DOCEFREZ Drug Patent Profile

Which patents cover Docefrez, and when can generic versions of Docefrez launch?

Docefrez is a drug marketed by Sun Pharm and is included in one NDA.

The generic ingredient in DOCEFREZ 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 Docefrez

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

Summary for DOCEFREZ

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	14
Patent Applications:	4,533
DailyMed Link:	DOCEFREZ at DailyMed

Recent Clinical Trials for DOCEFREZ

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

Sponsor	Phase
OncoC4, Inc.	Phase 3
NuCana plc	Phase 1/Phase 2
G1 Therapeutics, Inc.	Phase 2

See all DOCEFREZ clinical trials

Pharmacology for DOCEFREZ

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

US Patents and Regulatory Information for DOCEFREZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	DOCEFREZ	docetaxel	INJECTABLE;INJECTION	022534-001	May 3, 2011		DISCN	Yes	No
Sun Pharm	DOCEFREZ	docetaxel	INJECTABLE;INJECTION	022534-002	May 3, 2011		DISCN	Yes	No

EU/EMA Drug Approvals for DOCEFREZ

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

Market Dynamics and Financial Trajectory for Docetaxel

Introduction to Docetaxel

Docetaxel is a chemotherapy medication used to treat various types of cancer, including breast, prostate, stomach, and non-small cell lung cancers. The drug has been a cornerstone in oncology treatment, and its market is experiencing significant growth driven by several key factors.

Market Size and Growth

The global docetaxel market is substantial and growing rapidly. 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].

Driving Factors

Increasing Cancer Prevalence

The rising incidence of cancers such as breast, prostate, and non-small cell lung cancer is a major driver of the docetaxel market. For instance, the American Cancer Society reported around 174,650 new cases of prostate cancer in the U.S. in 2019, and the National Cancer Institute estimated 228,150 new cases of lung cancer in the same year[1].

Advancements in Treatment

Docetaxel-based chemotherapy has shown improved survival rates, particularly in castration-sensitive prostate cancers. The drug is well-tolerated by patients, which further boosts its demand. Additionally, innovations in drug delivery systems and combination therapies are enhancing the efficacy of docetaxel, contributing to market growth[1][3].

Government and R&D Investments

Governments and pharmaceutical companies are heavily investing in research and development (R&D) to improve cancer treatments. Clinical trials and approvals for new formulations, such as the FDA approval for Eagle Pharmaceuticals' non-alcohol formula of docetaxel, are supporting market expansion[1].

Environmental and Demographic Factors

Increasing environmental pollution and an aging population are also influencing the demand for docetaxel. The geriatric population is more prone to cancer, and regions like North America and Europe have a significant elderly population, which is driving market growth in these areas[1].

Market Segmentation

By Application

The docetaxel market is segmented into various cancer types, including breast cancer, prostate cancer, non-small cell lung cancer (NSCLC), ovarian cancer, and others. Breast cancer is expected to lead the market due to its high prevalence worldwide and the established effectiveness of docetaxel in treating this condition[1].

By End User

The market is also segmented by end users, including hospitals, specialty clinics, and oncology centers. These segments are crucial as they represent the primary points of care where docetaxel is administered[1].

Geographical Analysis

North America

North America is the largest market for docetaxel, driven by the presence of advanced chemotherapy treatments, multispecialty cancer hospitals, and a significant geriatric population. The region saw around 140,690 new cancer cases among individuals aged 85 and older in 2019[1].

Europe

Europe is another significant market, with leading manufacturers like Accord Healthcare and Sandoz contributing to the regional growth. The increasing demand for cancer drugs in chemotherapy is further escalating the market in this region[1].

Asia Pacific

The Asia Pacific region is expected to witness the highest growth due to developing healthcare infrastructure, rising disposable incomes, and a growing patient population in countries like China and India[3].

Market Trends

Targeted Therapies

The oncology drugs market, including docetaxel, is shifting towards targeted therapies and immunotherapies. These innovative treatments have higher efficacy and reduced side effects, which is fueling market growth. By 2031, targeted therapies are expected to surpass cytotoxic drugs as the largest segment in the oncology drugs market[3].

Combination Therapies

The use of docetaxel in combination with other drugs is becoming more prevalent. For example, Genentech's subcutaneous injection for certain HER2-positive breast cancers and Bristol-Myers Squibb's combination formula of docetaxel under phase III trials are indicative of this trend[1].

Competitive Landscape

The docetaxel market is competitive, with key players including:

• Hoffmann-La Roche Ltd.
• Genentech, Inc.
• Novartis AG
• Gilead Sciences Inc.
• AstraZeneca
• Pfizer Inc.
• Sandoz
• Actavis
• Taj Pharmaceuticals[1][4].

Financial Projections

The financial trajectory of the docetaxel market is robust, with a projected CAGR of 9.70% from 2024 to 2032. Here are some key financial projections:

• 2023 Market Size: USD 114.78 billion
• 2032 Market Size: USD 252.46 billion
• CAGR: 9.70%[1].

Revenue Forecast

The revenue forecast for the docetaxel market is positive, driven by increasing demand and advancements in treatment options. The market is expected to more than double by 2032, indicating a strong financial outlook[1][4].

Key Takeaways

• The global docetaxel market is valued at USD 114.78 billion in 2023 and is expected to reach USD 252.46 billion by 2032.
• The market is driven by increasing cancer prevalence, advancements in treatment, and government and R&D investments.
• Breast cancer is the leading application segment due to its high prevalence and the effectiveness of docetaxel.
• North America is the largest market, while the Asia Pacific region is expected to witness the highest growth.
• The market is shifting towards targeted therapies and combination treatments.

FAQs

What is the current market size of the global docetaxel market?

The global docetaxel market size was valued at USD 114.78 billion in 2023[1].

What is the projected CAGR for the docetaxel market from 2024 to 2032?

The docetaxel market is expected to grow at a CAGR of 9.70% from 2024 to 2032[1].

Which segment is expected to lead the docetaxel market by application?

Breast cancer is anticipated to lead the market due to its high prevalence worldwide and the established effectiveness of docetaxel in treating this condition[1].

What are the key geographical markets for docetaxel?

North America is the largest market, followed by Europe, while the Asia Pacific region is expected to witness the highest growth[1][3].

Who are some of the key players in the docetaxel market?

Key players include Hoffmann-La Roche Ltd., Genentech, Inc., Novartis AG, Gilead Sciences Inc., AstraZeneca, Pfizer Inc., Sandoz, Actavis, and Taj Pharmaceuticals[1][4].

Sources

1. Straits Research: Docetaxel Market Size, Share & Analysis 2032.
2. Cognitivemarketresearch: Docetaxel Market Report 2024 (Global Edition).
3. Coherent Market Insights: Oncology Drugs Market to Reach USD 532.91 Billion by 2031.
4. Business Research Insights: Docetaxel Market Size, Share, Trend & Growth [2032].