JEVTANA KIT Drug Patent Profile

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

Jevtana Kit is a drug marketed by Sanofi Aventis Us and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-seven patent family members in forty-seven countries.

The generic ingredient in JEVTANA KIT is cabazitaxel. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cabazitaxel profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Jevtana Kit

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

Summary for JEVTANA KIT

International Patents:	97
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	54
Patent Applications:	1,920
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JEVTANA KIT
DailyMed Link:	JEVTANA KIT at DailyMed

Recent Clinical Trials for JEVTANA KIT

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

Sponsor	Phase
Andrew J. Armstrong, MD	Phase 2
Janssen Pharmaceutica	Phase 2
Oregon Health and Science University	Phase 1

See all JEVTANA KIT clinical trials

Paragraph IV (Patent) Challenges for JEVTANA KIT

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 JEVTANA KIT

JEVTANA KIT is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010	AP	RX	Yes	Yes	10,583,110
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010	AP	RX	Yes	Yes	7,241,907*PED				Y
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010	AP	RX	Yes	Yes	10,716,777
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010	AP	RX	Yes	Yes	8,927,592*PED				Y

Expired US Patents for JEVTANA KIT

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	6,387,946
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010	6,331,635
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010	5,698,582

EU/EMA Drug Approvals for JEVTANA KIT

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

International Patents for JEVTANA KIT

See the table below for patents covering JEVTANA KIT around the world.

Country	Patent Number	Title	Estimated Expiration
China	1152870
Hungary	222833	Taxánszármazékot tartalmazó injektálható gyógyszerkészítmények (INJECTABLE MEDICAMENTS CONTAINING TAXANE DERIVATIVES)
New Zealand	258150	TWO PART INJECTABLE TAXANE DERIVATIVE COMPOSITIONS: ACTIVE AGENT, SURFACTANT AND A DILUTION ADDITIVE
Norway	2015013

Supplementary Protection Certificates for JEVTANA KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1667986	C 2013 017	Romania		PRODUCT NAME: SOLVAT ACETONIC DE CABAZITAXEL; NATIONAL AUTHORISATION NUMBER: EU/1/11/676/001; DATE OF NATIONAL AUTHORISATION: 20110317; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/676/001; DATE OF FIRST AUTHORISATION IN EEA: 20110317
1667986	C01667986/01	Switzerland		PRODUCT NAME: CABAZITAXELUM; REGISTRATION NO/DATE: SWISSMEDIC 61543 06.04.2011
1667986	PA2013010	Lithuania		PRODUCT NAME: CABAZITAXELUM; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986	PA2013010,C1667986	Lithuania		PRODUCT NAME: CABAZITAXELUM; REGISTRATION NO/DATE: EU/1/11/676/001 20110317

Market Dynamics and Financial Trajectory for Jevtana Kit

Market Introduction

Jevtana, also known as cabazitaxel, is an antineoplastic drug specifically designed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). It is administered intravenously and often used in conjunction with prednisone. The drug has become a significant player in the oncology market, particularly as a second-line treatment following the failure of hormone therapy[1][3][4].

Market Growth Drivers

The Jevtana market is driven by several key factors:

Rising Prostate Cancer Incidence

The global incidence of prostate cancer is increasing, especially among aging populations. Prostate cancer is the second most common cancer in men, and its prevalence is expected to rise as life expectancy increases. This surge in cases creates a larger patient pool for Jevtana and similar treatments[3].

Increased Focus on Oncology and Cancer Research

The healthcare industry is allocating more resources to oncology research, leading to faster drug approvals, improved treatment protocols, and more effective therapies. Governments and private organizations are investing heavily in cancer treatment, which benefits drugs like Jevtana[3].

Emerging Markets

The adoption of advanced cancer treatments like Jevtana is expanding in regions such as Asia-Pacific, Latin America, and the Middle East. These regions are investing in healthcare infrastructure, leading to greater access to innovative cancer treatments. As healthcare systems in these markets improve, the demand for Jevtana is expected to grow[3].

Market Dynamics

The Jevtana market is characterized by several dynamics:

Demand and Supply Side Factors

The demand for Jevtana is driven by the increasing need for effective treatments for mCRPC. On the supply side, pharmaceutical companies like Sanofi, Tapi Teva, Fuan Pharmaceutical Group, and Fujian Yewpark Biological are key players, focusing on organic and inorganic growth strategies such as product launches, acquisitions, and partnerships[1][4].

Regulatory Environment

Regulatory agencies are prioritizing cancer treatments that show clear efficacy in improving patient outcomes, leading to faster market entry for innovative therapies like Jevtana. Accelerated regulatory approvals in major markets like the U.S., Europe, and Japan have been instrumental in the drug's market expansion[3].

