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Generated: November 19, 2017

DrugPatentWatch Database Preview

PACLITAXEL - Generic Drug Details

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

Paclitaxel
is the generic ingredient in four branded drugs marketed by Pliva Lachema, Gland Pharma Ltd, Actavis Totowa, Hospira, Accord Hlthcare, Mylan Labs Ltd, Abraxis Bioscience, Hq Spclt Pharma, Sandoz Inc, Fresenius Kabi Oncol, Mylan, Teva Pharms, West-ward Pharms Int, and Teva Pharms Usa, and is included in fifteen NDAs. There are thirteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Paclitaxel has two hundred and eighty-four patent family members in thirty-one countries and twelve supplementary protection certificates in nine countries.

There are sixty-seven drug master file entries for paclitaxel. Thirteen suppliers are listed for this compound.

Pharmacology for PACLITAXEL

Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition

Medical Subject Heading (MeSH) Categories for PACLITAXEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► Subscribe ► Subscribe
Hospira
PACLITAXEL
paclitaxel
INJECTABLE;INJECTION076131-001May 8, 2002APRXNoYes► Subscribe► Subscribe► Subscribe
Sandoz Inc
PACLITAXEL
paclitaxel
INJECTABLE;INJECTION078167-001Dec 26, 2007APRXNoNo► Subscribe► Subscribe► Subscribe
Gland Pharma Ltd
PACITAXEL
paclitaxel
INJECTABLE;INJECTION207326-001Aug 23, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Accord Hlthcare
PACLITAXEL
paclitaxel
INJECTABLE;INJECTION075436-001Nov 12, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► Subscribe ► Subscribe
Mylan Labs Ltd
PACLITAXEL
paclitaxel
INJECTABLE;INJECTION091540-001Sep 29, 2011APRXNoNo► Subscribe► Subscribe► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► Subscribe► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► Subscribe ► Subscribe
Fresenius Kabi Oncol
PACLITAXEL
paclitaxel
INJECTABLE;INJECTION077574-001Nov 27, 2006APRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: paclitaxel

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005► Subscribe► Subscribe
Hq Spclt Pharma
TAXOL
paclitaxel
INJECTABLE;INJECTION020262-001Dec 29, 1992► Subscribe► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005► Subscribe► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005► Subscribe► Subscribe
Hq Spclt Pharma
TAXOL
paclitaxel
INJECTABLE;INJECTION020262-001Dec 29, 1992► Subscribe► Subscribe
Hq Spclt Pharma
TAXOL
paclitaxel
INJECTABLE;INJECTION020262-001Dec 29, 1992► Subscribe► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005► Subscribe► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005► Subscribe► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005► Subscribe► Subscribe
Hq Spclt Pharma
TAXOL
paclitaxel
INJECTABLE;INJECTION020262-001Dec 29, 1992► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: paclitaxel

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
7,780,984Methods and compositions for treating proliferative diseases► Subscribe
6,528,067 Total nutrient admixtures as stable multicomponent liquids or dry powders and methods for the preparation thereof► Subscribe
5,505,932 Method for the preparation of fluorocarbon-containing polymeric shells for medical imaging► Subscribe
5,834,025 Reduction of intravenously administered nanoparticulate-formulation-induced adverse physiological reactions► Subscribe
5,665,383 Methods for the preparation of immunostimulating agents for in vivo delivery► Subscribe
5,635,207 Methods for the preparation of blood substitutes for in vivo delivery► Subscribe
5,439,686 Methods for in vivo delivery of substantially water insoluble pharmacologically active agents and compositions useful therefor► Subscribe
5,916,596 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof► Subscribe
8,846,771Compositions and methods of delivery of pharmacological agents► Subscribe
8,137,684Formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof► 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: paclitaxel

Country Document Number Estimated Expiration
Australia784416► Subscribe
Japan2014224157► Subscribe
Japan2015147817► Subscribe
China102343094► Subscribe
Mexico337149► Subscribe
Netherlands300417► Subscribe
Denmark1023050► Subscribe
European Patent Office1178786► Subscribe
South Africa200707491► Subscribe
Canada2267498► 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: PACLITAXEL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014000065Germany► SubscribePRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220
41/2009Austria► SubscribePRODUCT NAME: PACLITAXEL ALBUMIN
613Luxembourg► Subscribe91613, EXPIRES: 20220924
2014 00034Denmark► SubscribePRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: C(2013)9835 20131220
8 50005-2014Slovakia► SubscribePRODUCT NAME: PAKLITAXEL VO FORME NANOCASTIC VIAZANYCH NA ALBUMIN; REGISTRATION NO/DATE: EU/1/07/428/001 - EU/1/07/428/002 20131230
/2014Austria► SubscribePRODUCT NAME: PACLITAXEL, DAS ALS ALBUMIN GEBUNDENE NANOPARTIKEL FORMUIERT IST.; REGISTRATION NO/DATE: EU/1/07/428 (MITTEILUNG) (GEAENDERT DURCH C(2013) 9835) 20131230
2014022Lithuania► SubscribePRODUCT NAME: PACLITAXELUM; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
0673Netherlands► SubscribePRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
C0050France► SubscribePRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE IN FRANCE: EU/1/07/428/001 DU 20080111; REGISTRATION NO/DATE AT EEC: EU/1/07/428/001 DU 20080111
1Finland► Subscribe
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Serving leading biopharmaceutical companies globally:

Dow
Merck
AstraZeneca
Baxter
Citi
Cantor Fitzgerald
McKinsey
Queensland Health
Teva
Novartis

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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