTERE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0253738 C960002 Netherlands   Start Trial PRODUCT NAME: DOCETAXEL, DESGEWENST IN DE VORM VAN EEN TRIHYDRAAT; REGISTRATION NO/DATE: EU/1/95/002/001 - EU/1/95/002/002 19951127
0253738 96C0009 Belgium   Start Trial PRODUCT NAME: CONCENTRE A 85 % D'OMEGA POLYINSATURES; QUANTITE CORRESPONDANT A :; ESTERS ETHYLIQUES D'ACIDE EICOSAPENTAENOIQUE (EPA) ET D'ACIDE DOCOSAHEXAENOIQUE (DHA); ALPHA TOCOPHEROL; NAT. REGISTRATION NO/DATE: NL 20819 19951002; FIRST REGISTRATION:
1667986 92172 Luxembourg   Start Trial PRODUCT NAME: SOLVAT ACETONIQUE DU CABAZITAXEL, OU DESIGNE SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL OU SOLVAT ACETONIQUE DU (2R,3S)-3-TERT-BUTOXYCARBONYLAMINO-2-HYDROXY-3-PHENYLPROPIONATE DE 4-ACETOXY-2A-BENZOYLOXY-5BETA,20-EPOXY-1-HYDROXY-7BETA,10A-DIMETHOXY-9-OXO-TAX-11-ENE-13A-YLE(ACETONATE DU CABAZITAXEL)
1667986 28/2013 Austria   Start Trial PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
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Baxter
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McKesson
Colorcon

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