JEVTANA KIT Drug Patent Profile

« Back to Dashboard

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 five patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in JEVTANA KIT is cabazitaxel. There is one drug master file entry 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

US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	54
Patent Applications:	5,248
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
OHSU Knight Cancer Institute	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 five 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					Y
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					Y
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					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

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
Argentina	078824
Australia	2010310986
Australia	2015200149
Australia	2016200598
Australia	2017232227
Australia	2019203514
Brazil	112012011457

Supplementary Protection Certificates for JEVTANA KIT

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	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	CA 2013 00025	Denmark
1667986	PA2013010	Lithuania		PRODUCT NAME: CABAZITAXELUM; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986	C300595	Netherlands		PRODUCT NAME: CABAZITAXEL ACETONAAT; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986	122013000050	Germany		PRODUCT NAME: ACETON-SOLVAT VON CABAZITAXEL; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986	C20130017 00077	Estonia		PRODUCT NAME: KABASITAKSEEL;REG NO/DATE: K(2011)1888 LOPLIK 17.03.2011

Last updated: July 27, 2026

Market dynamics and financial trajectory for Jevtana Kit (cabazitaxel) in the US and key ex-US markets

Jevtana Kit (cabazitaxel, Sanofi) remains a high-value oncology drug with a concentrated patient base in metastatic castration-resistant prostate cancer (mCRPC). Financial trajectory is shaped by (1) the competitive shift from cabazitaxel to newer mCRPC regimens (notably AR pathway agents and sequencing changes), (2) payer pressure on high-cost chemotherapy, and (3) patent-driven supply and channel stability in the US. Outside the US, the commercial profile tracks earlier cycle decline and localized generic/biosimilar-adjacent risks, with the largest revenue exposure concentrated in the US and Western Europe.

Core commercial driver: cabazitaxel is used in specific mCRPC lines after docetaxel, with institutional uptake tied to guideline adherence and reimbursement coverage.

---

What is Jevtana Kit (cabazitaxel) and how is it used in mCRPC?

Jevtana Kit is a branded formulation and kit product of cabazitaxel for systemic chemotherapy.

What indications drive demand?

Cabazitaxel use is anchored in mCRPC settings where the sequencing logic places it after docetaxel exposure. Demand depends on:

• docetaxel penetration and duration of first-line mCRPC regimens
• adoption of earlier “triplet” strategies that shorten the time patients reach later-line chemotherapy
• clinician practice patterns by site of care (community vs academic)

What product characteristics matter commercially?

• administration requires specialized oncology pharmacy workflows and supportive care (notably to manage neutropenia risk)
• kit-based supply affects distributor ordering patterns and service-level performance
• dose intensity and regimen design influence patient counts and average sales per treated patient

---

How has Jevtana Kit market share moved versus competing mCRPC regimens?

Jevtana’s competitive position is most sensitive to sequencing against:

• AR-pathway agents (abiraterone, enzalutamide, etc.) used earlier in the disease course
• other later-line chemotherapies and targeted options adopted by national formularies
• radiopharmaceutical and combination strategies that redirect patient pathways away from later chemotherapy

Competitive pressure mechanisms that typically hit cabazitaxel

• line-of-therapy timing: as mCRPC evolves with earlier potent agents, the fraction of patients reaching cabazitaxel later-line chemotherapy can fall
• payers and formularies: high-cost chemotherapy faces step edits, prior authorization, and restricted coverage
• clinical preference by subgroup: performance status and comorbidity criteria reduce eligible patient pool versus headline incidence

Revenue consequence for a branded oncology chemotherapy like Jevtana

• even stable per-patient uptake can be offset by reduced later-line volumes
• net sales trajectory often depends more on treated-patient count and patient mix than on net pricing alone

---

When does Jevtana Kit face generic or biosimilar entry risk in the US?

Jevtana is a small-molecule chemotherapy. Biosimilar risk is not the relevant category; the main risk is generic small-molecule entry (ANDA) once Orange Book protections and exclusivities expire and/or after any Paragraph IV challenges.

A complete generic risk assessment requires Orange Book listings and litigation records tied to specific Jevtana NDCs. Without those listings and case dockets, an accurate “when” and “how likely” cannot be produced.

---

What patents protect Jevtana Kit (cabazitaxel) and how does the patent estate affect financial trajectory?

Cabazitaxel “kit” commercial sustainability in the US depends on:

• composition-of-matter protections
• formulation and method-of-use claims
• regulatory exclusivities that can delay approval of competing products for specific carve-outs

A complete patent-coverage map requires Jevtana’s specific Orange Book patents (by NDC, patent number, assignee, and expiration) and any Hatch-Waxman litigation history. Without those Orange Book and docket facts, the strength and timing of protection cannot be stated precisely.

---

How strong is Jevtana Kit’s Orange Book status and listing coverage?

Orange Book status is determinative for time-to-competition in the US. Key factors are:

• number of listed patents per NDC
• scope of claims (drug substance vs formulation vs method of use)
• any pediatric exclusivity or other exclusivity periods affecting specific approvals

A reliable Orange Book status summary requires direct extraction of Jevtana’s NDC-level listings and their expiration dates, which are not provided in the current prompt.

---

What is the FDA regulatory pathway impact on Jevtana Kit revenue stability?

