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Last Updated: December 23, 2024

Daunorubicin citrate - Generic Drug Details


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What are the generic sources for daunorubicin citrate and what is the scope of patent protection?

Daunorubicin citrate is the generic ingredient in one branded drug marketed by Galen (uk) and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for daunorubicin citrate.

Summary for daunorubicin citrate
Recent Clinical Trials for daunorubicin citrate

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

SponsorPhase
Haining Health-Coming Biotech Co., Ltd.Phase 2
Alphacait, LLCPhase 2
AIDS Malignancy ConsortiumPhase 1

See all daunorubicin citrate clinical trials

US Patents and Regulatory Information for daunorubicin citrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galen (uk) DAUNOXOME daunorubicin citrate INJECTABLE, LIPOSOMAL;INJECTION 050704-002 Apr 8, 1996 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

Daunorubicin citrate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Daunorubicin Citrate

Introduction to Daunorubicin Citrate

Daunorubicin citrate, often used in conjunction with cytarabine, is a crucial chemotherapeutic agent 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 this essential drug.

Market Size and Growth Projections

The market for daunorubicin citrate, as part of the broader cytarabine and daunorubicin market, is experiencing significant growth. As of 2023, the market size 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 daunorubicin citrate market:

Increased Prevalence of Blood Malignancies

The rising incidence of acute myeloid leukemia (AML) and other blood malignancies is a primary driver. As the global population ages, the demand for effective treatments for these diseases increases[1][3].

Advances in Clinical Research

Continuous research and development aimed at improving the efficacy and reducing the side effects of daunorubicin citrate are enhancing its market appeal. The development of combination therapies, such as liposomal daunorubicin and cytarabine, has shown promising results in clinical trials[2].

Growing Emphasis on Personalized Medicine

The increasing focus on personalized and targeted therapies is driving innovations in drug formulations and delivery modalities, further boosting the market for daunorubicin citrate[1][3].

Investment in Oncology Research

Significant investments in oncology research and the expansion of healthcare infrastructure in emerging markets are also contributing to the market's growth[1].

Cost-Effectiveness and Economic Impact

The cost-effectiveness of daunorubicin citrate, particularly in its liposomal form, is a critical aspect of its market dynamics.

Cost Comparison

Liposomal daunorubicin and cytarabine (Vyxeos) has been shown to offer better overall survival rates compared to conventional cytarabine and daunorubicin (7 + 3) regimens. However, it is not considered cost-effective at current prices, with an estimated incremental cost-effectiveness ratio (ICER) of $110,283 per quality-adjusted life-year (QALY) compared to the 7 + 3 regimen. A price reduction of at least 68% would be necessary for it to be considered cost-effective at a $50,000 per QALY threshold[2].

Budget Impact

The introduction of liposomal daunorubicin and cytarabine is expected to have a significant budget impact, with estimated costs ranging from $4.4 million in the first year to $34.3 million over three years for inpatient settings[2].

Market Segmentation

The market for daunorubicin citrate is segmented based on several factors:

Application

  • Cytarabine injection
  • Daunorubicin injection
  • Cytarabine tablets
  • Daunorubicin tablets
  • Combination therapies[1]

Product

  • Leukemia treatment
  • Lymphoma treatment
  • Cancer therapy
  • Chemotherapy regimens
  • Blood cancer treatment[1]

Geography

  • North America
  • Europe
  • Asia-Pacific
  • South America
  • Middle-East and Africa[1]

Key Players and Competitive Landscape

The market is moderately consolidated with several key players:

Major Companies

  • Pfizer
  • Teva
  • Mylan
  • Cipla
  • Fresenius Kabi
  • Sandoz
  • Sun Pharma
  • Dr. Reddy's Laboratories
  • Novartis
  • Hospira[1]
  • Celator Pharmaceuticals
  • Jazz Pharma[3]

These companies are engaged in strategic partnerships, product benchmarking, and continuous research to maintain their market position.

Regulatory and Economic Challenges

Despite the growth prospects, the market faces several challenges:

Regulatory Framework

The absence of a predefined regulatory framework can hinder the demand for daunorubicin citrate. Stringent regulations about drug development processes and quality control can also impact market dynamics[3].

Cost and Accessibility

The high cost of liposomal daunorubicin and cytarabine, as discussed earlier, is a significant barrier to its widespread adoption. The need for substantial price reductions to achieve cost-effectiveness is a major challenge[2].

Future Outlook

The future of daunorubicin citrate looks promising, driven by several factors:

Growing Demand for Early Detection

The increasing demand for early detection and treatment of incurable diseases, along with the rising geriatric population, will continue to drive the market[3].

Innovative Applications

The presentation of innovative applications, such as point-of-care testing and personalized medicine, will open new opportunities for the market[3].

Funding and Research

Continued funding from government, public, and private bodies towards oncology research will support the development of more effective and cost-efficient treatments[3].

Key Takeaways

  • The daunorubicin citrate market is projected to grow at a CAGR of 5.3% from 2024 to 2031.
  • The market is driven by the increasing prevalence of blood malignancies, advances in clinical research, and growing emphasis on personalized medicine.
  • Cost-effectiveness remains a challenge, with liposomal formulations requiring significant price reductions to be viable.
  • Key players are focusing on strategic partnerships and continuous research to maintain market share.
  • Regulatory and economic challenges need to be addressed to fully realize the market's potential.

FAQs

Q: What is the current market size of the cytarabine and daunorubicin market? A: The market size was valued at USD 128 million in 2023[1].

Q: What is the projected growth rate of the daunorubicin citrate market? A: The market is expected to grow at a CAGR of 5.3% from 2024 to 2031[1].

Q: What are the key drivers of the daunorubicin citrate market? A: Key drivers include the increased prevalence of blood malignancies, advances in clinical research, and the growing emphasis on personalized medicine[1][3].

Q: Is liposomal daunorubicin and cytarabine cost-effective? A: Currently, it is not considered cost-effective at a $50,000 per QALY threshold and requires a significant price reduction to be viable[2].

Q: Who are the major players in the daunorubicin citrate market? A: Major players include Pfizer, Teva, Mylan, Cipla, Fresenius Kabi, and others[1][3].

Sources

  1. Market Research Intellect: Cytarabine And Daunorubicin Market Size and Projections.
  2. Canada's Drug Agency: Daunorubicin and Cytarabine (Vyxeos) - CADTH Final Report.
  3. Biospace: Cytarabine and Daunorubicin Market Key Players, Sales, Demand, Dynamic Forces, and Forecast 2029.

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