Cytarabine; daunorubicin - Generic Drug Details

What are the generic drug sources for cytarabine; daunorubicin and what is the scope of freedom to operate?

Cytarabine; daunorubicin is the generic ingredient in one branded drug marketed by Jazz Pharms Therap and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cytarabine; daunorubicin has one hundred and forty-eight patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for cytarabine; daunorubicin

International Patents:	148
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	305
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cytarabine; daunorubicin
DailyMed Link:	cytarabine; daunorubicin at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cytarabine; daunorubicin

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

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 cytarabine; daunorubicin

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

Sponsor	Phase
Children's Oncology Group	PHASE2
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.	PHASE2
M.D. Anderson Cancer Center	PHASE1

See all cytarabine; daunorubicin clinical trials

Pharmacology for cytarabine; daunorubicin

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

Anatomical Therapeutic Chemical (ATC) Classes for cytarabine; daunorubicin

L01BC	Pyrimidine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L01DB	Anthracyclines and related substances
L01D	CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L01XY	Combinations of antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for cytarabine; daunorubicin

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	10,166,184		Y
Jazz Pharms Therap	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes	7,850,990		Y
Jazz Pharms Therap	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes	8,518,437		Y
Jazz Pharms Therap	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes	10,835,492

Expired US Patents for cytarabine; daunorubicin

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	8,431,806

EU/EMA Drug Approvals for cytarabine; daunorubicin

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 cytarabine; daunorubicin

Country	Patent Number	Title	Estimated Expiration
Japan	2017160211
Russian Federation	2014120475	ЛИОФИЛИЗИРОВАННЫЕ ЛИПОСОМЫ
Japan	4972545
World Intellectual Property Organization (WIPO)	03028697

Supplementary Protection Certificates for cytarabine; daunorubicin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2768484	301016	Netherlands		PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; REGISTRATION NO/DATE: NOT AVAILABLE
1744764	SPC/GB18/045	United Kingdom		PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTERED: UK EU/1/18/1308/001-003 20180827; UK PLGB 31626/0004 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
1744764	300960	Netherlands		PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827

Market Dynamics and Financial Trajectory for Cytarabine and Daunorubicin

Last updated: July 28, 2025

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Introduction

The pharmaceutical landscape for cytarabine and daunorubicin, two cornerstone agents in oncotherapy, particularly in acute myeloid leukemia (AML), continues to evolve amid shifting market dynamics, regulatory developments, and scientific innovations. While these agents have established roles, their commercial and clinical trajectories are influenced by factors including patent status, biosimilar emergence, therapeutic alternatives, and global healthcare trends. This analysis explores current market forces and future financial prospects for cytarabine and daunorubicin.

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Pharmaceutical Profile and Clinical Significance

Cytarabine (Ara-C) is a nucleoside analog primarily used in the treatment of AML and other hematologic malignancies. Since its inception in the 1960s, it has remained a critical component of induction and consolidation chemotherapy schemes [1].

Daunorubicin, an anthracycline antibiotic, is integral to AML induction therapy, often combined with cytarabine to improve remission rates [2].

Their efficacy, established safety profiles, and generic availability have cemented their position in AML treatment protocols, though newer agents continuously challenge their dominance.

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Market Dynamics

1. Patent Status and Market Entry of Generics and Biosimilars

Patent protection for original formulations of cytarabine and daunorubicin has long expired, resulting in widespread generic manufacturing. This significantly depresses drug prices and constricts revenue streams for original developers. For instance, Teva, Fresenius, and other generic manufacturers dominate the market, offering affordable alternatives globally [3].

Biosimilar development is less pertinent to these agents, given their small-molecule or nucleotide-based nature. However, concerns regarding manufacturing consistency and regulatory pathways influence market competition.

2. Therapeutic Advancements and Alternative Agents

Recent developments in AML therapy introduce targeted therapies like FLT3 inhibitors (e.g., midostaurin) and BCL-2 inhibitors (e.g., venetoclax), which sometimes reduce reliance on traditional cytarabine and daunorubicin regimens, particularly in specific patient subgroups [4].

Moreover, targeted therapies and immunotherapies are pushing the treatment paradigm toward personalized medicine, potentially diminishing the overall market size for traditional chemotherapeutics.

3. Regulatory and Reimbursement Factors

Regulatory agencies, such as the FDA and EMA, continue to approve optimized formulations, including liposomal variants of daunorubicin and cytarabine, which demonstrate improved efficacy and safety profiles [5].

In parallel, reimbursement policies and pricing pressures, especially in the US and Europe, influence market accessibility and sales volumes, contributing to a highly competitive pricing environment.

4. Global Market Expansion and Demographic Trends

The persistent global burden of AML, especially among aging populations, sustains demand in emerging markets. Countries like China, India, and Brazil exhibit growing oncology markets, although affordability and infrastructural challenges limit access to novel therapies [6].

Economic growth in these regions favors increased procurement and utilization of generic chemotherapeutics, maintaining steady sales.

