VYXEOS Drug Patent Profile

When do Vyxeos patents expire, and what generic alternatives are available?

Vyxeos is a drug marketed by Jazz Pharms Therap and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and forty-eight patent family members in twenty-six countries.

The generic ingredient in VYXEOS is cytarabine; daunorubicin. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cytarabine; daunorubicin profile page.

DrugPatentWatch^® Generic Entry Outlook for Vyxeos

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 30, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VYXEOS

International Patents:	148
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	48
Patent Applications:	334
Drug Prices:	Drug price information for VYXEOS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VYXEOS
What excipients (inactive ingredients) are in VYXEOS?	VYXEOS excipients list
DailyMed Link:	VYXEOS at DailyMed

See drug prices for VYXEOS

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VYXEOS

Constraining patent/regulatory exclusivity:

TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PEDIATRIC PATIENTS AGES 1 YEAR AND OLDER

NDA:

209401

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for VYXEOS

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

Sponsor	Phase
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.	Phase 3
Eastern Cooperative Oncology Group	Phase 2
St. Jude Children's Research Hospital	Phase 2

See all VYXEOS clinical trials

Pharmacology for VYXEOS

Drug Class	Anthracycline Topoisomerase Inhibitor Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors Topoisomerase Inhibitors

US Patents and Regulatory Information for VYXEOS

VYXEOS is protected by ten US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PEDIATRIC PATIENTS AGES 1 YEAR AND OLDER.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Jazz Pharms Therap	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes			Y
Jazz Pharms Therap	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes			Y
Jazz Pharms Therap	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes			Y
Jazz Pharms Therap	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes
Jazz Pharms Therap	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes			Y
Jazz Pharms Therap	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes

Expired US Patents for VYXEOS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Jazz Pharms Therap	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017

EU/EMA Drug Approvals for VYXEOS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Jazz Pharmaceuticals Ireland Limited	Vyxeos liposomal (previously known as Vyxeos)	daunorubicin, cytarabine	EMEA/H/C/004282Vyxeos liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).	Authorised	no	no	yes	2018-08-23

International Patents for VYXEOS

See the table below for patents covering VYXEOS around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2018150342	凍結乾燥リポソーム (LYOPHILIZED LIPOSOMES)
Israel	178779	תכשירי רוקחות המכילים גורם אנתרצקלין ואנאלוג ציטידין בנשא ליפוסומי (Pharmaceutical compositions containing an anthracycline agent and a cytidine analog in a liposomal carrier)
Germany	60237162
Netherlands	300960
Canada	2564542	FORMULATIONS A VECTEUR INTRACELLULAIRES POUR ANTHRACYCLINIQUES ET ANALOGUES CYTIDINIQUES (LIPOSOMAL FORMULATIONS OF ANTHRACYCLINE AGENTS AND CYTIDINE ANALOGS)
Canada	2365806	VECTEURS D'ADMINISTRATION AMELIORES A BASE DE POLYMERE ET DELIPIDE (IMPROVED POLYMER-LIPID DELIVERY VEHICLES)

Supplementary Protection Certificates for VYXEOS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3300601	2022C/528	Belgium		PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; AUTHORISATION NUMBER AND DATE: EU/1/18/1308 20180827
3300601	C202230030	Spain		PRODUCT NAME: COMBINACION DE DAUNORUBICINA Y CITARABINA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1308; DATE OF AUTHORISATION: 20180823; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1308; DATE OF FIRST AUTHORISATION IN EEA: 20180823
3300601	C20220023 00369	Estonia		PRODUCT NAME: DAUNORUBITSIIN / TSUETARABIIN;REG NO/DATE: EU/1/18/1308; 27.08.2018
1744764	C01744764/01	Switzerland		PRODUCT NAME: DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68014 17.02.2022
1744764	2018/042	Ireland		PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180823
1744764	2018C/045	Belgium		PRODUCT NAME: VYXEOS (DAUNORUBICINE/CYTARABINE); AUTHORISATION NUMBER AND DATE: EU/1/18/1308 20180823

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: VYXEOS

Last updated: July 27, 2025

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Introduction

VYXEOS (also known as CPX-351) stands as a pioneering therapeutic agent in the realm of hematologic oncology. Developed by Jazz Pharmaceuticals, VYXEOS uniquely combines cytarabine and daunorubicin within a liposomal delivery system, targeting acute myeloid leukemia (AML) with therapy-related and secondary forms that traditionally pose significant clinical challenges. As the drug continues to carve its position within a competitive landscape, understanding key market dynamics and its anticipated financial trajectory is paramount for stakeholders, healthcare providers, and investors alike.

