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Last Updated: December 22, 2024

DAUNORUBICIN HYDROCHLORIDE Drug Patent Profile


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Which patents cover Daunorubicin Hydrochloride, and what generic alternatives are available?

Daunorubicin Hydrochloride is a drug marketed by Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Meitheal, and Teva Parenteral. and is included in seven NDAs.

The generic ingredient in DAUNORUBICIN HYDROCHLORIDE is daunorubicin hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the daunorubicin hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Daunorubicin Hydrochloride

A generic version of DAUNORUBICIN HYDROCHLORIDE was approved as daunorubicin hydrochloride by HIKMA on January 30th, 1998.

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Summary for DAUNORUBICIN HYDROCHLORIDE
US Patents:0
Applicants:5
NDAs:7
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 68
Clinical Trials: 374
Patent Applications: 4,682
What excipients (inactive ingredients) are in DAUNORUBICIN HYDROCHLORIDE?DAUNORUBICIN HYDROCHLORIDE excipients list
DailyMed Link:DAUNORUBICIN HYDROCHLORIDE at DailyMed
Drug patent expirations by year for DAUNORUBICIN HYDROCHLORIDE
Recent Clinical Trials for DAUNORUBICIN HYDROCHLORIDE

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

SponsorPhase
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Phase 3
Uwe PlatzbeckerPhase 2
Gilead SciencesPhase 2

See all DAUNORUBICIN HYDROCHLORIDE clinical trials

Pharmacology for DAUNORUBICIN HYDROCHLORIDE

US Patents and Regulatory Information for DAUNORUBICIN HYDROCHLORIDE

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 DAUNORUBICIN HYDROCHLORIDE daunorubicin hydrochloride INJECTABLE;INJECTION 065034-001 Nov 20, 2001 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Parenteral DAUNORUBICIN HYDROCHLORIDE daunorubicin hydrochloride INJECTABLE;INJECTION 064212-001 Jun 23, 1998 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hisun Pharm Hangzhou DAUNORUBICIN HYDROCHLORIDE daunorubicin hydrochloride INJECTABLE;INJECTION 208759-001 Apr 12, 2019 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Parenteral DAUNORUBICIN HYDROCHLORIDE daunorubicin hydrochloride INJECTABLE;INJECTION 064212-002 May 3, 1999 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fresenius Kabi Usa DAUNORUBICIN HYDROCHLORIDE daunorubicin hydrochloride INJECTABLE;INJECTION 065000-001 May 25, 1999 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

DAUNORUBICIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Daunorubicin Hydrochloride

Market Overview

Daunorubicin Hydrochloride, an anthracycline antibiotic, is a critical chemotherapy drug used primarily in the treatment of various cancers, including leukemia and solid tumors. The market for this drug is driven by several key factors that are shaping its growth and financial trajectory.

Increasing Prevalence of Cancer

The global burden of cancer, particularly leukemia, is a major driver of the Daunorubicin Hydrochloride market. With cancer rates increasing worldwide, there is a corresponding rise in the demand for effective chemotherapy drugs like Daunorubicin Hydrochloride. This trend is especially pronounced in developing regions where healthcare infrastructure is improving, leading to earlier diagnosis and treatment[1][4].

Advances in Drug Delivery and Formulations

Advances in drug delivery systems, such as targeted therapies and nanoparticle-based delivery, are enhancing the effectiveness of Daunorubicin Hydrochloride. These advancements are not only improving treatment outcomes but also reducing systemic toxicity, making the drug more appealing to both healthcare providers and patients[1][4].

Research and Development

Continuous research and development efforts are aimed at improving the efficacy of Daunorubicin Hydrochloride and lowering its side effects. This includes exploring new formulations and combinations with other chemotherapy agents. The integration of artificial intelligence and genomic profiling in treatment decision-making is expected to further revolutionize cancer care, potentially increasing the efficacy of Daunorubicin Hydrochloride[3][4].

Regulatory Approvals and Quality Control

Regulatory approvals and stringent quality control measures significantly influence market dynamics. Ensuring compliance with regulatory standards is crucial for pharmaceutical companies to maintain market share and expand their product reach. This also impacts pricing strategies, especially between branded and generic formulations[4].

