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Last Updated: December 23, 2024

DAUNOXOME Drug Patent Profile


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

Daunoxome is a drug marketed by Galen (uk) and is included in one NDA.

The generic ingredient in DAUNOXOME is daunorubicin citrate. There are eleven drug master file entries for this compound. Additional details are available on the daunorubicin citrate profile page.

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Summary for DAUNOXOME
Drug patent expirations by year for DAUNOXOME
Recent Clinical Trials for DAUNOXOME

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SponsorPhase
University of Kansas Medical CenterPhase 1
Tara LinPhase 1
Vastra Gotaland RegionPhase 3

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US Patents and Regulatory Information for DAUNOXOME

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

DAUNOXOME Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DaunoXome

Introduction

DaunoXome, a liposomal formulation of daunorubicin citrate, is an antineoplastic agent used primarily in the treatment of AIDS-related Kaposi's sarcoma and other malignancies. To understand the market dynamics and financial trajectory of DaunoXome, it is crucial to delve into its clinical significance, market performance, and the broader pharmaceutical landscape.

Clinical Significance of DaunoXome

DaunoXome is distinguished by its liposomal delivery system, which enhances the bioavailability and reduces the toxicity of daunorubicin compared to its non-liposomal form. This formulation allows for higher peak plasma concentrations and a larger area under the plasma concentration-time curve (AUC), leading to improved efficacy and reduced side effects[1].

Mechanism of Action

Daunorubicin, the active ingredient in DaunoXome, works by intercalating between DNA base pairs and inhibiting topoisomerase II activity. This mechanism disrupts DNA replication and transcription, leading to cell death in rapidly dividing cancer cells[1].

Market Positioning

DaunoXome is a prescription drug, marketed by companies such as Galen (UK) and Eurohlth Intl. Its market positioning is strong within the niche of treating AIDS-related Kaposi's sarcoma, where it has shown significant clinical benefits.

Financial Performance

Sales and Revenue

The financial performance of DaunoXome can be inferred from the broader context of its parent company and similar products. For instance, Gilead Sciences, which is involved in the development and marketing of various antiviral and anticancer drugs, reported significant revenue growth in the early 2000s. Although specific financial data for DaunoXome is not readily available, the success of other liposomal formulations like AmBisome (amphotericin B) suggests that DaunoXome could have contributed substantially to the revenue streams of its manufacturers.

In the fourth quarter of 2003, Gilead Sciences reported net revenues from product sales totaling $255.6 million, with a significant portion coming from antiviral drugs. While DaunoXome is not explicitly mentioned, the growth in sales of other liposomal products indicates a favorable market environment for such formulations[3].

Market Growth and Trends

The market for liposomal drugs has been growing due to their improved pharmacokinetic profiles and reduced toxicity. DaunoXome, being a part of this category, benefits from this trend. The cost-effectiveness analysis of pegylated-liposomal doxorubicin, another liposomal anticancer drug, suggests that these formulations are becoming increasingly important in oncology treatment strategies[4].

Competitive Landscape

DaunoXome operates in a competitive landscape dominated by other anticancer agents. However, its unique liposomal formulation and targeted efficacy in treating AIDS-related Kaposi's sarcoma give it a distinct market position. The competition from non-liposomal daunorubicin formulations is mitigated by the superior pharmacokinetics and reduced side effects of DaunoXome[1].

Regulatory and Clinical Considerations

Regulatory Approval

DaunoXome has received regulatory approval for its use in treating specific types of cancer, particularly AIDS-related Kaposi's sarcoma. The approval process and subsequent market entry have been influenced by clinical trials demonstrating its efficacy and safety profile.

Clinical Trials and Efficacy

Clinical trials have shown that DaunoXome achieves higher peak plasma concentrations and AUCs compared to non-liposomal daunorubicin, leading to improved clinical outcomes. These trials have been crucial in establishing its market presence and justifying its use over conventional formulations[1].

Economic and Healthcare Impact

Cost-Effectiveness

The cost-effectiveness of DaunoXome is a critical factor in its market dynamics. While it may be more expensive than traditional daunorubicin, its improved efficacy and reduced toxicity can lead to better patient outcomes and lower long-term healthcare costs. Studies comparing the cost-effectiveness of liposomal formulations with conventional drugs highlight the potential economic benefits of using DaunoXome[4].

Healthcare Policy and Reimbursement

Healthcare policies and reimbursement strategies play a significant role in the market dynamics of DaunoXome. In regions where there is strong reimbursement support for innovative cancer therapies, the adoption and sales of DaunoXome are likely to be higher. The technology assessment by CMS and other healthcare organizations helps in evaluating the efficacy and cost-effectiveness of such treatments, influencing their inclusion in healthcare programs[5].

Future Outlook

Market Expansion

The future outlook for DaunoXome is tied to the expanding market for liposomal anticancer drugs. As research continues to highlight the benefits of these formulations, their adoption is expected to increase. Additionally, advancements in targeted therapies and personalized medicine could further enhance the market position of DaunoXome.

Research and Development

Ongoing research and development in the field of oncology are crucial for the continued relevance of DaunoXome. New clinical trials and studies aimed at expanding its indications or improving its delivery system could further bolster its market presence.

Key Takeaways

  • Improved Pharmacokinetics: DaunoXome's liposomal formulation enhances bioavailability and reduces toxicity compared to non-liposomal daunorubicin.
  • Clinical Efficacy: It has shown significant clinical benefits in treating AIDS-related Kaposi's sarcoma.
  • Market Positioning: Strong within the niche of treating specific malignancies, with a competitive edge due to its unique formulation.
  • Financial Performance: Contributes to the revenue streams of its manufacturers, although specific data is not readily available.
  • Regulatory and Clinical Considerations: Approved for specific indications, with ongoing clinical trials and evaluations influencing its market presence.
  • Economic and Healthcare Impact: Offers potential economic benefits due to improved efficacy and reduced long-term healthcare costs.

FAQs

What is DaunoXome used for?

DaunoXome is used primarily for the treatment of AIDS-related Kaposi's sarcoma and other specific malignancies.

How does DaunoXome differ from non-liposomal daunorubicin?

DaunoXome has a liposomal formulation that enhances bioavailability and reduces toxicity compared to non-liposomal daunorubicin.

What are the key benefits of DaunoXome?

The key benefits include higher peak plasma concentrations, a larger AUC, and reduced side effects, leading to improved clinical outcomes.

Is DaunoXome cost-effective?

Yes, despite being potentially more expensive than traditional daunorubicin, DaunoXome offers long-term economic benefits due to its improved efficacy and reduced toxicity.

What is the future outlook for DaunoXome?

The future outlook is positive, with expected market expansion driven by the growing demand for liposomal anticancer drugs and ongoing research aimed at improving its delivery system and expanding its indications.

Sources

  1. Pharmacompass: DaunoXome | Drug Information, Uses, Side Effects, Chemistry.
  2. MD Anderson Cancer Center: Hagop M. Kantarjian, MD.
  3. Gilead Sciences: Gilead Sciences Announces Fourth Quarter and Full Year 2003 Financial Results.
  4. Taylor & Francis Online: Cost-effectiveness Analysis of Pegylated-liposomal Doxorubicin and ...
  5. CMS: Technology Assessment - CMS.

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