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Docetaxel - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for docetaxel?

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

This ingredient has fifteen patent family members in fifteen countries.

There are forty drug master file entries for docetaxel. Fourteen suppliers are listed for this compound.

Summary for Generic Name: docetaxel

Tradenames:3
Patents:3
Applicants:13
NDAs:13
Drug Master File Entries: see list40
Suppliers / Packagers: see list14
Bulk Api Vendors: see list59
Clinical Trials: see list667
Patent Applications: see list9,845
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:docetaxel at DailyMed

Pharmacology for Ingredient: docetaxel

Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa
DOCETAXEL
docetaxel
INJECTABLE;INJECTION203877-002Sep 16, 2015RXNoNo► Subscribe► Subscribe
Sun Pharma Global
DOCEFREZ
docetaxel
INJECTABLE;INJECTION022534-002May 3, 2011RXYesYes► Subscribe► Subscribe
Pfizer Labs
DOCETAXEL
docetaxel
INJECTABLE;INJECTION202356-004Mar 13, 2014DISCNNoNo► Subscribe► Subscribe
Dfb Oncology Ltd
DOCETAXEL
docetaxel
INJECTABLE;INJECTION206177-002Jan 20, 2017RXNoNo► Subscribe► Subscribe
Pfizer Labs
DOCETAXEL
docetaxel
INJECTABLE;INJECTION202356-003Mar 13, 2014DISCNNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: docetaxel

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-004Aug 2, 20105,714,512*PED► Subscribe
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-001May 14, 19964,814,470*PED► Subscribe
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-001May 14, 19965,714,512*PED► Subscribe
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-003Aug 3, 20104,814,470*PED► Subscribe
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-001May 14, 19965,750,561*PED► Subscribe
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International Patent Family for Ingredient: docetaxel

Country Document Number Estimated Expiration
Philippines12015500681► Subscribe
Hong Kong1210665► Subscribe
Taiwan201417842► Subscribe
Russian Federation2015116260► Subscribe
China104822262► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: DOCETAXEL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
172Luxembourg► SubscribePRODUCT 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)
60002Netherlands► SubscribePRODUCT NAME: DOCETAXEL, DESGEWENST IN DE VORM VAN EEN TRIHYDRAAT; REGISTRATION NO/DATE: EU/1/95/002/001 - EU/1/95/002/002 19951127
/2013Austria► SubscribePRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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