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Last Updated: September 28, 2021

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DOCETAXEL Drug Patent Profile


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When do Docetaxel patents expire, and what generic alternatives are available?

Docetaxel is a drug marketed by Accord Hlthcare, Actavis Llc, Amneal, Apotex Inc, Dfb Oncology Ltd, Dr Reddys Labs Ltd, Eugia Pharma, Gland Pharma Ltd, Hikma, Hong Kong, Hospira Inc, Ingenus Pharms Llc, Jiangsu Hengrui Med, Mylan Labs Ltd, Pfizer Labs, Sandoz, Shilpa, Teva Pharms Usa, and Sun Pharma Global. and is included in twenty-four NDAs. There are four patents protecting this drug.

This drug has fifty-three patent family members in twenty-six countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Docetaxel

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

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Summary for DOCETAXEL
Drug patent expirations by year for DOCETAXEL
Drug Prices for DOCETAXEL

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Recent Clinical Trials for DOCETAXEL

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

SponsorPhase
AbbViePhase 3
Anqin ZhangPhase 2
Coherent Biopharma (Suzhou) Co., Ltd.Phase 1

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
Jiangsu Hengrui Med DOCETAXEL docetaxel INJECTABLE;INJECTION 207252-001 Aug 9, 2017 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hospira Inc DOCETAXEL docetaxel INJECTABLE;INJECTION 022234-004 Jun 23, 2016 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer Labs DOCETAXEL docetaxel INJECTABLE;INJECTION 202356-001 Mar 13, 2014 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan Labs Ltd DOCETAXEL docetaxel INJECTABLE;INJECTION 210072-001 Jul 2, 2018 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for DOCETAXEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1667986 92172 Luxembourg ⤷  Free Forever 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 ⤷  Free Forever Trial PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
0253738 C960002 Netherlands ⤷  Free Forever 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Baxter
Express Scripts
Moodys
Mallinckrodt
AstraZeneca

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