Financial Trajectory

The financial trajectory of the Jevtana market is promising:

Market Size and Growth Rate

The global Jevtana market is projected to grow at a CAGR of 7-9% over the next several years. This growth is driven by the rising incidence of prostate cancer, increasing adoption of advanced treatments, and the expansion of the drug into new geographic markets[3].

Revenue and Volume Forecast

The market is expected to witness significant revenue growth, with forecasts indicating substantial increases in both value and volume. The report coverage includes revenue and volume forecasts, company share, competitive landscape, growth factors, and trends[4].

Key Players and Their Strategies

Companies like Sanofi are major players in the Jevtana market. Sanofi's financial reports indicate a strong focus on oncology, with significant investments in research and development. These companies are engaging in organic and inorganic growth strategies, including product launches, acquisitions, and partnerships to expand their market share[1][4][5].

Challenges and Restraints

Despite the positive growth trajectory, the Jevtana market faces some challenges:

Adverse Effects

One of the significant restraints is the increased risk of adverse effects associated with the drug. These side effects can hamper the growth of the global Jevtana market[1].

Competition and Pricing

The market is competitive, with other treatments and therapies vying for market share. Pricing strategies and competition from generic versions of cabazitaxel could also impact the market dynamics[1][4].

Regional Framework

The Jevtana market is analyzed across various regions, including North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA), and South & Central America. Each region is sub-segmented by country, providing a detailed overview of the industry's qualitative and quantitative information. The report covers analysis and forecast of 18 countries globally, highlighting current trends and opportunities prevailing in each region[1].

Innovations and Future Trends

Recent advancements in cancer treatment, particularly in personalized medicine, have positively impacted the Jevtana market. Innovations include new drug combinations with immunotherapy and PARP inhibitors, as well as advancements in drug delivery methods to enhance the effectiveness of Jevtana while minimizing side effects. These innovations are expected to broaden the use of Jevtana in different stages of prostate cancer treatment, further boosting its market potential[3].

Investment Opportunities

The Jevtana market presents several investment opportunities:

Pharmaceutical Companies

Investing in pharmaceutical companies involved in oncology research, such as Sanofi and Tapi Teva, can be lucrative. These companies are at the forefront of developing and marketing effective cancer treatments[3].

R&D Investments

Investments in research and development focused on cancer therapies, particularly those involving innovative drug combinations and delivery methods, are promising. Partnerships focusing on these areas can also yield significant returns[3].

Emerging Markets

Emerging markets in Asia-Pacific and Latin America offer significant growth potential due to their increasing adoption of advanced cancer treatments and improving healthcare infrastructure[3].

Key Takeaways

• The Jevtana market is driven by the increasing incidence of prostate cancer, advancements in oncology treatments, and rising demand for effective therapies for mCRPC.
• The market is expected to grow at a CAGR of 7-9% over the next several years.
• Key players include Sanofi, Tapi Teva, Fuan Pharmaceutical Group, and Fujian Yewpark Biological.
• Emerging markets and innovations in personalized medicine are significant growth drivers.
• Despite growth, the market faces challenges such as adverse effects and competition.

FAQs

1. What is Jevtana used for? Jevtana (cabazitaxel) is used for the treatment of metastatic castration-resistant prostate cancer (mCRPC), particularly as a second-line treatment following the failure of hormone therapy[1][3].

2. Who are the main players in the Jevtana market? The main players in the Jevtana market include Sanofi, Tapi Teva, Fuan Pharmaceutical Group, and Fujian Yewpark Biological[1][4].

3. What are the key drivers of the Jevtana market growth? The key drivers include the rising incidence of prostate cancer, advancements in oncology treatments, and the increasing adoption of advanced therapies in emerging markets[3].

4. How effective is Jevtana in treating prostate cancer? Jevtana has proven to be highly effective in treating patients with advanced prostate cancer, particularly those who have become resistant to other treatments. It improves overall survival rates and delays disease progression[3].

5. What are the potential investment opportunities in the Jevtana market? Investment opportunities include pharmaceutical companies involved in oncology research, R&D investments in cancer therapies, and partnerships focusing on innovative drug combinations, especially in emerging markets[3].

Cited Sources:

1. The Insight Partners. Global Jevtana Market Dynamics 2021-2031.
2. Tokai Pharmaceuticals, Inc. Consolidated Statements of Operations and Comprehensive Loss.
3. Market Research Intellect. Innovative Therapies Fuel Growth in the Jevtana Market for Prostate Cancer.
4. Valuates Reports. Global Jevtana Market Research Report 2024.
5. Sanofi. Annual Report on Form 20-F 2023.