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Last Updated: October 6, 2022

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 three branded drugs marketed by Accord Hlthcare, Actavis Totowa, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, MSN, Mylan, Mylan Labs Ltd, Pliva Lachema, Sandoz Inc, Teva Pharms, Teva Pharms Usa, Hq Spclt Pharma, Abraxis Bioscience, and Hbt Labs Inc, and is included in eighteen NDAs. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are sixty-nine drug master file entries for paclitaxel. Thirteen 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
Institut de cancérologie Strasbourg EuropePhase 3
University Hospital HeidelbergPhase 1
German Cancer Research CenterPhase 1

See all paclitaxel clinical trials

Generic filers with tentative approvals for PACLITAXEL
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing100MGINJECTABLE;INJECTION

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 Class Microtubule Inhibitor
Physiological EffectMicrotubule Inhibition
Medical Subject Heading (MeSH) Categories for paclitaxel
Paragraph IV (Patent) Challenges for PACLITAXEL
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 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 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
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 paclitaxel

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
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992 See Plans and Pricing See Plans and Pricing
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992 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

EU/EMA Drug Approvals for paclitaxel

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
Norton Healthcare Ltd. Paxene paclitaxel EMEA/H/C/000216
Paxene is indicated for the treatment of patients with:• advanced AIDS-related Kaposi's sarcoma (AIDS-KS) who have failed prior liposomal anthracycline therapy;• metastatic carcinoma of the breast (MBC) who have failed, or are not candidates for standard anthracycline-containing therapy;• advanced carcinoma of the ovary (AOC) or with residual disease (> 1 cm) after initial laparotomy, in combination with cisplatin as first-line treatment;• metastatic carcinoma of the ovary (MOC) after failure of platinum-containing combination therapy without taxanes as second-line treatment;• non-small cell lung carcinoma (NSCLC) who are not candidates for potentially curative surgery and/or radiation therapy, in combination with cisplatin. Limited efficacy data supports this indication (see section 5.1).
Withdrawn no no no 1999-07-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for paclitaxel

Country Patent Number Title Estimated Expiration
Portugal 2097078 See Plans and Pricing
China 103285395 Combinations and modes of administration of therapeutic agents and combination therapy See Plans and Pricing
China 103169729 Methods and compositions for treating proliferative diseases See Plans and Pricing
China 104940929 Nanoparticles of paclitaxel and albumin in combination with bevacizumab against cancer See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for paclitaxel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1853250 2014C/037 Belgium See Plans and Pricing PRODUCT NAME: PACLITAXEL DANS UNE FORMULATION DE NANOPARTICULE LIEES A L'ALBUMINE; AUTHORISATION NUMBER AND DATE: EU/1/07/428 20131230
1853250 C300673 Netherlands See Plans and Pricing PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
0961612 09C0050 France See Plans and Pricing PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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