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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 twelve patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and forty-one patent family members in thirty 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
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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, 20055,498,421► 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, 20056,749,868► 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
5,498,421 Composition useful for in vivo delivery of biologics and methods employing same► subscribe
7,780,984Methods and compositions for treating proliferative diseases► subscribe
5,997,904 Total nutrient admixtures as stable multicomponent liquids or dry powders and methods for the preparation 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 Tradename: ABRAXANE

Country Document Number Estimated Expiration
Japan2009185042► subscribe
Japan3746293► subscribe
Australia2007317859► 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
/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
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
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