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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

Clinical Trials for: docetaxel

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharma Global
DOCEFREZ
docetaxel
INJECTABLE;INJECTION022534-001May 3, 2011RXYes
Eagle Pharms
DOCETAXEL
docetaxel
SOLUTION;IV (INFUSION)205934-002Dec 22, 2015RXNo9,308,195Sep 30, 2033Y
Hospira Inc
DOCETAXEL
docetaxel
INJECTABLE;INJECTION022234-006Jun 23, 2016RXNo
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Expired Orange Book Patents for Generic Ingredient: docetaxel

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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<disabled>
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-003Aug 3, 20105,714,512*PED<disabled>
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-001May 14, 19964,814,470*PED<disabled>
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International Patent Family for Ingredient: docetaxel

Country Document Number Estimated Expiration
India2661DEN2015<disabled in preview>
Australia2013327563<disabled in preview>
China104822262<disabled in preview>
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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<disabled>PRODUCT NAME: DOCETAXEL, DESGEWENST IN DE VORM VAN EEN TRIHYDRAAT; REGISTRATION NO/DATE: EU/1/95/002/001 - EU/1/95/002/002 19951127
/2013Austria<disabled>PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
172Luxembourg<disabled>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)
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