Cytarabine - Generic Drug Details

What are the generic drug sources for cytarabine and what is the scope of patent protection?

Cytarabine is the generic ingredient in four branded drugs marketed by Pacira Pharms Inc, Fresenius Kabi Usa, Gland, Hikma, Hospira, Meitheal, Pharmobedient, Rising, Teva Parenteral, West-ward Pharms Int, Teva Pharms Usa, and Jazz Pharms Therap, and is included in twenty-two NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for cytarabine. Five suppliers are listed for this compound.

Summary for cytarabine

US Patents:	9
Tradenames:	4
Applicants:	12
NDAs:	22
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1,423
Patent Applications:	8,231
Drug Prices:	Drug price trends for cytarabine
What excipients (inactive ingredients) are in cytarabine?	cytarabine excipients list
DailyMed Link:	cytarabine at DailyMed

See drug prices for cytarabine

Recent Clinical Trials for cytarabine

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

Sponsor	Phase
Dana-Farber Cancer Institute	PHASE2
Children's Oncology Group	PHASE2
Children's Oncology Group	PHASE3

See all cytarabine clinical trials

Pharmacology for cytarabine

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

Medical Subject Heading (MeSH) Categories for cytarabine

Antimetabolites, Antineoplastic

Antiviral Agents

Immunosuppressive Agents

Anatomical Therapeutic Chemical (ATC) Classes for cytarabine

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

US Patents and Regulatory Information for cytarabine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Meitheal	CYTARABINE	cytarabine	INJECTABLE;INJECTION	206190-001	Nov 9, 2017		DISCN	No	No
Rising	CYTARABINE	cytarabine	INJECTABLE;INJECTION	200915-001	Dec 13, 2011	AP	RX	No	No
Rising	CYTARABINE	cytarabine	INJECTABLE;INJECTION	201784-001	Jan 30, 2012	AP	RX	No	No
Jazz Pharms Therap	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes			Y
Meitheal	CYTARABINE	cytarabine	INJECTABLE;INJECTION	208485-001	Feb 28, 2022	AP	RX	No	No

Expired US Patents for cytarabine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Parenteral	CYTARABINE	cytarabine	INJECTABLE;INJECTION	016793-002	Approved Prior to Jan 1, 1982
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999
Teva Parenteral	CYTARABINE	cytarabine	INJECTABLE;INJECTION	016793-001	Approved Prior to Jan 1, 1982
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999

EU/EMA Drug Approvals for cytarabine

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pacira Limited	DepoCyte	cytarabine	EMEA/H/C/000317Intrathecal treatment of lymphomatous meningitis. In the majority of patients such treatment will be part of symptomatic palliation of the disease.	Withdrawn	no	no	no	2001-07-11

Market Dynamics and Financial Trajectory for Cytarabine

Last updated: July 27, 2025

Introduction

Cytarabine, also known as cytosine arabinoside or Ara-C, is a chemotherapeutic agent primarily used in the treatment of hematological malignancies such as acute myeloid leukemia (AML), non-Hodgkin lymphoma, and certain myelodysplastic syndromes. First approved in the 1960s, cytarabine remains a cornerstone in oncology, driven by ongoing clinical applications, evolving treatment protocols, and licensing agreements. This report analyzes current market dynamics, pricing trends, competitive landscape, and future financial trajectories for cytarabine, offering insights into strategic market positioning for stakeholders.

Market Overview

The global cytarabine market is characterized by its niche application scope, largely confined to hematologic cancers, and its strong foothold in chemotherapy regimens. The compound's pharmacological profile is well-established, which has resulted in consistent demand, particularly in regions with advanced healthcare infrastructure. Despite its longstanding presence, the market faces challenges stemming from patent expirations, the emergence of targeted therapies, and biosimilars.

Key Market Segments

• Therapeutic Indications: AML (approximately 60% of use), non-Hodgkin lymphoma, myelodysplastic syndromes, and certain solid tumors.
• Geographic Distribution: North America dominates due to high healthcare expenditure and AML prevalence. Europe follows, with Asia-Pacific showing increased growth potential due to expanding healthcare access and rising cancer prevalence.
• Formulations: Injectable formulations dominate, with oral variants gaining traction due to quality-of-life improvements in outpatient settings.

Market Drivers

• Prevalence of Hematological Cancers: Rising AML incidences, especially in aging populations, sustain steady demand.
• Advances in Combination Therapies: Cytarabine remains integral to combination chemotherapies, extending its market relevance.
• Healthcare Infrastructure Expansion: Improved diagnostic and treatment capabilities in emerging markets foster growth.

Market Restraints

• Patent Expirations and Generics: Several formulations have lost patent exclusivity, increasing generic competition and suppressing prices.
• Emerging Treatment Alternatives: Novel targeted agents and immunotherapies threaten to displace traditional chemotherapies.
• Toxicity Profile: Adverse effects curtail aggressive use in certain patient populations, impacting volume.

Market Dynamics

Competitive Landscape

The cytarabine market comprises a mix of generic manufacturers, biotech firms, and multinational pharmaceutical companies. Major players include Teva Pharmaceuticals, Hospira (Pfizer), and Sandoz, which dominate the production of generic versions. Meanwhile, pharmaceutical giants, such as Bristol-Myers Squibb and Novartis, are investing in clinical studies for new combinations and derivatives.

