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Generated: September 25, 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 sixty-three 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. Thirteen suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.

Summary for Tradename: ABRAXANE

Patents:13
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list52
Clinical Trials: see list273
Patent Applications: see list9,499
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 TE 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 ► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► SubscribeY ► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► SubscribeY ► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► Subscribe ► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► Subscribe ► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► SubscribeY ► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► Subscribe ► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► Subscribe ► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► Subscribe► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► 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 Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005► Subscribe► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005► Subscribe► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005► Subscribe► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005► Subscribe► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005► Subscribe► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005► Subscribe► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005► Subscribe► Subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR 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
6,537,579 Compositions and methods for administration of pharmacologically active compounds► Subscribe
6,749,868 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof► Subscribe
5,635,207 Methods for the preparation of blood substitutes for in vivo delivery► Subscribe
7,780,984Methods and compositions for treating proliferative diseases► Subscribe
5,498,421 Composition useful for in vivo delivery of biologics and methods employing same► Subscribe
5,508,021 Non-fluorinated polymeric shells for medical imaging► Subscribe
5,834,025 Reduction of intravenously administered nanoparticulate-formulation-induced adverse physiological reactions► Subscribe
9,012,519Compositions and methods of delivery of pharmacological agents► Subscribe
6,753,006 Paclitaxel-containing formulations► Subscribe
5,560,933 Methods for in vivo delivery of substantially water insoluble pharmacologically active agents and compositions useful therefor► 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
Russian Federation2005121569► Subscribe
South Korea20140016402► Subscribe
Portugal2097078► Subscribe
European Patent Office1585548► Subscribe
Norway20092179► Subscribe
Brazil0210056► Subscribe
Australia2016202000► Subscribe
China1245156► Subscribe
Australia2009217409► Subscribe
Australia2003229084► 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
41/2009Austria► SubscribePRODUCT NAME: PACLITAXEL ALBUMIN
2014000065Germany► SubscribePRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220
2014022Lithuania► SubscribePRODUCT NAME: PACLITAXELUM; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
613Luxembourg► Subscribe91613, EXPIRES: 20220924
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
1Finland► Subscribe
2014 00034Denmark► SubscribePRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: C(2013)9835 20131220
00673Netherlands► SubscribePRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
2009 00036Denmark► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Novartis
UBS
Cantor Fitzgerald
US Army
Chinese Patent Office
Mallinckrodt
Healthtrust
Medtronic
Johnson and Johnson

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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