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Serving leading biopharmaceutical companies globally:

Fuji
Cerilliant
Healthtrust
Merck
US Department of Justice
Deloitte
Covington
Fish and Richardson
Moodys
Mallinckrodt

Generated: February 21, 2018

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 twelve patents protecting this drug and one Paragraph IV challenge.

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

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

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) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for ABRAXANE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ➤ Sign Up ➤ Sign Up
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ➤ Sign Up ➤ Sign Up
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ➤ Sign Up ➤ Sign Up
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ➤ Sign Up ➤ Sign Up
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ➤ Sign Up ➤ Sign Up
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ➤ Sign Up ➤ Sign Up
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ➤ Sign Up ➤ Sign Up
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for ABRAXANE
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe For Injection Suspension 100 mg/vial ➤ Subscribe 12/11/2015

Non-Orange Book US Patents for 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
5,439,686 Methods for in vivo delivery of substantially water insoluble pharmacologically active agents and compositions useful therefor ➤ Sign Up
7,780,984 Methods and compositions for treating proliferative diseases ➤ Sign Up
5,916,596 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof ➤ Sign Up
9,561,288 Combinations and modes of administration of therapeutic agents and combination therapy ➤ Sign Up
5,650,156 Methods for in vivo delivery of nutriceuticals and compositions useful therefor ➤ Sign Up
5,512,268 Polymeric shells for medical imaging prepared from synthetic polymers, and methods for the use thereof ➤ Sign Up
5,508,021 Non-fluorinated polymeric shells for medical imaging ➤ Sign Up
8,137,684 Formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof ➤ Sign Up
6,537,579 Compositions and methods for administration of pharmacologically active compounds ➤ Sign Up
5,997,904 Total nutrient admixtures as stable multicomponent liquids or dry powders and methods for the preparation thereof ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for ABRAXANE

Supplementary Protection Certificates for ABRAXANE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0961612/01 Switzerland ➤ Sign Up PRODUCT NAME: PACLITAXELUM-ALBUMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63182 26.08.2014
C0050 France ➤ Sign Up PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080111
00673 Netherlands ➤ Sign Up PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
2014 00034 Denmark ➤ Sign Up PRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: C(2013)9835 20131220
613 Luxembourg ➤ Sign Up 91613, EXPIRES: 20220924
41/2009 Austria ➤ Sign Up PRODUCT NAME: PACLITAXEL ALBUMIN
/2014 Austria ➤ Sign Up PRODUCT NAME: PACLITAXEL, DAS ALS ALBUMIN GEBUNDENE NANOPARTIKEL FORMUIERT IST.; REGISTRATION NO/DATE: EU/1/07/428 (MITTEILUNG) (GEAENDERT DURCH C(2013) 9835) 20131230
0673 Netherlands ➤ Sign Up PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
8 50005-2014 Slovakia ➤ Sign Up PRODUCT NAME: PAKLITAXEL VO FORME NANOCASTIC VIAZANYCH NA ALBUMIN; REGISTRATION NO/DATE: EU/1/07/428/001 - EU/1/07/428/002 20131230
2014000065 Germany ➤ Sign Up PRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Covington
Julphar
Dow
Farmers Insurance
Fuji
US Department of Justice
Daiichi Sankyo
Cipla

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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