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Last Updated: March 28, 2024

ABRAXANE Drug Patent Profile


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

Abraxane is a drug marketed by Bristol-myers 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. Eighteen 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

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SponsorPhase
Aarhus University HospitalPhase 2
Morten LadekarlPhase 2
Fujian Medical University Union HospitalPhase 2

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Pharmacology for ABRAXANE
Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition
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.

Patents protecting ABRAXANE

Combinations and modes of administration of therapeutic agents and combination therapy
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Patent Expiration: ⤷  Try a Trial

Compositions and methods of delivery of pharmacological agents
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Compositions and methods of delivery of pharmacological agents
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Combinations and modes of administration of therapeutic agents and combination therapy
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Compositions and methods of delivery of pharmacological agents
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Combinations and modes of administration of therapeutic agents and combination therapy
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Patent Expiration: ⤷  Try a Trial

Compositions and methods of delivery of pharmacological agents
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Combinations and modes of administration of therapeutic agents and combination therapy
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Methods of treating cancer
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Methods of treating pancreatic cancer
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Methods of treating cancer
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Patent Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol-myers ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bristol-myers ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bristol-myers ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Bristol-myers ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 ⤷  Try a Trial ⤷  Try a Trial
Bristol-myers ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 ⤷  Try a Trial ⤷  Try a Trial
Bristol-myers ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ABRAXANE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Bristol-Myers Squibb Pharma EEIG Abraxane paclitaxel EMEA/H/C/000778
Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated.Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
Authorised no no no 2008-01-11
ratiopharm GmbH Pazenir paclitaxel EMEA/H/C/004441
Pazenir monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated.Pazenir in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
Authorised yes no no 2019-05-06
Inceptua AB Apealea paclitaxel EMEA/H/C/004154
Apealea in combination with carboplatin is indicated for the treatment of adult patients with first relapse of platinum‑sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.
Authorised no no no 2018-11-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ABRAXANE

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

Country Patent Number Title Estimated Expiration
Hong Kong 1173976 紫杉醇和白蛋白納米顆粒聯合貝伐單抗對抗癌症 (NANOPARTICLES OF PACLITAXEL AND ALBUMIN IN COMBINATION WITH BEVACIZUMAB AGAINST CANCER) ⤷  Try a Trial
Canada 2446083 COMPOSITION ET PROCEDES DE TRAITEMENT D'HYPERPLASIE (COMPOSITION AND METHODS FOR TREATMENT OF HYPERPLASIA) ⤷  Try a Trial
European Patent Office 2272504 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ABRAXANE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1853250 C300673 Netherlands ⤷  Try a Trial PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
0961612 09C0050 France ⤷  Try a Trial PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080111
0961612 91613 Luxembourg ⤷  Try a Trial 91613, EXPIRES: 20220924
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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