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Last Updated: December 22, 2024

CYTOSAR-U Drug Patent Profile


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Which patents cover Cytosar-u, and what generic alternatives are available?

Cytosar-u is a drug marketed by Teva Pharms Usa and is included in one NDA.

The generic ingredient in CYTOSAR-U 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 Cytosar-u

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

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Summary for CYTOSAR-U
Drug patent expirations by year for CYTOSAR-U
Recent Clinical Trials for CYTOSAR-U

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

SponsorPhase
ImmunoGen, Inc.Phase 1
Fred Hutchinson Cancer CenterPhase 1
Therapeutic Advances in Childhood Leukemia ConsortiumPhase 1/Phase 2

See all CYTOSAR-U clinical trials

US Patents and Regulatory Information for CYTOSAR-U

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa CYTOSAR-U cytarabine INJECTABLE;INJECTION 075206-004 Dec 30, 1998 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa CYTOSAR-U cytarabine INJECTABLE;INJECTION 075206-002 Dec 30, 1998 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa CYTOSAR-U cytarabine INJECTABLE;INJECTION 075206-003 Dec 30, 1998 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa CYTOSAR-U cytarabine INJECTABLE;INJECTION 075206-001 Dec 30, 1998 DISCN 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

EU/EMA Drug Approvals for CYTOSAR-U

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Withdrawn no no no 2001-07-11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

CYTOSAR-U Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cytosar-U (Cytarabine)

Introduction to Cytosar-U (Cytarabine)

Cytosar-U, also known as cytarabine, is a chemotherapeutic agent widely used in the treatment of various types of leukemia, including acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL). Here, we will delve into the market dynamics and financial trajectory of cytarabine, highlighting key factors influencing its growth and projections.

Market Growth Drivers

Rising Prevalence of Leukemia

The global market for cytarabine is driven by the increasing prevalence of leukemia. As the global population ages, the incidence of cancers, including leukemia, is expected to rise. This trend is particularly evident in regions with aging populations, such as North America and Europe[1][4].

Advancements in Treatment Protocols

Advancements in chemotherapy regimens and the integration of cytarabine into combination therapies have enhanced its efficacy. For instance, high-dose cytarabine regimens have shown improved outcomes in AML patients, contributing to market growth[2][4].

Government and Private Funding

Significant funding from government, public, and private bodies towards cancer research and drug development is a crucial driver. This funding supports the development of more effective and targeted therapies, including those involving cytarabine[1][4].

Increasing Adoption of Chemotherapy

Chemotherapy remains a standard mode of treatment for various cancers, and cytarabine is a key component in many chemotherapy regimens. The widespread adoption of chemotherapy in both developed and developing countries fuels the demand for cytarabine[3][4].

Market Challenges

Regulatory Framework

The absence of a predefined regulatory framework can hinder the market growth of cytarabine. Stringent regulations regarding drug safety and efficacy can slow down the approval process and impact market dynamics[1].

Side Effects and Toxicity

Cytarabine is associated with several side effects, including myelosuppression, gastrointestinal toxicity, and pulmonary toxicity, especially at high doses. These adverse effects can limit its use and impact patient compliance[2].

Competition from Targeted Therapies

The oncology drugs market is witnessing a shift towards targeted therapies and immunotherapies, which have higher efficacy and fewer side effects. This trend could potentially reduce the market share of traditional cytotoxic drugs like cytarabine[3].

Financial Trajectory

Current Market Size

The global market for cytarabine is part of the broader oncology drugs market, which was valued at $231.56 billion in 2024. The AML therapeutics market, where cytarabine is a significant player, was estimated at $587.6 million in 2022[3][4].

Projected Growth

The AML therapeutics market, including cytarabine, is projected to reach $1.6 billion by 2030, growing at a CAGR of 13.4% from 2022 to 2030. Cytarabine itself is expected to record a 15.6% CAGR during this period, reaching $571.6 million by 2030[4].

Regional Performance

North America currently leads the market due to advanced healthcare infrastructure and high adoption rates of chemotherapy. However, the Asia Pacific region, particularly China and India, is expected to witness significant growth due to developing healthcare infrastructure and rising patient populations[1][4].

Key Players and Market Structure

Competitive Landscape

The market for cytarabine is moderately consolidated, with a few key players holding significant market shares. Companies like Celator Pharmaceuticals and Jazz Pharma are prominent in this market. Strategic partnerships and collaborations among these players are expected to drive market growth[1].

Market Segmentation

The oncology drugs market, including cytarabine, is segmented by drug type, cancer type, therapy, and route of administration. Cytarabine falls under the cytotoxic drugs segment, which is expected to remain dominant but will be challenged by the growing segment of targeted therapies[3].

Geographical Overview

North America

North America remains at the forefront of the cytarabine market due to the presence of several pharmaceutical and biosciences companies and a well-established healthcare system[1].

Asia Pacific

The Asia Pacific region is expected to exhibit the highest growth rate, driven by countries like China and India. Increasing disposable incomes and developing healthcare infrastructure in these regions are key factors[3][4].

Future Prospects

Innovative Applications

The market is expected to benefit from the presentation of innovative applications, including point-of-care testing and personalized medicine. Cost-effective lab tests and integrated analytical systems will also open new opportunities[1].

Emerging Therapies

The introduction of new therapies, such as FLT3 inhibitors, and the ongoing research in AML treatment are expected to drive the market forward. These emerging therapies may complement or potentially replace traditional chemotherapy regimens, including those involving cytarabine[4].

Key Takeaways

  • The global market for cytarabine is driven by rising leukemia prevalence, advancements in treatment protocols, and significant funding for cancer research.
  • The market faces challenges from stringent regulations and the emergence of targeted therapies.
  • The AML therapeutics market, including cytarabine, is projected to grow significantly, with cytarabine expected to reach $571.6 million by 2030.
  • North America leads the market, but the Asia Pacific region is expected to show the highest growth rate.
  • Innovative applications and emerging therapies will continue to shape the market dynamics.

FAQs

What is the current market size of the AML therapeutics market?

The global AML therapeutics market was estimated at $587.6 million in 2022[4].

What is the projected growth rate of the cytarabine market?

Cytarabine is expected to record a 15.6% CAGR from 2022 to 2030[4].

Which region is expected to show the highest growth rate for cytarabine?

The Asia Pacific region, particularly China and India, is expected to witness significant growth due to developing healthcare infrastructure and rising patient populations[3][4].

What are the main challenges facing the cytarabine market?

The main challenges include the absence of a predefined regulatory framework, side effects and toxicity associated with high-dose regimens, and competition from targeted therapies[1][2][3].

Who are the key players in the cytarabine market?

Key players include Celator Pharmaceuticals and Jazz Pharma, among others[1].

How is the market for cytarabine segmented?

The market is segmented by drug type, cancer type, therapy, and route of administration, with cytarabine falling under the cytotoxic drugs segment[3].

Sources

  1. Biospace: Cytarabine and Daunorubicin Market Key Players, Sales, Demand, Dynamic Forces, and Forecast 2029.
  2. Pfizer Labeling: CYTOSAR CYTARABINE Powder for solution for injection.
  3. Coherent Market Insights: Oncology Drugs Market to Reach USD 532.91 Billion by 2031.
  4. GlobeNewswire: Global Acute Myeloid Leukemia (AML) Therapeutics Strategic Research Report 2023.

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