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ABRAXANE Drug Profile

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Which patents cover Abraxane, and what substitute generic drugs are available?

Abraxane is a drug marketed by Abraxis Bioscience and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and forty-four patent family members in thirty-one countries.

The generic ingredient in ABRAXANE is paclitaxel. There are sixty-seven 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:12
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list52
Clinical Trials: see list196
Patent Applications: see list7,218
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ABRAXANE at DailyMed

Pharmacology for Tradename: ABRAXANE

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, 2005RXYesYes7,923,536► Subscribe ► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes8,314,156► Subscribe ► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes8,138,229► SubscribeY ► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYesRE41884► Subscribe ► Subscribe
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Expired Patents for Tradename: ABRAXANE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 20056,749,868► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 20055,439,686► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 20056,537,579► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RE41884► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 20056,096,331► Subscribe
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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
6,749,868 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof► Subscribe
5,665,382 Methods for the preparation of pharmaceutically active agents for in vivo delivery► Subscribe
7,780,984Methods and compositions for treating proliferative diseases► Subscribe
5,439,686 Methods for in vivo delivery of substantially water insoluble pharmacologically active agents and compositions useful therefor► Subscribe
6,753,006 Paclitaxel-containing formulations► 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 Tradename: ABRAXANE

Country Document Number Estimated Expiration
Singapore113402► Subscribe
Norway20092179► Subscribe
Japan4837809► Subscribe
BrazilPI0718528► Subscribe
China1157185► 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: ABRAXANE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0673Netherlands► SubscribePRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
00673Netherlands► 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
2009 00036Denmark► Subscribe
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
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