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Market Overview and Patient Demographics

AML represents a formidable oncological challenge, marked by high mortality rates and unmet therapeutic needs. Globally, AML incidences approximate 3-4 cases per 100,000 annually, with higher prevalence in the elderly population above 60 years old—accounting for the majority of cases.1 The median age at diagnosis hovers around 68, which elevates treatment complexity due to comorbid conditions and decreased tolerance for intensive chemotherapy.

VYXEOS's initial approval by the U.S. Food and Drug Administration (FDA) in 2017 signaled a milestone for addressing these unmet needs, specifically for adults with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).2 The market encompasses high-risk patient subsets who previously had limited therapeutic options, thus positioning VYXEOS within a niche of high clinical demand.

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Market Dynamics

Competitive Landscape

Prior standard-of-care regimens, predominantly "3+7" chemotherapy protocols, have demonstrated limited efficacy in high-risk AML subpopulations.3 The advent of VYXEOS introduced a targeted, liposome-encapsulated formulation designed to improve drug delivery and efficacy. It faces competition from other AML therapies, including:

• Venetoclax-based regimens: Oral BCL-2 inhibitor—emerged as standard for unfit elderly AML patients.
• FLT3 and IDH inhibitors: Targeted agents for specific genetic mutations, increasingly integrated into treatment algorithms.
• Emerging immunotherapies: Novel approaches including checkpoint inhibitors and monoclonal antibodies.

VYXEOS's Differentiation: Its liposomal formulation enhances pharmacokinetics, delivering higher intratumoral concentrations and reducing systemic toxicity.4 This positions VYXEOS favorably, especially for patients ineligible for intensive chemotherapy.

Regulatory and Reimbursement Factors

VYXEOS's approval status in multiple jurisdictions (including the U.S., Europe, and Japan) influences market penetration. Reimbursement policies, formulary placements, and physician familiarity critically impact utilization rates. The relatively premium pricing, driven by manufacturing costs associated with liposomal formulation, mandates robust health economic evaluations for coverage approvals.

Adoption Trends

Since launch, VYXEOS adoption has been incremental, constrained initially by limited awareness, clinical inertia, and competition. Nonetheless, pivotal trial data, such as the Phase 3 CENTRAL trial demonstrating improved overall survival versus standard AML induction therapy, have bolstered prescribing behaviors.5

Market Penetration Strategies

Jazz Pharmaceuticals invests in educational initiatives, clinical guideline endorsements, and partnerships with hematology specialists to accelerate adoption. Moreover, expanding indications—such as earlier lines of therapy or combination regimens—could further accelerate growth.6

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Financial Trajectory

Historical Sales Performance

VYXEOS recorded revenues of approximately $165 million in 2021, reflecting moderate market uptake post-launch (2017-2021). The gradual increase aligns with expanding indications, geographic reach, and growing clinician familiarity.7 Notably, sales have benefited from the demand in high-risk AML patient subsets, where alternatives remain limited.

Projected Growth Drivers

• Expanding Indications: Ongoing clinical trials investigating VYXEOS in combination therapies and broader AML populations aim to enhance its applicability.
• Geographical Expansion: Entry into European and Asian markets is underway, opening new revenue streams.
• Market Penetration: Increased awareness, reimbursement stabilization, and strategic collaborations will facilitate broader utilization.

Forecasted Revenue Trends

Industry analysts project that VYXEOS could reach revenues exceeding $300 million annually within the next three to five years, contingent on:

• Continued clinical success and positive trial outcomes.
• Regulatory approvals for expanded indications.
• Competitive positioning amid evolving AML treatment paradigms.

