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Last Updated: August 12, 2020

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DOCETAXEL Drug 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, 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 Sun Pharma Global. and is included in twenty-one NDAs. There are three patents protecting this drug.

This drug has twenty-two patent family members in nineteen countries.

The generic ingredient in DOCETAXEL 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 Docetaxel

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

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Drug patent expirations by year for DOCETAXEL
Drug Prices for DOCETAXEL

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Recent Clinical Trials for DOCETAXEL

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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
Pfizer Labs DOCETAXEL docetaxel INJECTABLE;INJECTION 202356-001 Mar 13, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
Ingenus Pharms Llc DOCETAXEL docetaxel INJECTABLE;INJECTION 207563-003 Aug 31, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Shilpa Medicare Ltd DOCETAXEL docetaxel INJECTABLE;INJECTION 210327-002 May 16, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Teikoku Pharma DOCETAXEL docetaxel INJECTABLE;INJECTION 205934-002 Dec 22, 2015 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

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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