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Last Updated: December 22, 2024

CERUBIDINE Drug Patent Profile


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Summary for CERUBIDINE
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Recent Clinical Trials for CERUBIDINE

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SponsorPhase
City of Hope Medical CenterPhase 1
Astellas Pharma IncPhase 2
PrECOG, LLC.Phase 2

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US Patents and Regulatory Information for CERUBIDINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma CERUBIDINE daunorubicin hydrochloride INJECTABLE;INJECTION 064103-001 Feb 3, 1995 AP RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sanofi Aventis Us CERUBIDINE daunorubicin hydrochloride INJECTABLE;INJECTION 061876-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wyeth Ayerst CERUBIDINE daunorubicin hydrochloride INJECTABLE;INJECTION 050484-001 Approved Prior to Jan 1, 1982 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

CERUBIDINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cerubidine (Daunorubicin)

Introduction

Cerubidine, known generically as daunorubicin, is an anthracycline aminoglycoside used primarily in the treatment of various forms of leukemia. This article delves into the market dynamics and financial trajectory of this critical anticancer drug.

Mechanism of Action and Uses

Daunorubicin works by intercalating between DNA base pairs, causing the uncoiling of the DNA helix and inhibiting DNA synthesis and RNA synthesis. This mechanism makes it effective in treating acute nonlymphocytic leukemia and acute lymphocytic leukemia in both children and adults[1][4].

Market Demand and Growth

The global market for cytarabine and daunorubicin, key drugs in leukemia treatment, is expected to grow at a healthy CAGR from 2020 to 2029. This growth is driven by several factors, including the rising percentage of geriatrics in the global population, the increasing prevalence of target diseases, and the growing demand for early detection and treatment of incurable diseases[3].

Key Market Drivers

  • Rising Geriatric Population: The increasing age of the global population contributes to a higher incidence of cancers, including leukemia, thereby driving the demand for daunorubicin.
  • Prevalence of Target Diseases: The growing number of leukemia cases worldwide enhances the market demand for effective treatments like daunorubicin.
  • Innovative Applications: Advances in medical technology and the development of new applications for daunorubicin, such as combination therapies, further boost market growth[3].

Market Challenges

Despite the growth drivers, the market faces several challenges:

  • Regulatory Framework: The absence of a predefined regulatory framework can hinder the demand for daunorubicin and other related drugs.
  • Safety and Efficacy Concerns: Daunorubicin is known for its cardiotoxicity, which requires careful cardiac monitoring and can limit its use in certain patients[4].

Financial Trajectory

Revenue and Market Share

The global cytarabine and daunorubicin market is highly competitive, with a few key players dominating the market. Companies like Celator Pharmaceuticals and Jazz Pharma are among the prominent players. The market is expected to benefit from significant funding from government, public, and private bodies aimed at developing effective treatments for chronic diseases[3].

Funding and Research

The financial trajectory of companies involved in the development and marketing of daunorubicin is often marked by significant research and development expenses. For example, CNS Pharmaceuticals, which is involved in clinical trials for related cancer treatments, reported a net loss of $5.6 million in Q3 2024, with R&D expenses increasing to $4.2 million. However, the company also secured additional funding to extend its operations and expand its pipeline[2].

Geographical Overview

The global market for cytarabine and daunorubicin is geographically diverse, with North America being a leading region due to the presence of several pharmaceutical and biosciences companies. Other regions, including Europe, Asia Pacific, Latin America, and the Middle East and Africa, also contribute significantly to the market[3].

Competitive Landscape

The market for daunorubicin is moderately consolidated, with a few leading vendors holding significant market share. These companies often engage in strategic partnerships to enhance their market position. The competitive landscape is also influenced by the advent of cost-effective lab tests and integrated analytical systems, which open new opportunities for market players[3].

Regulatory Considerations

Regulatory approvals and designations play a crucial role in the financial trajectory of drugs like daunorubicin. For instance, CNS Pharmaceuticals' lead program, Berubicin, received FDA Fast Track Designation and Orphan Drug Designation, which can significantly enhance market potential and attract additional funding[2].

Future Outlook

The future outlook for daunorubicin is promising, driven by ongoing research and the increasing demand for effective cancer treatments. However, the market will need to navigate challenges such as regulatory hurdles and safety concerns.

Key Statistics

  • Market Growth: The global cytarabine and daunorubicin market is expected to grow at a healthy CAGR from 2020 to 2029.
  • Revenue: The market is estimated to reach significant revenue by 2029, driven by growing demand and innovative applications.
  • R&D Expenses: Companies like CNS Pharmaceuticals are investing heavily in R&D, with expenses increasing by 23.5% in Q3 2024[2][3].

Conclusion

The market dynamics and financial trajectory for Cerubidine (daunorubicin) are influenced by a combination of factors including growing demand, regulatory considerations, and significant research and development investments. While the market faces challenges such as regulatory frameworks and safety concerns, the overall outlook remains positive due to the critical role daunorubicin plays in cancer treatment.

Key Takeaways

  • Growing Demand: Driven by the rising geriatric population and prevalence of target diseases.
  • Regulatory Considerations: FDA designations and regulatory frameworks significantly impact market potential.
  • Financial Investments: Significant R&D expenses and funding are crucial for market growth.
  • Competitive Landscape: Moderately consolidated with leading vendors engaging in strategic partnerships.
  • Future Outlook: Promising, with ongoing research and increasing demand for effective cancer treatments.

FAQs

What is daunorubicin used for?

Daunorubicin is used to induce remission in acute nonlymphocytic leukemia and acute lymphocytic leukemia in both children and adults[1].

What are the key drivers of the daunorubicin market?

The key drivers include the rising geriatric population, prevalence of target diseases, and growing demand for early detection and treatment of incurable diseases[3].

What are the major challenges facing the daunorubicin market?

Challenges include the absence of a predefined regulatory framework and safety concerns such as cardiotoxicity[3][4].

Which regions are leading in the daunorubicin market?

North America is a leading region due to the presence of several pharmaceutical and biosciences companies[3].

How do regulatory designations impact the market for daunorubicin?

Regulatory designations such as FDA Fast Track Designation and Orphan Drug Designation can significantly enhance market potential and attract additional funding[2].

Sources

  1. DrugBank: Daunorubicin: Uses, Interactions, Mechanism of Action.
  2. Stocktitan: CNS Pharmaceuticals Reports Third Quarter 2024 Financial Results.
  3. Biospace: Cytarabine and Daunorubicin Market Key Players, Sales, Demand.
  4. BC Cancer: DRUG NAME: Daunorubicin.

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