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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, West-ward Pharms Int, and Teva Pharms Usa, and is included in fifteen NDAs. There are twelve 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 forty patent family members in thirty countries.

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

Summary for Generic Name: paclitaxel

Tradenames:4
Patents:12
Applicants:14
NDAs:15
Drug Master File Entries: see list67
Suppliers / Packagers: see list11
Bulk Api Vendors: see list112
Clinical Trials: see list997
Patent Applications: see list48,869
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:paclitaxel at DailyMed

Pharmacology for Ingredient: paclitaxel

Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition
Applicant Tradename Generic Name Dosage NDA Approval Date 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
Hospira
PACLITAXEL
paclitaxel
INJECTABLE;INJECTION076233-001Aug 1, 2002DISCNNoNo► subscribe► subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes9,511,046► 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
Hq Spclt Pharma
TAXOL
paclitaxel
INJECTABLE;INJECTION020262-001Dec 29, 19925,496,804► subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 20055,498,421► subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 20055,439,686► 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
5,362,478 Magnetic resonance imaging with fluorocarbons encapsulated in a cross-linked polymeric shell► subscribe
5,834,025 Reduction of intravenously administered nanoparticulate-formulation-induced adverse physiological reactions► subscribe
5,639,473 Methods for the preparation of nucleic acids for in vivo delivery► 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
Spain2469716► subscribe
Hong Kong1030543► subscribe
Canada2765222► 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
2014 00034Denmark► subscribePRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: C(2013)9835 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
/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
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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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