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Last Updated: May 27, 2022

ABRAXANE Drug Patent Profile


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Which patents cover Abraxane, and what generic alternatives are available?

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

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

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Abraxane

A generic version of ABRAXANE was approved as paclitaxel by TEVA PHARMS on January 25th, 2002.

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Drug patent expirations by year for ABRAXANE
Drug Prices for ABRAXANE

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Recent Clinical Trials for ABRAXANE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Devalingam MahalingamPhase 1/Phase 2
AmgenPhase 1/Phase 2
CSPC Ouyi Pharmaceutical Co., Ltd.Phase 1

See all ABRAXANE clinical trials

Paragraph IV (Patent) Challenges for ABRAXANE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ABRAXANE For Injection Suspension paclitaxel 100 mg/vial 021660 1 2015-12-11

US Patents and Regulatory Information for ABRAXANE

ABRAXANE is protected by eleven US patents and two FDA Regulatory Exclusivities.

Patents protecting ABRAXANE

Combinations and modes of administration of therapeutic agents and combination therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods of delivery of pharmacological agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods of delivery of pharmacological agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Combinations and modes of administration of therapeutic agents and combination therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods of delivery of pharmacological agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Combinations and modes of administration of therapeutic agents and combination therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods of delivery of pharmacological agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Combinations and modes of administration of therapeutic agents and combination therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of treating cancer
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of treating pancreatic cancer
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of treating cancer
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting ABRAXANE

ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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 POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Abraxis Bioscience ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Abraxis Bioscience ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ABRAXANE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abraxis Bioscience ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 See Plans and Pricing See Plans and Pricing
Abraxis Bioscience ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 See Plans and Pricing See Plans and Pricing
Abraxis Bioscience ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ABRAXANE

See the table below for patents covering ABRAXANE around the world.

Country Patent Number Title Estimated Expiration
Japan 5926724 See Plans and Pricing
Japan 2018087235 膵臓がんの処置方法 (METHODS OF TREATING PANCREATIC CANCER) See Plans and Pricing
Japan 2020011999 組成物及び薬物送達方法 (COMPOSITION AND METHOD OF DELIVERY OF PHARMACOLOGICAL AGENT) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ABRAXANE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0961612 300417 Netherlands See Plans and Pricing PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080114
0961612 09C0050 France See Plans and Pricing PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080111
1853250 300673 Netherlands See Plans and Pricing PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Colorcon
Dow
Mallinckrodt
Harvard Business School
Boehringer Ingelheim

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