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Last Updated: August 12, 2020

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DOCETAXEL - Generic Drug Details

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What are the generic drug sources for docetaxel and what is the scope of freedom to operate?

Docetaxel is the generic ingredient in three branded drugs marketed by Sun Pharma Global, Accord Hlthcare, Actavis Llc, Amneal, Apotex Inc, Cipla, Dfb Oncology Ltd, Dr Reddys Labs Ltd, Hospira Inc, Ingenus Pharms Llc, Jiangsu Hengrui Med, Mylan Labs Ltd, Pfizer Labs, Sandoz, Shilpa Medicare Ltd, Teikoku Pharma, Teva Pharms Usa, and Sanofi Aventis Us, and is included in twenty-two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Docetaxel has twenty-two patent family members in nineteen countries.

There are forty-one drug master file entries for docetaxel. Fifteen suppliers are listed for this compound.

Drug Prices for DOCETAXEL

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Recent Clinical Trials for DOCETAXEL

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

SponsorPhase
Alethia BiotherapeuticsPhase 2
NextCure, Inc.Phase 1/Phase 2
Ananda Hemp, Inc.Phase 2

See all DOCETAXEL clinical trials

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

US Patents and Regulatory Information for DOCETAXEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dfb Oncology Ltd DOCETAXEL docetaxel INJECTABLE;INJECTION 206177-003 Jan 20, 2017 RX No No   Start Trial   Start Trial   Start Trial
Pfizer Labs DOCETAXEL docetaxel INJECTABLE;INJECTION 202356-003 Mar 13, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
Cipla DOCETAXEL docetaxel INJECTABLE;INJECTION 209634-001 Aug 24, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare DOCETAXEL docetaxel INJECTABLE;INJECTION 201195-004 Apr 20, 2012 AP RX Yes No   Start Trial   Start Trial   Start Trial
Sun Pharma Global DOCETAXEL docetaxel SOLUTION;INTRAVENOUS 022534-003 Jan 8, 2019 AP RX No No   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 DOCETAXEL

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

Supplementary Protection Certificates for DOCETAXEL

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
1667986 28/2013 Austria   Start Trial PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
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)
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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