DOCETAXEL Drug Patent Profile

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

Docetaxel is a drug marketed by Accord Hlthcare, Actavis, Alembic, Amneal, Apotex Inc, Dfb Oncology Ltd, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Hengrui Pharma, Heritage, Hikma, Hospira Inc, Meitheal, Mylan Labs Ltd, Norvium Bioscience, Novast Labs, Pfizer Labs, Sandoz, Shilpa, Sun Pharm, and Teva Pharms Usa. and is included in twenty-seven NDAs. There are four patents protecting this drug.

This drug has fifty-three 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. Twenty-three 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 8^th, 2011.

Summary for DOCETAXEL

International Patents:	53
US Patents:	4
Applicants:	22
NDAs:	27
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	2,519
Patent Applications:	4,516
Drug Prices:	Drug price information for DOCETAXEL
What excipients (inactive ingredients) are in DOCETAXEL?	DOCETAXEL excipients list
DailyMed Link:	DOCETAXEL at DailyMed

See drug prices for DOCETAXEL

Recent Clinical Trials for DOCETAXEL

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

Sponsor	Phase
Beijing Konruns Pharmaceutical Co., Ltd.	Phase 3
Arcus Biosciences, Inc.	Phase 1
The First Affiliated Hospital of Xinxiang Medical College	Phase 2

See all DOCETAXEL clinical trials

Pharmacology for DOCETAXEL

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

Anatomical Therapeutic Chemical (ATC) Classes for DOCETAXEL

L01CD	Taxanes
L01C	PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira Inc	DOCETAXEL	docetaxel	INJECTABLE;INJECTION	022234-006	Jun 23, 2016		DISCN	Yes	No
Hengrui Pharma	DOCETAXEL	docetaxel	INJECTABLE;INJECTION	207252-003	Aug 9, 2017	AP	RX	No	No
Shilpa	DOCETAXEL	docetaxel	INJECTABLE;INJECTION	205934-003	Dec 22, 2015	AP	RX	Yes	Yes
Mylan Labs Ltd	DOCETAXEL	docetaxel	INJECTABLE;INJECTION	208137-001	Apr 1, 2019	AP	RX	No	No
Sandoz	DOCETAXEL	docetaxel	INJECTABLE;INJECTION	201525-001	Jun 29, 2011	AP	RX	No	No

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

International Patents for DOCETAXEL

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

Country	Patent Number	Title	Estimated Expiration
Japan	2013525485
Spain	2652509
Brazil	112012028037	formulação de pró-emulsão líquida de taxano não aquosa, métodos para administrar um taxano a um paciente e para fabricar uma formulação de pró-emulsão de taxano, composição de emulsão de taxano, e, kit
Malaysia	167224	Non-Aqueous Taxane Pro-Emulsion Formulations and Methods of Making and Using the Same
European Patent Office	2903435	FORMULATIONS DE NANODISPERSION NON AQUEUSE DE TAXANE ET PROCÉDÉS D'UTILISATION (NON-AQUEOUS TAXANE NANODISPERSION FORMULATIONS AND METHODS OF USING THE SAME)

Supplementary Protection Certificates for DOCETAXEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0253738	C960002	Netherlands		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		PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986	92172	Luxembourg		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)

DOCETAXEL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Docetaxel

Introduction

Docetaxel, a taxane chemotherapy drug, has been a cornerstone in the treatment of various cancers, including breast, prostate, non-small cell lung, and stomach cancers. Here, we delve into the market dynamics and financial trajectory of docetaxel, highlighting key drivers, market segmentation, and future projections.

Market Size and Growth

The global docetaxel market has been experiencing significant growth. As of 2023, the market size was valued at USD 114.78 billion and is projected to reach USD 252.46 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 9.70% during the forecast period of 2024-2032[1][4].

Drivers of the Market

Several factors are driving the growth of the docetaxel market:

Increasing Incidence of Cancer

The rising number of cancer cases globally is a primary driver. For instance, the American Cancer Society reported around 174,650 new cases of prostate cancer in the U.S. in 2019, and approximately 228,150 new cases of lung cancer were estimated in the same year[1].

Government Investments and R&D

Governments and pharmaceutical companies are heavily investing in research and development (R&D) to improve cancer treatments. This includes clinical trials and the development of new combination therapies. For example, Starpharma's phase 1 trial for DEP docetaxel with low toxicity is a significant advancement[1].

Product Innovations

The approval of new formulations, such as Eagle Pharmaceuticals' alcohol-free docetaxel injection, has expanded treatment options for patients with alcohol sensitivity. This innovation addresses a compelling need in the market and enhances patient care[2].

Market Segmentation

The docetaxel market is segmented based on application and end-users.