The entry of biosimilars and generics post-patent expiry has compressed profit margins, compelling companies to innovate. Although no new patent-protected formulations of cytarabine are in late-stage development, combinatorial approaches incorporating cytarabine with targeted agents are under investigation, which may influence future market dynamics.

Pricing Trends

Pricing for cytarabine remains relatively stable in established markets, with a shift toward commoditization with the proliferation of generics. Wholesale acquisition costs (WAC) for the injectable form vary across regions, typically ranging from $50 to $200 per dose. In the United States, increased competition has driven down prices, but reimbursement policies and insurance coverage significantly influence actual costs passed to patients and providers.

Regulatory Considerations

Regulatory pathways favor biosimilar approvals and generic substitutions, especially in regions like the US, EU, and Japan. Fast-track approvals for combination regimens incorporating cytarabine are also influencing market access strategies.

Emerging Trends

• Personalized Oncology: Integration of cytarabine within precision medicine frameworks, especially via biomarker-driven approaches, can potentially redefine its usage.
• Novel Formulations: Liposomal and depot formulations are under exploration to enhance pharmacokinetics and reduce toxicity.
• International Expansion: Growth in low- and middle-income countries (LMICs) is feasible through cost-effective generics and improved healthcare infrastructure.

Financial Trajectory and Future Outlook

The long-term financial outlook for cytarabine is marked by subtle growth trajectories, influenced predominantly by generic erosion and alternative therapy development. However, certain niches present growth opportunities:

Revenue Forecasts

• Current Market Values: The global cytarabine market is estimated at USD 200–300 million annually, predominantly driven by North American sales.
• Growth Rate Projections: Compound Annual Growth Rate (CAGR) is projected at approximately 2–3% over the next five years, stabilizing as patent expiries and biosimilar entries saturate markets.

Impact of Combining Therapies

The emergence of targeted therapies, such as FLT3 inhibitors (e.g., midostaurin) and IDH inhibitors, could limit monotherapy sales but simultaneously open avenues for combination regimens. This shift may result in incremental revenues through co-formulations and extended indications.

Market Expansion in Emerging Economies

Expansion into LMICs via affordable generics and local manufacturing could deliver durable revenue streams, albeit at lower margins. Strategic partnerships with regional healthcare providers stand to benefit manufacturers.

Research & Development Outlook

Limited R&D efforts are directed at enhancing cytarabine's pharmacological profile, with most innovation centered on combination therapies and delivery mechanisms rather than the molecule itself. Investment in such innovations can provide competitive edge and potential for premium pricing in niche markets.

Regulatory and Patent Landscape

Patents protecting specific formulations or delivery systems are expiring or have already expired, permitting generic manufacturing. Nonetheless, proprietary combination kits or adjunct formulations could sustain exclusivity and revenue in certain segments.

Market Challenges and Opportunities

While the core cytarabine market faces mature dynamics, opportunities arise in niche applications, combination therapies, and biosimilar proliferation. Regulatory pathways facilitate rapid market entry of generics, exerting downward pressure on prices but also consolidating market share for established manufacturers.

The increasing use of minimal residual disease (MRD) monitoring may refine treatment protocols, optimizing dose and duration of cytarabine therapy, influencing demand patterns.

Conclusion

Cytarabine's market trajectory reflects a mature landscape characterized by steady volume but declining unit prices due to generic competition. Nonetheless, its critical role in hematologic cancer management sustains demand, with incremental growth fostered through novel combination regimens, biosimilar entries, and expanding global access. Strategic positioning in emerging markets and innovation in delivery formats could offset declines stemming from patent expirations.

Stakeholders poised to succeed will align with evolving clinical guidelines, capitalize on biosimilar opportunities, and invest in combination approaches that redefine cytarabine's therapeutic utility.

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Key Takeaways

• The global cytarabine market is mature with slight CAGR growth (~2–3%) projected over the next five years.
• Patent expiries and biosimilar proliferation pressure prices downward but broaden access.
• Demand persists primarily in AML and other hematologic malignancies, with potential expansion via combination therapies.
• Market expansion in emerging markets offers growth opportunities, especially through cost-effective generics.
• Innovation in formulations and integration into personalized medicine may create niche revenue streams.

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FAQs

1. What is the primary clinical use of cytarabine?
Cytarabine is primarily used to treat acute myeloid leukemia (AML), as well as other hematological malignancies, including non-Hodgkin lymphoma and myelodysplastic syndromes.

2. How have patent expirations affected the cytarabine market?
Patent expirations led to an influx of generic manufacturers, decreasing prices and consolidating market share among low-cost producers, while also intensifying competition.

3. Are there new formulations of cytarabine in development?
Research is ongoing into liposomal and depot formulations to improve pharmacokinetics and reduce toxicity; however, no major new formulations have achieved widespread clinical adoption yet.

4. How do biosimilars influence the future of cytarabine?
While biosimilar development is more common for biologics, generic versions of cytarabine’s injectable forms dominate the market, exerting downward pressure on prices and influencing competitive strategies.

5. What potential growth areas could impact cytarabine's market?
Integration into combination therapies, expanding use in emerging markets with affordable generics, and development of new formulations could create future growth opportunities.

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Sources:

1. [1] Market Research Future. “Cytarabine (Ara-C) Market Size, Share, Trends, Growth and Forecast to 2030.”
2. [2] Global Data. “Hematologic Oncology Pipeline Analysis.”
3. [3] U.S. Food and Drug Administration (FDA). Drug approvals and patent data.