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Serving leading biopharmaceutical companies globally:

Julphar
Johnson and Johnson
US Army
Novartis
Chubb
Harvard Business School
Federal Trade Commission
Mallinckrodt
Cerilliant
Baxter

Generated: October 22, 2017

DrugPatentWatch Database Preview

DOCETAXEL Drug Profile

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What is the patent landscape for Docetaxel, and what generic Docetaxel alternatives are available?

Docetaxel is a drug marketed by Apotex Inc, Sandoz, Hospira Inc, Eagle Pharms, Actavis Llc, Jiangsu Hengrui Med, Pfizer Labs, Ingenus Pharms Llc, 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 drug.

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

The generic ingredient in DOCETAXEL is docetaxel. There are forty drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the docetaxel profile page.

Summary for Tradename: DOCETAXEL

US Patents:2
Applicants:12
NDAs:13
Suppliers / Packagers: see list13
Bulk Api Vendors: see list59
Clinical Trials: see list1,827
Patent Applications: see list9,784
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:DOCETAXEL at DailyMed

Pharmacology for Tradename: 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
Accord Hlthcare
DOCETAXEL
docetaxel
INJECTABLE;INJECTION201195-003Apr 20, 2012APRXYesNo► Subscribe► Subscribe► Subscribe
Jiangsu Hengrui Med
DOCETAXEL
docetaxel
INJECTABLE;INJECTION203170-001Feb 15, 2017RXNoYes► Subscribe► Subscribe► Subscribe
Pfizer Labs
DOCETAXEL
docetaxel
INJECTABLE;INJECTION202356-004Mar 13, 2014DISCNNoNo► Subscribe► Subscribe► Subscribe
Dfb Oncology Ltd
DOCETAXEL
docetaxel
INJECTABLE;INJECTION206177-001Jan 20, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Ingenus Pharms Llc
DOCETAXEL
docetaxel
INJECTABLE;INJECTION207563-001Aug 31, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
DOCETAXEL
docetaxel
INJECTABLE;INJECTION022312-001Jan 11, 2012DISCNNoNo► Subscribe► Subscribe► Subscribe
Eagle Pharms
DOCETAXEL
docetaxel
SOLUTION;IV (INFUSION)205934-003Dec 22, 2015RXNoNo► Subscribe► SubscribeY ► Subscribe
Jiangsu Hengrui Med
DOCETAXEL
docetaxel
INJECTABLE;INJECTION207252-003Aug 9, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Ltd
DOCETAXEL
docetaxel
INJECTABLE;INJECTION204193-002Nov 5, 2014APRXNoNo► Subscribe► Subscribe► Subscribe
Hospira Inc
DOCETAXEL
docetaxel
INJECTABLE;INJECTION022234-004Jun 23, 2016RXYesNo► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: 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 Tradename: DOCETAXEL

Country Document Number Estimated Expiration
Japan2015534558► Subscribe
Canada2885930► Subscribe
India2661DEN2015► Subscribe
Australia2013327563► Subscribe
China104822262► Subscribe
Philippines12015500681► Subscribe
Mexico2015003824► Subscribe
Singapore11201502352W► Subscribe
Hong Kong1210665► 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
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)
/2013Austria► SubscribePRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

US Army
Baxter
Healthtrust
QuintilesIMS
Julphar
Chinese Patent Office
Argus Health
Farmers Insurance
Queensland Health
Accenture

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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