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Last Updated: July 6, 2020

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PACLITAXEL - Generic Drug Details

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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, 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 sixteen 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 thirty-seven patent family members in thirty-one countries.

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

Drug Prices for PACLITAXEL

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Recent Clinical Trials for PACLITAXEL

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

SponsorPhase
Adlai Nortye Biopharma Co., Ltd.Phase 3
Brooklyn ImmunoTherapeutics, LLCPhase 2
Providence Health & ServicesPhase 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
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
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gland Pharma Ltd PACITAXEL paclitaxel INJECTABLE;INJECTION 207326-001 Aug 23, 2016 AP RX 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 Y   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
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
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
>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
0961612 2009C/046 Belgium   Start Trial PRODUCT NAME: PACLITAXEL ALBUMIN; AUTHORISATION NUMBER AND DATE: EU/1/07/428/001 20080111
0961612 C00961612/01 Switzerland   Start Trial PRODUCT NAME: PACLITAXELUM-ALBUMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63182 26.08.2014
1853250 CA 2014 00034 Denmark   Start Trial PRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: EU/1/07/428 C(2013)9835 20131230
1853250 2014C/037 Belgium   Start Trial PRODUCT NAME: PACLITAXEL DANS UNE FORMULATION DE NANOPARTICULE LIEES A L'ALBUMINE; AUTHORISATION NUMBER AND DATE: EU/1/07/428 20131230
1853250 37/2014 Austria   Start Trial PRODUCT NAME: PACLITAXEL, DAS ALS ALBUMIN GEBUNDENE NANOPARTIKEL FORMUIERT IST.; REGISTRATION NO/DATE: EU/1/07/428 (MITTEILUNG) (GEAENDERT DURCH C(2013) 9835) 20131230
1853250 238 50005-2014 Slovakia   Start Trial PRODUCT NAME: PAKLITAXEL VO FORME NANOCASTIC VIAZANYCH NA ALBUMIN; REGISTRATION NO/DATE: EU/1/07/428/001 - EU/1/07/428/002 20131230
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Baxter
McKinsey
Merck
Johnson and Johnson
Dow

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