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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Citi
Fish and Richardson
Covington
Colorcon
AstraZeneca
Boehringer Ingelheim
Express Scripts
Chinese Patent Office
Medtronic

Generated: January 21, 2018

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.

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

US Patents and Regulatory Information for docetaxel

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira Inc DOCETAXEL docetaxel INJECTABLE;INJECTION 022234-004 Jun 23, 2016 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Jiangsu Hengrui Med DOCETAXEL docetaxel INJECTABLE;INJECTION 207252-001 Aug 9, 2017 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apotex Inc DOCETAXEL docetaxel INJECTABLE;INJECTION 022312-002 Jan 11, 2012 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Hospira Inc DOCETAXEL docetaxel INJECTABLE;INJECTION 022234-006 Jun 23, 2016 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Actavis Llc DOCETAXEL docetaxel INJECTABLE;INJECTION 203551-002 Apr 12, 2013 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Jiangsu Hengrui Med DOCETAXEL docetaxel INJECTABLE;INJECTION 203170-001 Feb 15, 2017 RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sun Pharma Global DOCEFREZ docetaxel INJECTABLE;INJECTION 022534-001 May 3, 2011 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Dr Reddys Labs Ltd DOCETAXEL docetaxel INJECTABLE;INJECTION 204193-002 Nov 5, 2014 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-003 Aug 3, 2010 AP RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Dfb Oncology Ltd DOCETAXEL docetaxel INJECTABLE;INJECTION 206177-002 Jan 20, 2017 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for docetaxel

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-001 May 14, 1996 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-003 Aug 3, 2010 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-001 May 14, 1996 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-003 Aug 3, 2010 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-001 May 14, 1996 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-003 Aug 3, 2010 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
9,763,880 Non-aqueous taxane formulations and methods of using the same ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for docetaxel

Supplementary Protection Certificates for docetaxel

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
60002 Netherlands ➤ Subscribe PRODUCT NAME: DOCETAXEL, DESGEWENST IN DE VORM VAN EEN TRIHYDRAAT; REGISTRATION NO/DATE: EU/1/95/002/001 - EU/1/95/002/002 19951127
172 Luxembourg ➤ Subscribe 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)
/2013 Austria ➤ Subscribe PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Fuji
Daiichi Sankyo
Mallinckrodt
Healthtrust
Chubb
Queensland Health
Covington
Merck
Moodys

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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