➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Express Scripts
Medtronic
Dow
Mallinckrodt
Colorcon
McKinsey

Last Updated: January 18, 2021

DrugPatentWatch Database Preview

Paclitaxel - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

What are the generic sources for paclitaxel and what is the scope of freedom to operate?

Paclitaxel is the generic ingredient in four branded drugs marketed by Abraxis Bioscience, Gland Pharma Ltd, Accord Hlthcare, Actavis Totowa, Fresenius Kabi Usa, Hospira, MSN, Mylan, Mylan Labs Ltd, Pliva Lachema, Sandoz Inc, Teva Pharms, Teva Pharms Usa, West-ward Pharms Int, and Hq Spclt Pharma, and is included in seventeen NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Paclitaxel has three hundred and fifty-one patent family members in thirty-one countries.

There are sixty-nine drug master file entries for paclitaxel. Eleven suppliers are listed for this compound.

Drug Prices for paclitaxel

See drug prices for paclitaxel

Recent Clinical Trials for paclitaxel

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

SponsorPhase
CSPC-NBP Pharmaceutical Co., Ltd.Phase 2
Conjupro Biotherapeutics, Inc.Phase 2
IpsenPhase 2

See all paclitaxel clinical trials

Pharmacology for paclitaxel
Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition
Medical Subject Heading (MeSH) Categories for paclitaxel
Paragraph IV (Patent) Challenges for PACLITAXEL
Tradename Dosage Ingredient NDA Submissiondate
ABRAXANE FOR SUSPENSION;IV (INFUSION) paclitaxel 021660 2015-12-11
TAXOL INJECTABLE;INJECTION paclitaxel 020262

US Patents and Regulatory Information for paclitaxel

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pliva Lachema PACLITAXEL paclitaxel INJECTABLE;INJECTION 077413-001 Mar 12, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Msn PACLITAXEL paclitaxel INJECTABLE;INJECTION 213434-001 Aug 24, 2020 AP RX No No   Start Trial   Start Trial   Start Trial
Mylan PACLITAXEL paclitaxel INJECTABLE;INJECTION 075278-001 Jan 25, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes   Start Trial   Start Trial   Start Trial
Accord Hlthcare PACLITAXEL paclitaxel INJECTABLE;INJECTION 205720-001 Aug 17, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes   Start Trial   Start Trial   Start Trial
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes   Start Trial   Start Trial Y   Start 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 paclitaxel

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   Start Trial   Start Trial
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005   Start Trial   Start Trial
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992   Start Trial   Start Trial
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005   Start Trial   Start Trial
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992   Start Trial   Start Trial
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992   Start Trial   Start Trial
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for paclitaxel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1853250 122014000065 Germany   Start Trial PRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220
0961612 2009C/046 Belgium   Start Trial PRODUCT NAME: PACLITAXEL ALBUMIN; AUTHORISATION NUMBER AND DATE: EU/1/07/428/001 20080111
0961612 09C0050 France   Start Trial PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080111
1853250 132014902271575 Italy   Start Trial PRODUCT NAME: PACLITAXEL LEGATO ALL'ALBUMINA FORMULATO IN NANOPARTICELLE(ABRAXANE); AUTHORISATION NUMBER(S) AND DATE(S): EU/01/07/428, 20131220
0961612 132009901771196 Italy   Start Trial PRODUCT NAME: PACLITAXEL(ABRAXANE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/07/428/001, 20080114
0961612 C00961612/01 Switzerland   Start Trial PRODUCT NAME: PACLITAXELUM-ALBUMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63182 26.08.2014
0961612 CA 2009 00036 Denmark   Start Trial PRODUCT NAME: PACLITAXELALBUMIN
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
AstraZeneca
Baxter
Express Scripts
Moodys
Dow

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 verification 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.