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Financial Trajectory

1. Revenue Trends and Market Size

The global AML therapeutics market is projected to reach approximately USD 2.5 billion by 2027, driven mainly by targeted therapy growth, yet traditional chemotherapeutics like cytarabine and daunorubicin constitute substantial fractions—estimated at USD 600-800 million currently [7].

A decline in sales of these agents is anticipated over the next decade due to the gradual shift toward targeted treatments, but steady demand persists owing to affordability and existing clinical protocols.

2. Impact of Drug Pricing and Volume

Given the widespread availability of generics, per-unit prices for cytarabine and daunorubicin remain low. Revenue growth relies largely on increased volume rather than price escalation.

Market analysts suggest that upcoming biosimilar and generic entrants could further suppress pricing, making innovation in delivery forms (e.g., liposomal variants) critical for maintaining margins.

3. R&D and Pipeline Considerations

Current investments in R&D for these agents focus on improving bioavailability, reducing toxicity, and combining with novel agents to extend therapeutic benefit. The development of formulation innovations, such as liposomal delivery systems (e.g., Vyxeos for AML), has demonstrated significant clinical and commercial success—highlighting a potential avenue for revenue sustainability [8].

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Market Challenges and Opportunities

Challenges:

• Anticipated decline in market share due to emerging targeted therapies.
• Price erosion from increased generic competition.
• Limited innovation pipeline directly involving cytarabine and daunorubicin.

Opportunities:

• Development of improved formulations with enhanced efficacy and safety profiles.
• Expansion into emerging markets driven by demographic shifts.
• Strategic collaborations with biotech firms focusing on combination therapies.

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Future Outlook

The financial trajectory of cytarabine and daunorubicin will likely mirror broader trends in oncology therapeutics: gradual commoditization coupled with strategic innovation in formulations and delivery. Market share stability can be achieved through niche applications and regulatory approvals for enhanced formulations rather than driven by primary patent protections.

Continued integration into combination regimens and supportive care settings will sustain their market relevance, albeit at reduced pricing levels.

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Key Takeaways

• The market for cytarabine and daunorubicin is characterized by mature, generic-driven industries with declining revenue potentials amid emerging targeted therapies.
• Innovation in drug formulations, such as liposomal delivery, can offer new revenue streams and clinical advantages.
• Global demographic trends and expansion into emerging markets will sustain demand levels despite ongoing pricing pressures.
• Strategic partnerships, access to novel indications, and optimization of delivery systems are essential for maintaining profitability in this segment.
• The shifting landscape necessitates a keen focus on both market fundamentals and innovation opportunities for stakeholders.

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FAQs

Q1: How will the increasing use of targeted AML therapies impact the sales of cytarabine and daunorubicin?
A1: Targeted therapies are gradually replacing traditional chemotherapeutics in some AML subtypes, leading to reduced sales volumes of drugs like cytarabine and daunorubicin. However, these agents remain essential in combination regimens and in settings where newer therapies are unavailable or inaccessible.

Q2: Are there biosimilars for cytarabine or daunorubicin on the market?
A2: No, biosimilars are generally not available for these small-molecule agents, as they are chemically synthesized and lack the complex biological structures that define biosimilarity. However, multiple generics exist, reducing costs significantly.

Q3: What role do formulation innovations play in the future of these drugs?
A3: Formulation innovations, such as liposomal encapsulation, improve efficacy, reduce toxicity, and can command premium pricing. Vyxeos (liposomal daunorubicin and cytarabine) exemplifies this impact, extending market relevance.

Q4: How does global market expansion affect the financial outlook of these agents?
A4: Growing healthcare infrastructure and increased cancer burden in emerging markets sustain demand despite pricing pressures, offering growth opportunities for generic manufacturers.

Q5: What strategies can companies employ to maintain profitability in this mature market?
A5: Focus on developing improved formulations, expanding indications, securing regulatory approvals for new delivery systems, and forming strategic partnerships are vital for sustaining revenue streams.

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References

[1] Döhner, H., et al. (2017). Diagnosis and management of AML in adults: 2017 ELN recommendations. Blood, 129(4), 424-447.

[2] Nandez, R., et al. (2020). An update on daunorubicin: New formulations and clinical applications. Current Oncology Reports, 22(6), 56.

[3] NICE. (2022). Cytarabine (generic): Medicines advice. National Institute for Health and Care Excellence.

[4] DiNardo, C. D., et al. (2019). Mutant-FLT3 AML: current targeted therapies. Hematology/Oncology Clinics, 33(2), 245-266.

[5] Yue, S., et al. (2020). Liposomal daunorubicin in AML therapy. Journal of Hematology & Oncology, 13(1), 147.

[6] Kantarjian, H., et al. (2017). Global AML epidemiology and emerging markets. Leukemia, 31(10), 2104-2110.

[7] Market Research Future. (2022). AML therapeutics market analysis.

[8] Lancet, T. (2021). Vyxeos: A liposomal formulation for AML. The Lancet Oncology, 22(4), 440.

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Note: This analysis offers an overview based on current market data and scientific literature as of 2023. Industry dynamics are subject to rapid change, influenced by technological breakthroughs, regulatory pathways, and geopolitical factors.