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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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US Army
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Generated: December 10, 2017

DrugPatentWatch Database Preview

ABRAXANE Drug Profile

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Which patents cover Abraxane, and when can generic versions of Abraxane launch?

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

This drug has two hundred and eighty-five patent family members in thirty-one countries and twelve supplementary protection certificates in nine countries.

The generic ingredient in ABRAXANE is paclitaxel. There are sixty-seven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.
Drug patent expirations by year for ABRAXANE

Pharmacology for ABRAXANE

Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition

Medical Subject Heading (MeSH) Categories for ABRAXANE

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Abraxis BioscienceABRAXANEpaclitaxelFOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Abraxis BioscienceABRAXANEpaclitaxelFOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Abraxis BioscienceABRAXANEpaclitaxelFOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Abraxis BioscienceABRAXANEpaclitaxelFOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Abraxis BioscienceABRAXANEpaclitaxelFOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Abraxis BioscienceABRAXANEpaclitaxelFOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Abraxis BioscienceABRAXANEpaclitaxelFOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Abraxis BioscienceABRAXANEpaclitaxelFOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Abraxis BioscienceABRAXANEpaclitaxelFOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Abraxis BioscienceABRAXANEpaclitaxelFOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: ABRAXANE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abraxis BioscienceABRAXANEpaclitaxelFOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005► Subscribe► Subscribe
Abraxis BioscienceABRAXANEpaclitaxelFOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005► Subscribe► Subscribe
Abraxis BioscienceABRAXANEpaclitaxelFOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005► Subscribe► Subscribe
Abraxis BioscienceABRAXANEpaclitaxelFOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005► Subscribe► Subscribe
Abraxis BioscienceABRAXANEpaclitaxelFOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005► Subscribe► Subscribe
Abraxis BioscienceABRAXANEpaclitaxelFOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005► Subscribe► Subscribe
Abraxis BioscienceABRAXANEpaclitaxelFOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005► Subscribe► Subscribe
Abraxis BioscienceABRAXANEpaclitaxelFOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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► Subscribe
6,096,331 Methods and compositions useful for administration of chemotherapeutic agents► Subscribe
5,498,421 Composition useful for in vivo delivery of biologics and methods employing same► Subscribe
5,665,382 Methods for the preparation of pharmaceutically active agents for in vivo delivery► Subscribe
5,362,478 Magnetic resonance imaging with fluorocarbons encapsulated in a cross-linked polymeric shell► Subscribe
7,780,984Methods and compositions for treating proliferative diseases► Subscribe
6,528,067 Total nutrient admixtures as stable multicomponent liquids or dry powders and methods for the preparation thereof► Subscribe
5,916,596 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof► Subscribe
5,505,932 Method for the preparation of fluorocarbon-containing polymeric shells for medical imaging► Subscribe
5,512,268 Polymeric shells for medical imaging prepared from synthetic polymers, and methods for the use 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
China103285395► Subscribe
China100462066► Subscribe
Australia7117196► Subscribe
Russian Federation2009110382► Subscribe
Hong Kong1024866► Subscribe
BrazilPI9711856► Subscribe
Singapore165156► Subscribe
Canada2897589► Subscribe
Japan2015155454► Subscribe
Denmark1853250► 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
2014022Lithuania► SubscribePRODUCT NAME: PACLITAXELUM; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
41/2009Austria► SubscribePRODUCT NAME: PACLITAXEL ALBUMIN
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
00673Netherlands► SubscribePRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
2014 00034Denmark► SubscribePRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: C(2013)9835 20131220
1Finland► Subscribe
613Luxembourg► Subscribe91613, EXPIRES: 20220924
2014000065Germany► SubscribePRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220
/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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
US Department of Justice
Express Scripts
Novartis
Accenture
UBS
Cerilliant
Moodys
QuintilesIMS
McKesson

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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