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Last Updated: January 7, 2025

CABAZITAXEL Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Cabazitaxel

A generic version of CABAZITAXEL was approved as cabazitaxel by ACCORD HLTHCARE on October 26th, 2022.

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Drug patent expirations by year for CABAZITAXEL
Recent Clinical Trials for CABAZITAXEL

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

SponsorPhase
Fundacion OncosurPhase 2
MacroGenicsPhase 2/Phase 3
Peter MacCallum Cancer Centre, AustraliaPhase 1/Phase 2

See all CABAZITAXEL clinical trials

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan Labs Ltd CABAZITAXEL cabazitaxel SOLUTION;INTRAVENOUS 207381-001 Jul 5, 2023 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apotex CABAZITAXEL cabazitaxel SOLUTION;INTRAVENOUS 207736-001 Feb 10, 2023 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Accord Hlthcare CABAZITAXEL cabazitaxel SOLUTION;INTRAVENOUS 207693-001 Oct 26, 2022 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Actavis CABAZITAXEL cabazitaxel SOLUTION;INTRAVENOUS 207970-001 Mar 14, 2024 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys CABAZITAXEL cabazitaxel SOLUTION;INTRAVENOUS 207718-001 Feb 10, 2023 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>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 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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].

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