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Last Updated: August 15, 2022

Docetaxel - Generic Drug Details


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What are the generic sources for docetaxel and what is the scope of patent protection?

Docetaxel is the generic ingredient in three branded drugs marketed by Sun Pharm, Accord Hlthcare, Actavis Llc, Amneal, Apotex Inc, Dfb Oncology Ltd, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Hengrui Pharma, Hikma, Hospira Inc, Ingenus Pharms Llc, Meitheal, Mylan Labs Ltd, Pfizer Labs, Sandoz, Shilpa, Teva Pharms Usa, and Sanofi Aventis Us, and is included in twenty-five NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Docetaxel has fifty-four patent family members in twenty-six countries.

There are forty-one drug master file entries for docetaxel. Seventeen suppliers are listed for this compound.

Summary for docetaxel
Drug Prices for docetaxel

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Recent Clinical Trials for docetaxel

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

SponsorPhase
ParexelPhase 3
Dr. Victor H.F. LeePhase 2
Merck Sharp & Dohme LLCPhase 2

See all docetaxel clinical trials

Pharmacology for docetaxel
Drug Class Microtubule Inhibitor
Physiological EffectMicrotubule Inhibition
Paragraph IV (Patent) Challenges for DOCETAXEL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TAXOTERE Injection docetaxel 40 mg/mL, 0.5 mL and 2 mL vials 020449 1 2009-06-30

US Patents and Regulatory Information for docetaxel

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz DOCETAXEL docetaxel INJECTABLE;INJECTION 201525-002 Jun 29, 2011 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Shilpa DOCETAXEL docetaxel INJECTABLE;INJECTION 205934-003 Dec 22, 2015 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Hikma DOCETAXEL docetaxel INJECTABLE;INJECTION 204490-002 Jan 14, 2021 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Shilpa DOCETAXEL docetaxel INJECTABLE;INJECTION 205934-003 Dec 22, 2015 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-003 Aug 3, 2010 AP RX Yes Yes See Plans and Pricing See Plans and Pricing 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 docetaxel

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-001 May 14, 1996 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-003 Aug 3, 2010 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-001 May 14, 1996 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010 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 docetaxel

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Accord Healthcare S.L.U. Docetaxel Accord docetaxel EMEA/H/C/002539
Breast cancerDocetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.Docetaxel Accord in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.Docetaxel Accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.Docetaxel Accord in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.Docetaxel Accord in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small-cell lung cancerDocetaxel Accord is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Docetaxel Accord in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.Prostate cancerDocetaxel Accord in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.Gastric adenocarcinomaDocetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.Head and neck cancerDocetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Authorised yes no no 2012-05-22
Teva B.V.  Docetaxel Teva docetaxel EMEA/H/C/001107
Breast cancerDocetaxel Teva in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.Docetaxel Teva in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.Docetaxel Teva monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.Previous chemotherapy should have included an anthracycline or an alkylating agent.Docetaxel Teva in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.Docetaxel Teva in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small-cell lung cancerDocetaxel Teva is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Docetaxel Teva in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.Prostate cancerDocetaxel Teva in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.Gastric adenocarcinomaDocetaxel Teva in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.Head and neck cancerDocetaxel Teva in combination with cisplatin and 5 fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Withdrawn yes no no 2010-01-26
Sanofi Mature IP Taxotere docetaxel EMEA/H/C/000073
Breast cancerTaxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.Taxotere in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.Taxotere monotherapy is indicated for the treatment of patients with locally advanced ormetastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.Taxotere in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.Taxotere in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small-cell lung cancerTaxotere is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Taxotere in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.Prostate cancerTaxotere in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.Gastric adenocarcinomaTaxotere in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.Head and neck cancerTaxotere in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Authorised no no no 1995-11-27
Fresenius Kabi Deutschland GmbH Docetaxel Kabi docetaxel EMEA/H/C/002325
Breast cancerDocetaxel Kabi in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.Docetaxel Kabi in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.Docetaxel Kabi monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.Docetaxel Kabi in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.Docetaxel Kabi in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small-cell lung cancerDocetaxel Kabi is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Docetaxel Kabi in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.Prostate cancerDocetaxel Kabi in combination with prednisone or prednisolone is indicated for the treatment of patients with castration-resistant metastatic prostate cancer.Docetaxel Kabi in combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone, is indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer.Gastric adenocarcinomaDocetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.Head and neck cancerDocetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Authorised yes no no 2012-05-22
Zentiva k.s. Docetaxel Zentiva (previously Docetaxel Winthrop) docetaxel EMEA/H/C/000808
Breast cancerDocetaxel Winthrop in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.Docetaxel Winthrop in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.Docetaxel Winthrop monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.Docetaxel Winthrop in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.Docetaxel Winthrop in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small-cell lung cancerDocetaxel Winthrop is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Docetaxel Winthrop in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.Prostate cancerDocetaxel Winthrop in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer.Gastric adenocarcinomaDocetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.Head and neck cancerDocetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Withdrawn no no no 2007-04-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for docetaxel

Country Patent Number Title Estimated Expiration
Mexico 2015003824 FORMULACIONES DE NANODISPERSION DE TAXANO NO ACUOSAS Y METODOS PARA USAR LAS MISMAS. (NON-AQUEOUS TAXANE NANODISPERSION FORMULATIONS AND METHODS OF USING THE SAME.) See Plans and Pricing
Argentina 092759 FORMULACIONES EN FORMA DE NANODISPERSIONES NO ACUOSAS DE TAXANOS Y METODOS PARA USARLAS See Plans and Pricing
Malaysia 167224 Non-Aqueous Taxane Pro-Emulsion Formulations and Methods of Making and Using the Same See Plans and Pricing
Taiwan 201526889 Non-aqueous taxane pro-emulsion formulations and methods of making and using the same See Plans and Pricing
Taiwan 201417842 Non-aqueous taxane nanodispersion formulations and methods of using the same See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for docetaxel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1667986 92172 Luxembourg See Plans and Pricing PRODUCT NAME: SOLVAT ACETONIQUE DU CABAZITAXEL, OU DESIGNE SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL OU SOLVAT ACETONIQUE DU (2R,3S)-3-TERT-BUTOXYCARBONYLAMINO-2-HYDROXY-3-PHENYLPROPIONATE DE 4-ACETOXY-2A-BENZOYLOXY-5BETA,20-EPOXY-1-HYDROXY-7BETA,10A-DIMETHOXY-9-OXO-TAX-11-ENE-13A-YLE(ACETONATE DU CABAZITAXEL)
1667986 28/2013 Austria See Plans and Pricing PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
0253738 C960002 Netherlands See Plans and Pricing PRODUCT NAME: DOCETAXEL, DESGEWENST IN DE VORM VAN EEN TRIHYDRAAT; REGISTRATION NO/DATE: EU/1/95/002/001 - EU/1/95/002/002 19951127
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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