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Last Updated: September 26, 2022

DOCETAXEL Drug Patent Profile


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When do Docetaxel patents expire, and what generic alternatives are available?

Docetaxel is a drug marketed by 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 Sun Pharm. and is included in twenty-four NDAs. There are four patents protecting this drug.

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

The generic ingredient in DOCETAXEL is docetaxel. There are forty-one drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the docetaxel profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Docetaxel

A generic version of DOCETAXEL was approved as docetaxel by HOSPIRA INC on March 8th, 2011.

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Summary for DOCETAXEL
Drug patent expirations by year for DOCETAXEL
Drug Prices for DOCETAXEL

See drug prices for DOCETAXEL

Recent Clinical Trials for DOCETAXEL

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

SponsorPhase
ParexelPhase 3
Dr. Victor H.F. LeePhase 2
Zhenzhen LiuPhase 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

DOCETAXEL is protected by ten US patents.

Patents protecting DOCETAXEL

Non-aqueous taxane pro-emulsion formulations and methods of making and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF ADMINISTERING DOCETAXEL TO A SUBJECT COMBINING THE DOCETAXEL PRO-EMULSION FORMULATION WITH AN AQUEOUS MEDIUM TO PRODUCE DOCETAXEL EMULSION

Non-aqueous taxane nanodispersion formulations and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF ADMINISTERING AN ETHANOL-FREE TAXANE LIQUID NANODISPERSION FORMULATION TO A SUBJECT COMBINING THE FORMULATION WITH AN AQUEOUS MEDIUM TO PROVIDE AN ETHANOL-FREE TAXANE DILUTED SOLUTION

Non-aqueous taxane formulations and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Non-aqueous taxane formulations and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER AFTER FAILURE OF PRIOR PLATINUM-BASED CHEMOTHERAPY

Non-aqueous taxane formulations and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK IN COMBINATION WITH CISPLATIN AND FLUOROURACIL

Non-aqueous taxane formulations and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN COMBINATION WITH DOXORUBICIN AND CYCLOPHOSPHAMIDE FOR ADJUVANT TREATMENT OF PATIENTS WITH OPERABLE NODE-POSITIVE BREAST CANCER

Non-aqueous taxane formulations and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH LOCALLY ADVANCED METASTATIC BREAST CANCER AFTER FAILURE OF PRIOR CHEMOTHERAPY

Non-aqueous taxane formulations and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADVANCED GASTRIC ADENOCARCINOMA IN COMBINATION WITH CISPLATIN AND FLUOROURACIL IN PATIENTS THAT HAVE NOT RECEIVED PRIOR CHEMOTHERAPY

Non-aqueous taxane formulations and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN COMBINATION WITH CISPLATIN FOR TREATMENT OF UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITHOUT PRIOR CHEMOTHERAPY TREATMENT

Non-aqueous taxane formulations and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH ANDROGEN INDEPENDENT (HORMONE REFRACTORY) METASTATIC PROSTATE CANCER IN COMBINATION WITH PREDNISONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ingenus Pharms Llc DOCETAXEL docetaxel INJECTABLE;INJECTION 207563-003 Aug 31, 2017 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hospira Inc DOCETAXEL docetaxel INJECTABLE;INJECTION 022234-001 Mar 8, 2011 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer Labs DOCETAXEL docetaxel INJECTABLE;INJECTION 202356-001 Mar 13, 2014 DISCN No No 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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for DOCETAXEL

See the table below for patents covering DOCETAXEL around the world.

Country Patent Number Title Estimated Expiration
China 102970990 Non-aqueous taxane pro-emulsion formulations and methods of making and using the same See Plans and Pricing
China 108464969 非水紫杉烷纳米分散制剂及其使用方法 (NON-AQUEOUS TAXANE NANODISPERSION FORMULATIONS AND METHODS OF USING THE SAME) See Plans and Pricing
Jordan 3685 صيغ التشتيت الجسيمي للتاكسين غير المائي وطرق استخدامها (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
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
1667986 28/2013 Austria See Plans and Pricing PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
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)
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.