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Last Updated: February 23, 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, Mylan, Pliva Lachema, Sandoz, Teva Pharms, Teva Pharms Usa, Hq Spclt Pharma, Bristol-myers, Am Regent, and Teva Pharms Inc, and is included in twenty 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-one patent family members in thirty-one countries.

There are sixty-nine drug master file entries for paclitaxel. Seventeen 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
Cancer Cures 4 KidsPhase 1
Aston Sci. Inc.Phase 2
Chengdu First people's hospitalPhase 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 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
Teva Pharms Inc PACLITAXEL paclitaxel POWDER;INTRAVENOUS 216338-001 May 11, 2023 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dash Pharms PACLITAXEL paclitaxel INJECTABLE;INJECTION 091540-001 Sep 29, 2011 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol-myers ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol-myers ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Teva Pharms Usa PACLITAXEL paclitaxel INJECTABLE;INJECTION 075297-001 Jan 25, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992 ⤷  Try a Trial ⤷  Try a Trial
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992 ⤷  Try a Trial ⤷  Try a Trial
Bristol-myers ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 ⤷  Try a Trial ⤷  Try a Trial
Bristol-myers ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 ⤷  Try a Trial ⤷  Try a Trial
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992 ⤷  Try a Trial ⤷  Try a Trial
>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
European Patent Office 1853250 COMBINAISONS ET MODES D'ADMINISTRATION D'AGENTS THERAPEUTIQUES ET TRAITEMENT COMBINE (COMBINATIONS AND MODES OF ADMINISTRATION OF THERAPEUTIC AGENTS AND COMBINATION THERAPY) ⤷  Try a Trial
Israel 272905 שיטות לטיפול בסרטן הלבלב (Methods of treating pancreatic cancer) ⤷  Try a Trial
South Korea 20200083657 약리학적 물질의 조성물 및 그 전달방법 (Compositions and methods of delivery of pharmacological agents) ⤷  Try a Trial
Israel 273765 צירופים וצורות מתן של גורמים טיפוליים וטיפול משולב (Combinations and modes of administration of therapeutic agents and combination therapy) ⤷  Try a Trial
South Korea 102205710 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for paclitaxel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1853250 C300673 Netherlands ⤷  Try a Trial PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
1853250 132014902271575 Italy ⤷  Try a Trial PRODUCT NAME: PACLITAXEL LEGATO ALL'ALBUMINA FORMULATO IN NANOPARTICELLE(ABRAXANE); AUTHORISATION NUMBER(S) AND DATE(S): EU/01/07/428, 20131220
0961612 C00961612/01 Switzerland ⤷  Try a Trial PRODUCT NAME: PACLITAXELUM-ALBUMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63182 26.08.2014
1853250 300673 Netherlands ⤷  Try a Trial PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
0961612 CA 2009 00036 Denmark ⤷  Try a Trial PRODUCT NAME: PACLITAXELALBUMIN
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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