Because Jevtana is already marketed, the principal FDA pathway impact on revenue is:

• how competing products gain approval pathways under Hatch-Waxman (ANDA route timing)
• whether label scope remains stable (indication breadth affects payer coverage and clinician use)

A full regulatory timeline requires Jevtana’s current FDA-approved label details by indication and any recent label changes. Those facts are not included here.

---

What generic entry risks exist for Jevtana Kit and how would they affect unit sales?

Generic entry in chemotherapy tends to cause:

• rapid market share shift when formulary coverage switches
• pricing compression and margin erosion on a branded base
• stocking and channel adjustments in oncology specialty distribution networks

For Jevtana specifically, generic entry risk hinges on whether ANDA challengers can:

• obtain FDA approval promptly at the earliest legal date
• launch at scale with adequate supply
• pass bioequivalence and manufacturing inspection requirements for the kit presentation

A precise generic-launch scenario requires NDC-specific Orange Book expiration dates, any Paragraph IV settlements, and court rulings, none of which are provided.

---

How do payer dynamics and reimbursement constraints shape Jevtana Kit net pricing?

Net pricing trajectory for branded oncology chemotherapy depends on:

• hospital and group purchasing organization (GPO) contracting cycles
• Medicaid/Medicare Part D reimbursement mechanics and utilization management
• prior authorization and step therapy practices that restrict access
• patient-level co-pay support availability and payer steering

Common pattern for high-cost branded injectables:

• gross-to-net declines when payers tighten controls
• price holds only when clinical differentiation and guideline positioning remain strong

For Jevtana, reimbursement sensitivity is amplified by the need for supportive care and the cadence of administration schedules, which influences total episode cost.

---

How do manufacturing and supply chain dynamics affect Jevtana Kit sales?

Oncology kit products can experience revenue shocks from:

• oncology specialty distributor allocation during constrained supply
• procurement lead times tied to sterile manufacturing capacity
• component availability constraints (kit packaging) and cold-chain or storage requirements where applicable

In stable regimes, supply consistency supports steady hospital ordering. In constrained regimes, allocation can temporarily cap unit sales even when clinical demand exists.

A confirmed Jevtana-specific supply event schedule requires operational and press-release data, which is not provided.

---

What financial trajectory has Jevtana Kit shown and what line items typically move?

For branded oncology drugs, the two main financial levers are:

1. Net sales driven by treated patient volume and net price
2. Commercial profitability influenced by net price offsets, rebates, and specialty-channel costs

A “financial trajectory” analysis requires actual historical net sales and segment reporting (Sanofi disclosures by product, region, and year) plus revenue mix by geography and formulation. None of those financial figures are included in the prompt, so a quantified trajectory cannot be produced.

---

Which geographies contribute most to Jevtana Kit revenue exposure?

Revenue exposure for mature branded oncology drugs typically concentrates in:

• the US (largest reimbursement scale and strict channel management)
• major EU markets (Germany, France, UK, Italy) depending on uptake and tender systems
• Japan and selected ex-US countries where prescribing and access policies support chemotherapy availability

A precise revenue exposure map for Jevtana requires region-level sales data.

---

How does Jevtana compare with key mCRPC chemotherapy and later-line oncology competitors?

Market dynamics for cabazitaxel are best interpreted against alternatives used in similar later-line windows:

• docetaxel failures leading to cabazitaxel switching
• sequencing versus AR-targeted agents and other later-line systemic therapies

A rigorous comparison requires:

• sales history by competitor
• label overlap by line of therapy
• pricing and formulary access metrics

Those competitor-specific financial data are not provided.

---

Key Takeaways

• Jevtana Kit (cabazitaxel) commercial performance is primarily determined by mCRPC sequencing depth, later-line chemotherapy volumes, and payer restrictions on high-cost chemotherapy.
• Market share is vulnerable when newer mCRPC regimens shift patients away from later-line cabazitaxel use, even if per-patient treatment remains stable.
• The decisive US timing for competitive erosion is set by Orange Book patent coverage and Hatch-Waxman litigation outcomes tied to specific Jevtana NDCs, which are required for a precise “when” view.
• Quantified financial trajectory (historical net sales, gross-to-net changes, and geographic mix) cannot be stated from the provided prompt; it requires product-level and region-level financial disclosures.

---

FAQs

1) What is Jevtana Kit’s typical line-of-therapy placement in mCRPC treatment sequences?
After docetaxel in metastatic castration-resistant prostate cancer, with utilization dependent on guideline adherence, patient performance status, and reimbursement access.

2) Does Jevtana face biosimilar competition?
No. Cabazitaxel is a small-molecule chemotherapy, so the main competitive mechanism is generic small-molecule entry, not a biosimilar pathway.

3) What payer tools most affect Jevtana net sales?
Prior authorization, step edits, formulary tier placement, and rebate structures tied to utilization management.

4) What variables most influence Jevtana unit demand?
The size of the mCRPC population reaching post-docetaxel later lines, regimen sequencing decisions, and institutional chemotherapy pathway protocols.

5) What data sources are needed to model Jevtana’s US exclusivity and launch risk?
Orange Book NDC-level patent listings, FDA approval history, and any Paragraph IV filings or court dockets tied to Jevtana’s specific patents and settlements.

---

References

1. FDA Orange Book. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. US FDA. (n.d.). Drugs@FDA. U.S. Food and Drug Administration.
3. Federal Register / Hatch-Waxman framework. (n.d.). 21 U.S.C. 355 and associated exclusivity and patent dispute provisions. U.S. Government.