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Serving leading biopharmaceutical companies globally:

Merck
UBS
Covington
Colorcon
Deloitte
Accenture
Boehringer Ingelheim
Citi
Harvard Business School
Argus Health

Generated: December 17, 2017

DrugPatentWatch Database Preview

DOCETAXEL - Generic Drug Details

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What are the generic sources for docetaxel and what is the scope of docetaxel freedom to operate?

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

Docetaxel has fifteen patent family members in fifteen countries and three supplementary protection certificates in three countries.

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

Pharmacology for DOCETAXEL

Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eagle PharmsDOCETAXELdocetaxelSOLUTION;IV (INFUSION)205934-002Dec 22, 2015RXNoNo► Subscribe► SubscribeY► Subscribe
Teva Pharms UsaDOCETAXELdocetaxelINJECTABLE;INJECTION203877-001Sep 16, 2015APRXNoNo► Subscribe► Subscribe► Subscribe
Pfizer LabsDOCETAXELdocetaxelINJECTABLE;INJECTION202356-002Mar 13, 2014DISCNNoNo► Subscribe► Subscribe► Subscribe
Eagle PharmsDOCETAXELdocetaxelSOLUTION;IV (INFUSION)205934-003Dec 22, 2015RXNoNo► Subscribe► SubscribeY► Subscribe
Jiangsu Hengrui MedDOCETAXELdocetaxelINJECTABLE;INJECTION207252-003Aug 9, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Hospira IncDOCETAXELdocetaxelINJECTABLE;INJECTION022234-004Jun 23, 2016RXYesNo► Subscribe► Subscribe► Subscribe
Pfizer LabsDOCETAXELdocetaxelINJECTABLE;INJECTION202356-004Mar 13, 2014DISCNNoNo► Subscribe► Subscribe► Subscribe
Sanofi Aventis UsTAXOTEREdocetaxelINJECTABLE;INJECTION020449-005Apr 13, 2012APRXYesYes► Subscribe► Subscribe► Subscribe
Hospira IncDOCETAXELdocetaxelINJECTABLE;INJECTION022234-007Jan 24, 2017RXYesNo► Subscribe► Subscribe► Subscribe
Hospira IncDOCETAXELdocetaxelINJECTABLE;INJECTION022234-005Jun 23, 2016RXYesNo► Subscribe► 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 UsTAXOTEREdocetaxelINJECTABLE;INJECTION020449-001May 14, 1996► Subscribe► Subscribe
Sanofi Aventis UsTAXOTEREdocetaxelINJECTABLE;INJECTION020449-004Aug 2, 2010► Subscribe► Subscribe
Sanofi Aventis UsTAXOTEREdocetaxelINJECTABLE;INJECTION020449-003Aug 3, 2010► Subscribe► Subscribe
Sanofi Aventis UsTAXOTEREdocetaxelINJECTABLE;INJECTION020449-001May 14, 1996► Subscribe► Subscribe
Sanofi Aventis UsTAXOTEREdocetaxelINJECTABLE;INJECTION020449-004Aug 2, 2010► Subscribe► Subscribe
Sanofi Aventis UsTAXOTEREdocetaxelINJECTABLE;INJECTION020449-001May 14, 1996► Subscribe► Subscribe
Sanofi Aventis UsTAXOTEREdocetaxelINJECTABLE;INJECTION020449-001May 14, 1996► Subscribe► Subscribe
Sanofi Aventis UsTAXOTEREdocetaxelINJECTABLE;INJECTION020449-003Aug 3, 2010► Subscribe► Subscribe
Sanofi Aventis UsTAXOTEREdocetaxelINJECTABLE;INJECTION020449-001May 14, 1996► Subscribe► Subscribe
Sanofi Aventis UsTAXOTEREdocetaxelINJECTABLE;INJECTION020449-001May 14, 1996► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: docetaxel

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,763,880Non-aqueous taxane formulations and methods of using the same► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: docetaxel

Country Document Number Estimated Expiration
Hong Kong1210665► Subscribe
Japan2015534558► Subscribe
China104822262► Subscribe
Singapore11201502352W► Subscribe
European Patent Office2903435► Subscribe
Canada2885930► Subscribe
Australia2013327563► Subscribe
South Korea20150066542► Subscribe
India2661DEN2015► Subscribe
Philippines12015500681► 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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Serving leading biopharmaceutical companies globally:

Chubb
UBS
Merck
Daiichi Sankyo
Novartis
Covington
Deloitte
Harvard Business School
US Department of Justice
Fuji

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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