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Last Updated: December 4, 2024

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 three branded drugs marketed by Accord Hlthcare, Actavis Totowa, Alembic, Dash Pharms, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, MSN, Norvium Bioscience, Pliva Lachema, Sandoz, Teva Pharms, Teva Pharms Usa, Hq Spclt Pharma, Bristol-myers, Am Regent, Hengrui Pharma, and Teva Pharms Inc, and is included in twenty-one 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. Nineteen 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
Vall d'Hebron Institute of OncologyPhase 2
Lee Ocuin, MDPhase 2
NorthShore University HealthSystemN/A

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 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
Hospira PACLITAXEL paclitaxel INJECTABLE;INJECTION 076233-001 Aug 1, 2002 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol-myers ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msn PACLITAXEL paclitaxel INJECTABLE;INJECTION 213434-001 Aug 24, 2020 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Am Regent PACLITAXEL paclitaxel POWDER;INTRAVENOUS 211875-001 Jul 27, 2022 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa PACLITAXEL paclitaxel INJECTABLE;INJECTION 077574-001 Nov 27, 2006 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol-myers ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
Bristol-myers ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 ⤷  Sign Up ⤷  Sign Up
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992 ⤷  Sign Up ⤷  Sign Up
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992 ⤷  Sign Up ⤷  Sign Up
Bristol-myers ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 ⤷  Sign Up ⤷  Sign Up
Bristol-myers ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 ⤷  Sign Up ⤷  Sign Up
Bristol-myers ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 ⤷  Sign Up ⤷  Sign Up
>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
Hungary E038768 ⤷  Sign Up
European Patent Office 2301531 COMBINAISONS ET MODES D'ADMINISTRATION D'AGENTS THERAPEUTIQUES ET TRAITEMENT COMBINE (COMBINATIONS AND MODES OF ADMINISTRATION OF THERAPEUTIC AGENTS AND COMBINATION THERAPY) ⤷  Sign Up
New Zealand 560879 Combinations and modes of administration of therapeutic agents and combination therapy ⤷  Sign Up
South Korea 101894689 ⤷  Sign Up
South Korea 20140016402 COMBINATIONS AND MODES OF ADMINISTRATION OF THERAPEUTIC AGENTS AND COMBINATION THERAPY ⤷  Sign Up
Mexico 2012011072 METODOS PARA TRATAR EL CANCER. (METHODS OF TREATING CANCER.) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for paclitaxel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1853250 238 50005-2014 Slovakia ⤷  Sign Up PRODUCT NAME: PAKLITAXEL VO FORME NANOCASTIC VIAZANYCH NA ALBUMIN; REGISTRATION NO/DATE: EU/1/07/428/001 - EU/1/07/428/002 20131230
1853250 122014000065 Germany ⤷  Sign Up PRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220
1853250 CA 2014 00034 Denmark ⤷  Sign Up PRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: EU/1/07/428 C(2013)9835 20131230
0961612 SZ 41/2009 Austria ⤷  Sign Up PRODUCT NAME: PACLITAXEL ALBUMIN
0961612 300417 Netherlands ⤷  Sign Up PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080114
0961612 09C0050 France ⤷  Sign Up 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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