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Docetaxel - Generic Drug Details

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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 Inc, Pfizer Labs, Teva Pharms Usa, Dr Reddys Labs Ltd, and Accord Hlthcare, and is included in eleven 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 fourteen patent family members in fourteen countries.

There are thirty-nine drug master file entries for docetaxel. Fourteen suppliers are listed for this compound.

Summary for Generic Name: docetaxel

Tradenames:3
Patents:2
Applicants:11
NDAs:11
Drug Master File Entries: see list39
Suppliers / Packaging: see list14
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: docetaxel

Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-003Aug 3, 2010RXYes► subscribe► subscribe
Accord Hlthcare
DOCETAXEL
docetaxel
INJECTABLE;INJECTION201195-001Jun 8, 2011RXNo► subscribe► subscribe
Pfizer Labs
DOCETAXEL
docetaxel
INJECTABLE;INJECTION202356-004Mar 13, 2014RXNo► 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;INJECTION020449-003Aug 3, 20105,750,561*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
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International Patent Family for Ingredient: docetaxel

Country Document Number Estimated Expiration
Singapore11201502352W► subscribe
China104822262► subscribe
Argentina092759► 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
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
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)
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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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