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:	1
Clinical Trials:	54
Patent Applications:	5,762
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
Prospect Creek Foundation	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
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010	AP	RX	Yes	Yes					Y
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010	AP	RX	Yes	Yes
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010	AP	RX	Yes	Yes					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
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010

EU/EMA Drug Approvals for JEVTANA KIT

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/005178Treatment 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/002018Jevtana 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/004951Treatment of prostate cancer	Refused	no	no	no		2019-07-11

International Patents for JEVTANA KIT

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

Country	Patent Number	Title	Estimated Expiration
Portugal	1667986
Romania	115877
Japan	3689791
China	1849311	Acetone solvate of dimethoxy docetaxel and its process of preparation
Morocco	28045	SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL ET SON PROCEDE DE PREPARATION
Taiwan	I654975

Supplementary Protection Certificates for JEVTANA KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1667986	122013000050	Germany		PRODUCT NAME: ACETON-SOLVAT VON CABAZITAXEL; 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)
1667986	1390025-3	Sweden		PRODUCT NAME: CABAZITAXEL ACETONSOLVAT; REG. NO/DATE: EU/1/11/676/001 20110317
1667986	CA 2013 00025	Denmark
1667986	28/2013	Austria		PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986	13C0037	France		PRODUCT NAME: CABAZITAXEL SOUS FORME ACETONATE (OU SOLVAT ACETONIQUE DU CABAZITAXEL); REGISTRATION NO/DATE: EU/1/11/676/001 20110322

Market Dynamics and Financial Trajectory for JEVTANA KIT

Last updated: August 5, 2025

Introduction

JEVTANA KIT (cabazitaxel) is a chemotherapy medication prescribed primarily for the treatment of metastatic castration-resistant prostate cancer (mCRPC). As an integral component of advanced oncology therapies, its market dynamics are shaped by factors including clinical efficacy, regulatory approvals, competition, and pricing strategies. This analysis expounds on the current market landscape, financial trends, and future outlook for JEVTANA KIT, delivering insights essential to pharmaceutical stakeholders, investors, and healthcare providers.

Overview of JEVTANA KIT

JEVTANA KIT, developed by Sanofi, combines cabazitaxel with supportive premedication and supplies that facilitate administration. It was approved by the U.S. Food and Drug Administration (FDA) in 2010 for patients with metastatic castration-resistant prostate cancer previously treated with docetaxel. Its mechanism involves inhibition of microtubule disassembly, leading to apoptosis in cancer cells. The drug’s predefined indications, dosage, and administration protocols influence its market implementation.

Market Landscape and Dynamics

Growing Incidence of Prostate Cancer

The global burden of prostate cancer significantly influences JEVTANA’s market. According to the American Cancer Society, approximately 268,490 new prostate cancer cases are diagnosed annually in the U.S. alone, with rising numbers projected globally due to aging populations and improved diagnostic techniques (1). This increasing prevalence fuels the demand for effective second-line chemotherapeutic options like cabazitaxel.

Therapeutic Positioning and Clinical Efficacy

JEVTANA KIT is positioned as a second-line treatment after docetaxel failure, demonstrating survival benefits. Clinical trials, notably the TROPIC study, confirmed its efficacy, showing a median overall survival advantage of 2.4 months over mitoxantrone (2). Such data underpin clinician confidence and bolster prescribing rates, especially amidst evolving standards favoring novel combination therapies.

Regulatory Milestones and Market Access

Regulatory approvals across key markets—US, Europe, Japan—have expanded JEVTANA’s availability. The US FDA approval was supported by pivotal trials showing survival benefits and manageable safety profiles. Similarly, European Medicines Agency (EMA) approval in 2014 opened pathways into European markets, where prostate cancer prevalence mirrors global trends. However, access and reimbursement policies considerably impact sales, requiring strategic engagement with national health authorities.

Competitive Landscape

JEVTANA faces competition from novel androgen receptor inhibitors (e.g., enzalutamide, abiraterone), which have shown survival benefits in mCRPC with oral administration and differing safety profiles. Additionally, other chemotherapeutic agents and immunotherapies are emerging, capitalizing on combination strategies. Nonetheless, cabazitaxel maintains relevance due to its validated efficacy post-docetaxel therapy, particularly where targeted therapies are contraindicated or ineffective.

Pricing and Reimbursement

Pricing strategies and reimbursement policies dominate JEVTANA’s financial trajectory. As an oncology injectable, it commands premium pricing, supported by proven clinical benefits. However, payer scrutiny over high drug costs necessitates value-based pricing models. The introduction of biosimilars or generic formulations could influence pricing, but currently, no biosimilar exists for cabazitaxel globally, maintaining its premium status.

