You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

CYTARABINE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Cytarabine is a drug marketed by Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Meitheal, Norvium Bioscience, Rising, Teva Parenteral, and West-ward Pharms Int. and is included in nineteen NDAs.

The generic ingredient in CYTARABINE is cytarabine. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the cytarabine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cytarabine

A generic version of CYTARABINE was approved as cytarabine by HIKMA on August 2nd, 1989.

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for CYTARABINE?
  • What are the global sales for CYTARABINE?
  • What is Average Wholesale Price for CYTARABINE?
Drug patent expirations by year for CYTARABINE
Drug Prices for CYTARABINE

See drug prices for CYTARABINE

Recent Clinical Trials for CYTARABINE

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

SponsorPhase
Syndax PharmaceuticalsPhase 1
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Phase 3
Fred Hutchinson Cancer CenterPhase 1

See all CYTARABINE clinical trials

Pharmacology for CYTARABINE
Medical Subject Heading (MeSH) Categories for CYTARABINE

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
Fresenius Kabi Usa CYTARABINE cytarabine INJECTABLE;INJECTION 076512-001 Jan 15, 2004 AP RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Parenteral CYTARABINE cytarabine INJECTABLE;INJECTION 016793-003 Dec 21, 1987 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira CYTARABINE cytarabine INJECTABLE;INJECTION 072168-001 Aug 31, 1990 AP RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma CYTARABINE cytarabine INJECTABLE;INJECTION 071471-001 Aug 2, 1989 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CYTARABINE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Parenteral CYTARABINE cytarabine INJECTABLE;INJECTION 016793-001 Approved Prior to Jan 1, 1982 3,444,294 ⤷  Subscribe
Teva Parenteral CYTARABINE cytarabine INJECTABLE;INJECTION 016793-002 Approved Prior to Jan 1, 1982 3,444,294 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.