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 Pharma Ltd, Hikma, Hospira, Meitheal, Norvium Bioscience, Rising, Teva Parenteral, West-ward Pharms Int, Teva Pharms Usa, and Celator Pharms, 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:	123
Clinical Trials:	1,314
Patent Applications:	7,491
Drug Prices:	Drug price trends for cytarabine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
Syndax Pharmaceuticals	Phase 1
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.	Phase 3
Fred Hutchinson Cancer Center	Phase 1

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
Norvium Bioscience	CYTARABINE	cytarabine	INJECTABLE;INJECTION	200916-001	Dec 13, 2011		DISCN	No	No
Meitheal	CYTARABINE	cytarabine	INJECTABLE;INJECTION	205696-001	Jul 17, 2018	AP	RX	No	No
Gland Pharma Ltd	CYTARABINE	cytarabine	INJECTABLE;INJECTION	211937-001	Dec 23, 2019	AP	RX	No	No
Teva Parenteral	CYTARABINE	cytarabine	INJECTABLE;INJECTION	016793-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Meitheal	CYTARABINE	cytarabine	INJECTABLE;INJECTION	208485-001	Feb 28, 2022	AP	RX	No	No
Teva Pharms Usa	CYTOSAR-U	cytarabine	INJECTABLE;INJECTION	075206-003	Dec 30, 1998		DISCN	No	No

Expired US Patents for cytarabine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999	7,198,801
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999	5,455,044
Teva Parenteral	CYTARABINE	cytarabine	INJECTABLE;INJECTION	016793-002	Approved Prior to Jan 1, 1982	3,444,294
Teva Parenteral	CYTARABINE	cytarabine	INJECTABLE;INJECTION	016793-001	Approved Prior to Jan 1, 1982	3,444,294
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999	6,071,534
Pacira Pharms Inc	DEPOCYT	cytarabine	INJECTABLE, LIPOSOMAL;INJECTION	021041-001	Apr 1, 1999	5,962,016

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/000317 Intrathecal 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

Cytarabine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cytarabine

Introduction to Cytarabine

Cytarabine, a chemotherapeutic agent, is widely used in the treatment of various hematologic malignancies, particularly acute myeloid leukemia (AML) and other blood cancers. Here, we delve into the market dynamics and financial trajectory of cytarabine, highlighting key drivers, challenges, and future projections.

Market Size and Growth

The global cytarabine market has been experiencing significant growth. As of 2023, the cytarabine and daunorubicin market, which often includes cytarabine, was valued at USD 128 million and is projected to reach USD 184 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.3% from 2024 to 2031[1].

Key Drivers of Market Growth

Several factors are driving the growth of the cytarabine market:

Increased Prevalence of Blood Malignancies

The rising incidence of acute myeloid leukemia (AML) and other blood cancers is a primary driver. As the global population ages, the prevalence of these diseases is expected to increase, thereby boosting the demand for effective treatments like cytarabine[1][4].

Advances in Clinical Research and Treatment Regimens

Continuous research and development aimed at improving the efficacy and reducing the side effects of cytarabine are enhancing its market appeal. Combination therapies, such as those involving venetoclax, have shown promising results, further driving the adoption of cytarabine[5].

Growing Emphasis on Personalized Medicine

The increasing focus on personalized and targeted therapies is another significant driver. Cytarabine, when used in combination with other drugs, can offer more tailored treatment options, which is a growing trend in oncology[1][4].

Market Segmentation

The cytarabine market is segmented based on several criteria:

Application

• Cytarabine injection
• Cytarabine tablets
• Combination therapies
• Leukemia treatment
• Lymphoma treatment
• Cancer therapy
• Chemotherapy regimens
• Blood cancer treatment[1].

Product Type

The market is also segmented by product type, including different formulations and uses of cytarabine.

Geographical Regions

The market is analyzed across various geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. North America is a leading region due to the presence of several pharmaceutical and biosciences companies[1][4].

Financial Implications and Challenges

While the market for cytarabine is growing, there are significant financial challenges associated with its use:

High Treatment Costs

Cytarabine, especially when used in combination therapies or as part of long-term treatment regimens, can be costly. The financial burden on patients, particularly those in countries with market-driven pricing mechanisms like the United States, can be substantial. High costs often lead to financial toxicity, characterized by medical debt, income loss, and psychological stress[2].

Patient Access and Adherence

The high costs of cytarabine and other cancer therapies can impact patient adherence and quality of life. Many patients face substantial out-of-pocket expenses, which can lead to treatment abandonment or inability to access these drugs altogether[2].

Competitive Landscape

The cytarabine market is moderately consolidated with a few key players dominating the landscape. Companies such as Teva, Fresenius Kabi, and others are focusing on strengthening their product portfolios and expanding their business globally. Strategic partnerships and investments in research and development are common strategies among these players[3][4].

Future Prospects and Opportunities

Despite the challenges, the cytarabine market is poised for continued growth:

Increasing Funding for Pharmaceutical Research

Government, public, and private funding for pharmaceutical research is on the rise, which is expected to support the development of more effective and cost-efficient treatments involving cytarabine[4].

Advances in Diagnostic and Treatment Technologies

The integration of point-of-care testing, personalized medicine, and cost-effective lab tests is expected to open new opportunities for the cytarabine market. These advancements will make treatments more accessible and efficient[4].

Growing Demand in Emerging Markets

The construction of healthcare infrastructure in emerging markets is likely to drive the growth of the cytarabine market in these regions. As healthcare access improves, the demand for effective cancer treatments will increase[1][4].

Key Takeaways

• The cytarabine market is growing due to the increasing prevalence of blood malignancies and advances in treatment regimens.
• High treatment costs and financial toxicity remain significant challenges.
• The market is segmented by application, product type, and geographical region.
• Key players are focusing on strategic partnerships and research and development to strengthen their market position.
• Future growth is expected to be driven by increased funding for pharmaceutical research and advances in diagnostic and treatment technologies.

FAQs

What is the projected market size of cytarabine by 2031?

The cytarabine and daunorubicin market is expected to reach USD 184 million by 2031, growing at a CAGR of 5.3% from 2024 to 2031[1].

What are the main drivers of the cytarabine market growth?

The main drivers include the increasing prevalence of blood malignancies, advances in clinical research and treatment regimens, and the growing emphasis on personalized medicine[1][4].

How does the cost of cytarabine impact patient care?

The high cost of cytarabine can lead to financial toxicity, affecting patient adherence and quality of life. Many patients face substantial out-of-pocket expenses, which can result in treatment abandonment or inability to access the drug[2].

Which regions are leading in the cytarabine market?

North America is currently at the forefront in terms of growth opportunities and developments in the cytarabine market, due to the presence of several pharmaceutical and biosciences companies[1][4].

What are the key strategies adopted by major players in the cytarabine market?

Major players are focusing on strategic partnerships, research and development, and expanding their product portfolios to strengthen their market position[3][4].

Sources

1. Market Research Intellect: Cytarabine And Daunorubicin Market Size and Projections.
2. Oxford University Press: Financial challenges of being on long-term, high-cost medications.
3. Cognitive Market Research: Cytarabine Market Report 2024 (Global Edition).
4. BioSpace: Cytarabine and Daunorubicin Market Key Players, Sales, Demand, Dynamic Forces, and Forecast 2029.
5. ASH Publications: Clinical and molecular predictors of response and survival following venetoclax combination therapy in patients with relapsed or refractory acute myeloid leukemia.