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Last Updated: July 23, 2021

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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, Dfb Oncology Ltd, Dr Reddys Labs Ltd, Hikma, Hong Kong, Hospira Inc, Ingenus Pharms Llc, Jiangsu Hengrui Med, Mylan Labs Ltd, Pfizer Labs, Sandoz, Shilpa, Teva Pharms Usa, and Sanofi Aventis Us, and is included in twenty-three NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Docetaxel has fifty-two patent family members in twenty-five countries.

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

Summary for DOCETAXEL
Drug Prices for DOCETAXEL

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Recent Clinical Trials for DOCETAXEL

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

SponsorPhase
Actuate Therapeutics Inc.Phase 2
Brown UniversityPhase 2
Jiangsu Alphamab Biopharmaceuticals Co., LtdPhase 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
Ingenus Pharms Llc DOCETAXEL docetaxel INJECTABLE;INJECTION 207563-001 Aug 31, 2017 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amneal DOCETAXEL docetaxel INJECTABLE;INJECTION 209640-002 Jan 19, 2018 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sun Pharma Global DOCETAXEL docetaxel SOLUTION;INTRAVENOUS 022534-004 Jan 8, 2019 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Shilpa DOCETAXEL docetaxel INJECTABLE;INJECTION 205934-003 Dec 22, 2015 AP RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-005 Apr 13, 2012 AP RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan Labs Ltd DOCETAXEL docetaxel INJECTABLE;INJECTION 210848-001 Jul 6, 2018 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Hospira Inc DOCETAXEL docetaxel INJECTABLE;INJECTION 022234-002 Mar 8, 2011 AP RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 020449-004 Aug 2, 2010 ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-001 May 14, 1996 ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-001 May 14, 1996 ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-003 Aug 3, 2010 ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-001 May 14, 1996 ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010 ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-003 Aug 3, 2010 ⤷  Try it Free ⤷  Try it Free
>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
1667986 92172 Luxembourg ⤷  Try it Free 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 ⤷  Try it Free PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
0253738 C960002 Netherlands ⤷  Try it Free PRODUCT NAME: DOCETAXEL, DESGEWENST IN DE VORM VAN EEN TRIHYDRAAT; REGISTRATION NO/DATE: EU/1/95/002/001 - EU/1/95/002/002 19951127
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
McKesson
Colorcon
Mallinckrodt
Merck

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