Cabazitaxel - Generic Drug Details

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

Cabazitaxel is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Actavis, Apotex, Breckenridge, Dr Reddys, Mylan Labs Ltd, and Sanofi Aventis Us, and is included in eight NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cabazitaxel has ninety-six patent family members in forty-six countries.

There are thirteen drug master file entries for cabazitaxel. One supplier is listed for this compound. There are three tentative approvals for this compound.

Summary for cabazitaxel

International Patents:	96
US Patents:	4
Tradenames:	2
Applicants:	7
NDAs:	8
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	127
Patent Applications:	4,299
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cabazitaxel
What excipients (inactive ingredients) are in cabazitaxel?	cabazitaxel excipients list
DailyMed Link:	cabazitaxel at DailyMed

Recent Clinical Trials for cabazitaxel

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

Sponsor	Phase
Fundacion Oncosur	Phase 2
MacroGenics	Phase 2/Phase 3
Peter MacCallum Cancer Centre, Australia	Phase 1/Phase 2

See all cabazitaxel clinical trials

Generic filers with tentative approvals for CABAZITAXEL

Applicant	Application No.	Strength	Dosage Form
		UNKNOWN	UNKNOWN
		20MG/ML	INJECTABLE;INJECTION
		45MG/4.5ML (10MG/ML)	SOLUTION;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for cabazitaxel

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

Paragraph IV (Patent) Challenges for CABAZITAXEL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JEVTANA KIT	Injection	cabazitaxel	60 mg/1.5 mL	201023	8	2014-06-17

US Patents and Regulatory Information for cabazitaxel

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord Hlthcare	CABAZITAXEL	cabazitaxel	SOLUTION;INTRAVENOUS	207949-001	Dec 29, 2021		DISCN	Yes	No
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010	AP	RX	Yes	Yes	7,241,907*PED				Y
Apotex	CABAZITAXEL	cabazitaxel	SOLUTION;INTRAVENOUS	207736-001	Feb 10, 2023		DISCN	No	No

Expired US Patents for cabazitaxel

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010	5,438,072
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010	6,372,780
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010	6,331,635

EU/EMA Drug Approvals for cabazitaxel

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Accord Healthcare S.L.U.	Cabazitaxel Accord	cabazitaxel	EMEA/H/C/005178 Treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.	Authorised	yes	no	no	2020-08-28
Sanofi Winthrop Industrie	Jevtana	cabazitaxel	EMEA/H/C/002018 Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.	Authorised	no	no	no	2011-03-17
Teva B.V.	Cabazitaxel Teva	cabazitaxel	EMEA/H/C/004951 Treatment of prostate cancer	Refused	no	no	no		2019-07-11

International Patents for cabazitaxel

Country	Patent Number	Title	Estimated Expiration
Mexico	2012005030	NUEVO USO ANTITUMORAL DE CABAZITAXEL. (NOVEL ANTITUMORAL USE OF CABAZITAXEL.)
South Korea	20120093986
Russian Federation	2342373	АЦЕТОНОВЫЙ СОЛЬВАТ ДИМЕТОКСИДОЦЕТАКСЕЛА И СПОСОБ ЕГО ПОЛУЧЕНИЯ (ACETONE SOLVATE OF DIMETHOXY DOCETAXEL AND METHOD OF OBTAINING IT)

Supplementary Protection Certificates for cabazitaxel

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1667986	C01667986/01	Switzerland		PRODUCT NAME: CABAZITAXELUM; REGISTRATION NO/DATE: SWISSMEDIC 61543 06.04.2011
1667986	2013/021	Ireland		PRODUCT NAME: CABAZITAXEL ACETONE SOLVATE; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986	SPC/GB13/042	United Kingdom		PRODUCT NAME: CABAZITAXEL IN THE FORM OF THE ACETONE SOLVATE; REGISTERED: UK EU/1/11/676/001 20110317

Cabazitaxel Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory of Cabazitaxel

Introduction

Cabazitaxel, a potent chemotherapeutic agent, has been a cornerstone in the treatment of metastatic castration-resistant prostate cancer (mCRPC), particularly for patients who have failed prior treatments such as docetaxel and androgen receptor signaling inhibitors. Here, we delve into the market dynamics and financial trajectory of cabazitaxel, highlighting its current status, growth prospects, and key factors influencing its market.

Market Size and Growth Projections

The global cabazitaxel market is experiencing significant growth, driven by several key factors. As of 2023, the market size was valued at approximately USD 1.8 billion and is projected to reach USD 2.7 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.2% from 2024 to 2031[4].

In a more specific forecast, the market is expected to grow from USD 215.2 million in 2024 to USD 293.4 million by 2030, at a CAGR of 5.3% during the same period[1].

Key Drivers of Market Growth

Several factors are contributing to the robust growth of the cabazitaxel market:

Increasing Incidence of Prostate Cancer

The rising incidence of prostate cancer globally is a major driver. As the population ages and awareness about prostate cancer increases, the demand for effective treatments like cabazitaxel is on the rise[4].

