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Last Updated: July 23, 2021

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Paclitaxel - Generic Drug Details

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What are the generic drug 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-three patent family members in thirty-one countries.

There are sixty-nine drug master file entries for paclitaxel. Five suppliers are listed for this compound. There is one tentative approval 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
Jonathan Schoenfeld, MD, MPHPhase 2
NOXXON Pharma AGPhase 2
NaverisPhase 2

See all paclitaxel clinical trials

Generic filers with tentative approvals for PACLITAXEL
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free100MG/VIALFOR SUSPENSION;IV (INFUSION)

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Teva Pharms Usa PACLITAXEL paclitaxel INJECTABLE;INJECTION 075297-001 Jan 25, 2002 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Actavis Totowa PACLITAXEL paclitaxel INJECTABLE;INJECTION 090130-001 Dec 9, 2009 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Hospira PACLITAXEL paclitaxel INJECTABLE;INJECTION 076131-001 May 8, 2002 AP RX No Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan Labs Ltd PACLITAXEL paclitaxel INJECTABLE;INJECTION 091540-001 Sep 29, 2011 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ⤷  Try it Free ⤷  Try it Free
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ⤷  Try it Free ⤷  Try it Free
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ⤷  Try it Free ⤷  Try it Free
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992 ⤷  Try it Free ⤷  Try it Free
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992 ⤷  Try it Free ⤷  Try it Free
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free PRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220
1853250 CA 2014 00034 Denmark ⤷  Try it Free PRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: EU/1/07/428 C(2013)9835 20131230
0961612 SZ 41/2009 Austria ⤷  Try it Free PRODUCT NAME: PACLITAXEL ALBUMIN
0961612 C00961612/01 Switzerland ⤷  Try it Free PRODUCT NAME: PACLITAXELUM-ALBUMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63182 26.08.2014
1853250 2014C/037 Belgium ⤷  Try it Free PRODUCT NAME: PACLITAXEL DANS UNE FORMULATION DE NANOPARTICULE LIEES A L'ALBUMINE; AUTHORISATION NUMBER AND DATE: EU/1/07/428 20131230
0961612 91613 Luxembourg ⤷  Try it Free 91613, EXPIRES: 20220924
0961612 132009901771196 Italy ⤷  Try it Free PRODUCT NAME: PACLITAXEL(ABRAXANE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/07/428/001, 20080114
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Merck
Boehringer Ingelheim
Colorcon
Harvard Business School
McKinsey

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