Application Segment

The market is segmented into breast cancer, prostate cancer, non-small cell lung cancer (NSCLC), ovarian cancer, and other cancers like stomach and head & neck cancers. Breast cancer is anticipated to lead the market due to its high prevalence and the established efficacy of docetaxel in treating various stages of breast cancer[1].

End-User Segment

The market is segmented into hospitals, specialty clinics, and oncology centers. The presence of multispecialty cancer hospitals and advanced chemotherapy treatments in regions like North America significantly boosts market growth in these areas[1].

Geographical Analysis

Geographically, the global docetaxel market is segmented into Americas, Europe, Asia Pacific (APAC), and Middle East & Africa (MEA).

Americas

The Americas, particularly North America, have a significant presence of multispecialty cancer hospitals and research centers, contributing to the region's market growth. The geriatric population in this region is also highly prone to cancer, further driving demand[1].

Europe

Europe is home to leading manufacturers such as Accord Healthcare and Sandoz, which positively impacts the regional market. The increasing demand for cancer drugs in chemotherapy is another key factor escalating regional growth[1].

Financial Trajectory

Price Dynamics

The prices of docetaxel have seen significant changes over its life cycle. Following the patent expiration in 2011, the prices dropped substantially, making the drug more accessible. However, the initial prices increased gradually after the product launch before declining sharply post-patent expiration[3].

Cost-Effectiveness

Studies have shown that the cost-effectiveness of docetaxel improves over its life cycle. The Incremental Cost-Effectiveness Ratio (ICER) decreases substantially as new indications are approved and prices drop. For instance, the ICER of docetaxel over a 20-year period was significantly lower than at its product launch, indicating long-term value[3].

Revenue Projections

The market is expected to continue its upward trajectory, driven by increasing demand and R&D activities. The projected market size of USD 252.46 billion by 2032 reflects the growing importance of docetaxel in cancer treatment[1][4].

Key Players

Several pharmaceutical companies are prominent in the docetaxel market, including:

• Beijing Union Pharmaceutical
• Sun Pharma
• Phyton
• Sandoz
• Aventis Pharma (Sanofi)
• Actavis
• Cisen Pharmaceutical
• Hospira
• Pfizer
• Taj Pharmaceuticals[4]

Regulatory Approvals and Innovations

Recent regulatory approvals have been crucial for market growth. For example, the FDA approval of Eagle Pharmaceuticals' alcohol-free docetaxel injection in 2015 marked a significant innovation, providing an alternative for patients with alcohol sensitivity[2].

Impact of Environmental Factors

Increasing environmental pollution in developed and developing regions, such as North America, Europe, and the Asia Pacific, is contributing to higher cancer incidence rates, thereby influencing the demand for docetaxel[1].

Conclusion

The docetaxel market is poised for substantial growth, driven by increasing cancer incidence rates, government investments in R&D, and innovations in drug formulations. The financial trajectory indicates a promising future with significant revenue projections and improved cost-effectiveness over the drug's life cycle.

Key Takeaways

• The global docetaxel market is expected to reach USD 252.46 billion by 2032, growing at a CAGR of 9.70%.
• Increasing cancer incidence rates and government investments in R&D are key drivers.
• The market is segmented into breast cancer, prostate cancer, NSCLC, ovarian cancer, and other cancers.
• North America and Europe are significant regions due to the presence of multispecialty cancer hospitals and leading manufacturers.
• The cost-effectiveness of docetaxel improves over its life cycle.
• Innovations such as alcohol-free formulations are expanding treatment options.

FAQs

What is the projected market size of the docetaxel market by 2032?

The global docetaxel market is expected to reach USD 252.46 billion by 2032[1].

What is the CAGR of the docetaxel market during the forecast period?

The docetaxel market is expected to grow at a CAGR of 9.70% during the forecast period of 2024-2032[1].

Which cancers are primarily treated with docetaxel?

Docetaxel is primarily used to treat breast cancer, prostate cancer, non-small cell lung cancer, ovarian cancer, and other cancers such as stomach and head & neck cancers[1].

What is the significance of the alcohol-free docetaxel formulation?

The alcohol-free docetaxel formulation, approved by the FDA in 2015, addresses the need for an alternative for patients with alcohol sensitivity, providing a more tolerable treatment option[2].

How does the cost-effectiveness of docetaxel change over its life cycle?

The cost-effectiveness of docetaxel improves significantly over its life cycle, with the ICER decreasing substantially as new indications are approved and prices drop post-patent expiration[3].

Sources

1. Straits Research: Docetaxel Market Size, Share & Analysis 2032.
2. Eagle Pharmaceuticals: Eagle Pharmaceuticals Announces FDA Approval of Docetaxel Injection.
3. American Journal of Managed Care: Dynamic Cost-Effectiveness of Oncology Drugs.
4. Business Research Insights: Docetaxel Market Size, Share, Trend & Growth [2032].