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ABRAXANE Drug Profile

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Abraxane is a drug marketed by Abraxis Bioscience and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and five patent family members in twenty-seven countries.

The generic ingredient in ABRAXANE is paclitaxel. There are sixty-five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.

Summary for Tradename: ABRAXANE

Patents:10
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: ABRAXANE

Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition

Clinical Trials for: ABRAXANE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYes7,923,536<disabled> <disabled>
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYes<disabled><disabled>
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYes8,314,156<disabled> <disabled>
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Expired Patents for Tradename: ABRAXANE

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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, 20055,439,686<disabled>
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 20056,537,579<disabled>
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RE41884<disabled>
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Paragraph IV activity for: ABRAXANE

Drugname Dosage Strength RLD Submissiondate
paclitaxel protein-bound particlesFor Injection Suspension100 mg/vialAbraxane12/11/2015

Non-Orange Book Patents for Tradename: ABRAXANE

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
5,508,021 Non-fluorinated polymeric shells for medical imaging<disabled in preview>
5,650,156 Methods for in vivo delivery of nutriceuticals and compositions useful therefor<disabled in preview>
5,439,686 Methods for in vivo delivery of substantially water insoluble pharmacologically active agents and compositions useful therefor<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 Tradename: ABRAXANE

Country Document Number Estimated Expiration
Brazil0317134<disabled in preview>
Australia2007317859<disabled in preview>
Australia2003299590<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: ABRAXANE

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
613Luxembourg<disabled>91613, EXPIRES: 20220924
C0050France<disabled>PRODUCT 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
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