Market Penetration and Adoption Drivers

Factors promoting adoption include physician familiarity, clinical guidelines endorsement, and patient access to infusion centers. Training healthcare providers and integrating JEVTANA into standard treatment algorithms bolster sales. Conversely, safety concerns such as neutropenia, diarrhea, and hypersensitivity reactions may temper utilization rates and necessitate comprehensive management protocols.

Financial Trajectory and Revenue Trends

Historical Revenue Performance

Following its approval, JEVTANA exhibited steady revenue growth. In 2020, Sanofi reported approximately €330 million in global sales of cabazitaxel-based formulations, reflecting strong market uptake in the US, Europe, and select Asian markets (3). Steady expansion emanates from increased institutional adoption and awareness campaigns.

Market Growth Projections

Industry analysts forecast compound annual growth rates (CAGR) of 4-6% over the next five years, driven by rising prostate cancer prevalence and improved treatment pathways. Moreover, expanded indications—such as hormone-sensitive prostate cancer in combination regimens—may further augment revenue streams.

Impact of Market Expansion and Convergence with Combinations

Emerging data suggest potential approval for combination therapies, such as cabazitaxel with androgen receptor signaling inhibitors, potentially elevating sales. Additionally, geographic expansion into Latin America, the Middle East, and Southeast Asia presents growth opportunities, contingent on local regulatory and reimbursement environments.

Potential Challenges and Risks

Factors threatening revenue include patent expiration, biosimilar emergence, and stringent cost-containment policies. Safety profile concerns may also affect prescribing patterns. Moreover, novel therapeutics with superior efficacy or convenience could erode market share.

Future Outlook

Innovation and Pipeline Developments

Sanofi is investing in research to optimize cabazitaxel formulations, including nanoparticle delivery systems to improve pharmacokinetics and reduce toxicity. Additionally, ongoing trials examine its use in earlier stages of prostate cancer and combination therapies, promising a broader therapeutic landscape.

Regulatory and Market Dynamics

Anticipated regulatory approvals for combination regimens endorsed by clinical guidelines are poised to cement JEVTANA’s position. Market access strategies focusing on health economics and patient outcomes will be pivotal. Moreover, competition from immunotherapies and precision medicine approaches may redefine treatment paradigms, potentially impacting long-term revenues.

Strategic Recommendations

Stakeholders should focus on clinical validation of new indications, cost-effectiveness demonstration, and partnership development to sustain growth. Differentiation through safety profile improvements and patient-centric dosing regimens can enhance market penetration.

Key Takeaways

• The increasing incidence of prostate cancer, combined with its positioning as a second-line therapy, sustains JEVTANA KIT’s market demand.
• Clinical efficacy and regulatory approvals across key regions underpin its market presence authority.
• Competitive pressures from emerging therapies and biosimilars pose long-term challenges; however, current barriers to entry for biosimilars help maintain premium pricing.
• Revenue growth is expected to continue, supported by geographic expansion and potential new combination indications.
• Strategic engagement with payers, ongoing clinical development, and innovation are essential to optimize JEVTANA’s financial trajectory.

FAQs

1. How does JEVTANA KIT differentiate itself from other prostate cancer treatments?
JEVTANA KIT is specifically indicated for metastatic castration-resistant prostate cancer post-docetaxel therapy, with demonstrated survival benefits. Its injectable formulation targets patients with limited options after initial chemotherapy failure, offering a proven, effective second-line chemotherapeutic option distinguished by its clinical efficacy.

2. What factors influence the pricing and reimbursement of JEVTANA KIT?
Pricing is driven by clinical value, manufacturing costs, regulatory approvals, and market competition. Reimbursement depends on health technology assessments, payer policies, and cost-effectiveness evaluations, which vary across regions. Innovative pricing models and demonstrating economic benefits are critical to healthcare access.

3. Are there emerging therapies that threaten JEVTANA’s market dominance?
Yes. Oral androgen receptor inhibitors such as enzalutamide and abiraterone, along with immunotherapies, are evolving treatment algorithms. However, JEVTANA remains relevant as a validated chemotherapy option, especially post-docetaxel, pending further integration of combination regimens.

4. What opportunities exist for growth in developing markets?
Expanding access through strategic partnerships with local distributors, regulatory agencies, and payer negotiations offers growth opportunities. Addressing unmet needs in underserved populations and adapting to local healthcare infrastructure can accelerate market penetration.

5. What are the key risks associated with JEVTANA KIT’s long-term market viability?
Patent expirations, biosimilar entry, safety concerns, and the advent of superior therapies pose risks. Additionally, shifts in treatment guidelines favoring targeted or immuno-oncology approaches could diminish its market share unless strategic innovation and pipeline expansion occur.

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Sources:

1. American Cancer Society. Prostate Cancer Facts & Figures 2022.
2. de Bono JS, et al. Cabazitaxel versus mitoxantrone in metastatic castration-resistant prostate cancer: TROPIC trial. Lancet. 2010;376(9742): 98-107.
3. Sanofi Annual Report 2020.