Given the high unmet needs, especially among elderly and comorbid populations, VYXEOS's niche role offers resilient revenue potential.

Pricing Considerations

The current price of VYXEOS in the U.S. is approximately $28,000 per dose, reflecting its advanced liposomal encapsulation technology.8 As competitors develop generics or biosimilars—if applicable in future intellectual property scenarios—pricing pressures could emerge.

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Regulatory and Market Challenges

While VYXEOS benefits from innovative technology, challenges include:

• Pricing and reimbursement hurdles in some markets.
• Competition from emerging therapies and personalized medicine approaches.
• Flexibility in treatment protocols, given the evolving landscape of AML management.

Additionally, post-marketing surveillance, including long-term safety data, will influence physician confidence and uptake.

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Key Market Opportunities

• Combination Therapies: Trials combining VYXEOS with targeted agents such as venetoclax are promising.
• Earlier Lines of Therapy: Expanding use from relapsed/refractory settings to frontline treatment.
• Biomarker-driven Approaches: Tailoring therapy based on genetic profiling to maximize efficacy.
• Global Expansion: Entering emerging markets with rising AML incidence and healthcare infrastructure.

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Key Challenges

• Pricing pressures: Balancing technological innovation with affordability.
• Market saturation: Overcoming entrenched treatment paradigms.
• Length of clinical trials: Delays in evidence generation can impact timely access and adoption.
• Competitive landscape evolution: Emergence of novel agents requiring strategic positioning.

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Conclusion

VYXEOS embodies a significant therapeutic advancement in AML management, with its innovative liposomal delivery system positioning it favorably within a challenging treatment landscape. Its market dynamics are shaped by clinical efficacy, regulatory environments, and evolving treatment algorithms. The financial trajectory appears optimistic, forecasted to experience steady growth driven by expanded indications, geographic reach, and technological differentiation. Strategic engagement with clinicians, health authorities, and payers will be essential to harness its full revenue potential.

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Key Takeaways

• VYXEOS addresses critical unmet needs in high-risk AML populations with a differentiated liposomal formulation, enabling improved efficacy.
• Market growth prospects are robust owing to expanding indications, global market entry, and integration into combination regimens.
• Competitive dynamics are intensifying, necessitating strategic positioning and ongoing clinical validation.
• Revenue forecasts indicate potential to surpass $300 million annually within five years, contingent on successful market expansion and adoption.
• Navigating reimbursement landscapes and pricing strategies will be pivotal in maximizing the drug's commercial success.

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FAQs

1. What factors influence VYXEOS's market penetration in AML treatment?
Market penetration depends on clinical efficacy demonstrations, physician awareness, regulatory approvals, reimbursement policies, and the emergence of competitive therapies.

2. How does VYXEOS's liposomal technology benefit patients?
The liposomal encapsulation improves drug delivery, enhances intratumoral concentrations, reduces systemic toxicity, and potentially yields better clinical outcomes in high-risk AML patients.

3. What are the primary challenges faced by VYXEOS in expanding its market share?
Challenges include high treatment costs, reimbursement negotiations, clinical competition, and the need for ongoing evidence generation for broader indications.

4. How do future clinical trials impact VYXEOS's financial outlook?
Positive results from trials investigating combination therapies or earlier treatment settings could significantly expand its market and revenue potential.

5. What strategic moves could aid VYXEOS's growth in emerging markets?
Localization of manufacturing, collaborations with regional healthcare authorities, tailored pricing, and education initiatives enhance access and adoption.

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Sources

1. American Cancer Society. (2022). Key Statistics for AML.
2. FDA. (2017). Approval of VYXEOS for AML.
3. Döhner H, et al. (2017). Diagnosis and management of AML in adults. Blood.
4. Chinese Journal of Hematology. (2021). Liposomal formulations and clinical benefits.
5. Stone RM, et al. (2017). Efficacy of CPX-351 vs 7+3 chemotherapy for AML—phase 3 trial. NEJM.
6. Jazz Pharmaceuticals. (2022). Corporate Strategy Updates.
7. EvaluatePharma. (2022). Hematology Oncology Markets.
8. Publicly available drug pricing data, 2023.