Efficacy in Advanced Prostate Cancer

Cabazitaxel's effectiveness in treating patients who have not responded to prior treatments, such as docetaxel and androgen receptor signaling inhibitors, makes it a preferred option in the oncology segment[5].

Expanding Indications

The growing list of indications for cabazitaxel, including its use in combination therapy, further boosts its market demand. This versatility in treatment options is attracting more patients and healthcare providers[4].

Advances in Oncology Research

Developments in oncology research, particularly in customized and targeted therapies, are enhancing the appeal of cabazitaxel. Ongoing clinical trials and increasing awareness among patients and healthcare professionals about the benefits of targeted medicines are also driving market growth[4].

Market Segmentation

The cabazitaxel market is segmented based on several criteria:

By Application

• Cancer Treatment
• Prostate Cancer Therapy
• Oncology

These segments highlight the diverse uses of cabazitaxel across various cancer treatments, with a significant focus on prostate cancer therapy[4].

By Product

• Injection Solution
• Powder for Injection
• Infusion Solution

The different product forms cater to various clinical needs and preferences, contributing to the market's growth[4].

By Geography

• North America
• Europe
• Asia-Pacific
• Middle East and Africa
• South America

North America, particularly the USA, holds a significant market share, followed by Europe. The Asia-Pacific region is also expected to show substantial growth due to increasing healthcare spending and awareness[1][4].

Competitive Landscape

The cabazitaxel market is dominated by a few key players:

Major Companies

• Sanofi
• Teva
• Pfizer
• Novartis
• Mylan
• Fresenius Kabi
• Lupin
• Dr. Reddy's Laboratories
• Gilead Sciences
• Bayer

These companies are profiled based on their product offerings, market entry year, and other market-related factors. The competitive landscape is characterized by high competition, with top companies occupying a significant market share[4].

Financial Performance and Budgetary Impact

Revenue and Market Share

The top three companies in the cabazitaxel market occupy about 99% of the market share, indicating a highly concentrated market. The revenue generated from cabazitaxel sales is substantial, with Sanofi being a major player given its historical involvement in the development and marketing of the drug[1].

Budgetary Impact

Studies have shown that an increase in cabazitaxel use can result in modest cost savings to health plans. This is due to its efficacy in treating advanced prostate cancer, which can reduce the overall cost of care by minimizing the need for additional treatments and hospitalizations[2].

Porter’s Five Forces Analysis

The market dynamics of cabazitaxel can be further understood through a Porter’s Five Forces analysis:

Bargaining Power of Buyers

Moderate to high, due to the presence of health insurance plans and government healthcare programs that can influence pricing.

Bargaining Power of Suppliers

Moderate, as the market is dominated by a few key suppliers, but there is still competition among them.

Threat of New Entrants

Low, due to the high barriers to entry, including regulatory approvals and significant research and development costs.

Threat of Substitutes

Moderate, as there are other chemotherapy agents available, but cabazitaxel's unique efficacy profile reduces this threat.

Degree of Competition

High, due to the concentrated market with a few major players competing for market share[4].

Conclusion

The cabazitaxel market is poised for significant growth driven by its efficacy in treating advanced prostate cancer, expanding indications, and advances in oncology research. The market is segmented by application, product form, and geography, with North America and Europe being the largest markets. The competitive landscape is dominated by a few key players, and the financial performance indicates substantial revenue and cost savings potential.

Key Takeaways

• The global cabazitaxel market is projected to grow from USD 1.8 billion in 2023 to USD 2.7 billion by 2031.
• The market is driven by the increasing incidence of prostate cancer, cabazitaxel's efficacy, and advances in oncology research.
• The market is segmented by application, product form, and geography.
• Major players like Sanofi, Teva, and Pfizer dominate the market.
• Cabazitaxel use can result in modest cost savings to health plans.

FAQs

What is the current market size of cabazitaxel and its projected growth?

The current market size of cabazitaxel was valued at approximately USD 1.8 billion in 2023 and is expected to reach USD 2.7 billion by 2031, growing at a CAGR of 5.2% from 2024 to 2031[4].

What are the key drivers of the cabazitaxel market growth?

Key drivers include the increasing incidence of prostate cancer, cabazitaxel's efficacy in treating advanced prostate cancer, expanding indications, and advances in oncology research[4].

Who are the major players in the cabazitaxel market?

Major players include Sanofi, Teva, Pfizer, Novartis, Mylan, Fresenius Kabi, Lupin, Dr. Reddy's Laboratories, Gilead Sciences, and Bayer[4].

How does cabazitaxel impact health plan budgets?

An increase in cabazitaxel use is expected to result in modest cost savings to health plans due to its efficacy in treating advanced prostate cancer, which can reduce overall healthcare costs[2].

What regions dominate the cabazitaxel market?

North America, particularly the USA, holds the largest market share, followed by Europe. The Asia-Pacific region is also expected to show significant growth[1][4].