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Paclitaxel - Generic Drug Details

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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, Eurohlth Intl Sarl, and Teva Pharms Usa, and is included in fifteen NDAs. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and twenty-six patent family members in twenty-nine countries.

There are sixty-five drug master file entries for paclitaxel. Eleven suppliers are listed for this compound.

Summary for Generic Name: paclitaxel

Tradenames:4
Patents:11
Applicants:14
NDAs:15
Drug Master File Entries: see list65
Suppliers / Packaging: see list11
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: paclitaxel

Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition

Clinical Trials for: paclitaxel

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa
PACLITAXEL
paclitaxel
INJECTABLE;INJECTION075297-001Jan 25, 2002DISCNNo
Hospira
PACLITAXEL
paclitaxel
INJECTABLE;INJECTION076131-001May 8, 2002RXYes
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesSep 6, 2020
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Expired Orange Book Patents for Generic Ingredient: paclitaxel

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 20056,096,331<disabled>
Hq Spclt Pharma
TAXOL
paclitaxel
INJECTABLE;INJECTION020262-001Dec 29, 19925,641,803<disabled>
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 20055,439,686<disabled>
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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
6,096,331 Methods and compositions useful for administration of chemotherapeutic agents<disabled in preview>
5,639,473 Methods for the preparation of nucleic acids for in vivo delivery<disabled in preview>
5,997,904 Total nutrient admixtures as stable multicomponent liquids or dry powders and methods for the preparation thereof<disabled in preview>
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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
Portugal1853250<disabled in preview>
Russian Federation2009110382<disabled in preview>
World Intellectual Property Organization (WIPO)2006089290<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: PACLITAXEL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00673Netherlands<disabled>PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
0673Netherlands<disabled>PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
613Luxembourg<disabled>91613, EXPIRES: 20220924
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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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