Market Segmentation

The Daunorubicin Hydrochloride market is segmented by type (branded and generics) and application (hospitals, clinics, ambulatory surgical centers). Geographically, the market is divided into North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. Each segment presents unique opportunities and challenges:

  • Branded vs. Generic: Generic Daunorubicin Hydrochloride often captures a larger market share due to its cost-effectiveness, while branded formulations focus on product differentiation and regulatory compliance[2][4].
  • Hematological Cancers: This segment is highly competitive, with key players focusing on product differentiation and strategic partnerships to gain market share[4].
  • Geographical Regions: Asia-Pacific is a rapidly growing region, driven by countries like China, Japan, India, and South Korea, due to a large population, rising disposable income, and increasing urbanization[1].

Financial Trajectory

Market Size and Growth Rate

The global Daunorubicin Hydrochloride market is anticipated to grow at a compound annual growth rate (CAGR) of 12.08% between 2024 and 2031. The market is expected to transition from a valuation of USD 17.83 Billion in 2024 to USD 39.61 Billion by 2031[1].

Revenue Projections

The market size and revenue projections indicate a sustained and significant expansion from 2024 to 2031. For instance, the Cytarabine and Daunorubicin market, closely related to Daunorubicin Hydrochloride, was valued at USD 128 Million in 2023 and is expected to reach USD 184 Million by 2031, growing at a 5.3% CAGR[3].

Key Players and Market Competition

The market is characterized by the presence of both generic and branded formulations, with key players such as Pfizer, Cipla, TEVA, and Hisun Pharma. These companies are investing significantly in research and development to enhance drug efficacy, reduce side effects, and explore new therapeutic indications. Strategic alliances with healthcare providers and academic institutions are also crucial for expanding market reach and ensuring product accessibility[1][2][4].

Mergers and Acquisitions

The Daunorubicin Hydrochloride market is witnessing a wave of mergers and acquisitions as companies seek to consolidate their market positions, expand their product portfolios, and leverage synergies to drive growth and competitiveness. These strategic consolidations provide access to new technologies, intellectual property, and talent, enabling companies to innovate faster and stay ahead of market trends[1].

Emerging Markets and Urbanization

Emerging economies, particularly in the Asia-Pacific region, are witnessing rising adoption of chemotherapy treatments due to increasing urbanization, rising disposable income, and improvements in healthcare infrastructure. This trend is contributing significantly to the market expansion of Daunorubicin Hydrochloride[1][4].

Challenges and Opportunities

Despite the positive growth trajectory, the market faces challenges such as drug resistance, regulatory complexities, and healthcare disparities across regions. However, these challenges also present opportunities for innovation, particularly in the development of targeted therapies and personalized medicine approaches. Expanding indications beyond traditional uses, such as in pediatric oncology or rare cancers, also presents avenues for market growth and differentiation[4].

"Advances in clinical research and the development of combination medicines are increasing the efficacy of these drugs, accelerating their uptake. Furthermore, the increased emphasis on customized medicine and targeted therapy is driving advances in medication formulations and delivery modalities."[3]

Key Takeaways

  • Growing Cancer Burden: The increasing global cancer burden, particularly in leukemia, is a major driver of the Daunorubicin Hydrochloride market.
  • Advances in Drug Delivery: Improvements in drug delivery systems and formulations are enhancing treatment outcomes and reducing side effects.
  • Research and Development: Continuous R&D efforts are aimed at improving efficacy and exploring new therapeutic indications.
  • Regulatory Compliance: Ensuring regulatory compliance is crucial for maintaining market share and expanding product reach.
  • Market Segmentation: The market is segmented by type, application, and geographical regions, each presenting unique opportunities and challenges.
  • Financial Growth: The market is expected to grow at a CAGR of 12.08% from 2024 to 2031, reaching a valuation of USD 39.61 Billion by 2031.

FAQs

  1. What is the expected CAGR of the Daunorubicin Hydrochloride market from 2024 to 2031?

    • The Daunorubicin Hydrochloride market is anticipated to grow at a CAGR of 12.08% from 2024 to 2031[1].
  2. What are the primary drivers of the Daunorubicin Hydrochloride market?

    • The primary drivers include the growing global burden of cancer, advances in drug delivery systems, and ongoing research aimed at expanding therapeutic applications[1][4].
  3. Who are the key players in the Daunorubicin Hydrochloride market?

    • Key players include Pfizer, Cipla, TEVA, Hisun Pharma, and others[1][2].
  4. What are the challenges faced by the Daunorubicin Hydrochloride market?

    • Challenges include drug resistance, regulatory complexities, and healthcare disparities across regions[4].
  5. How is the market segmented, and what are the implications of each segment?

    • The market is segmented by type (branded and generics), application (hospitals, clinics, ambulatory surgical centers), and geographical regions. Each segment presents unique opportunities and challenges, with generic formulations often being more cost-effective and branded formulations focusing on product differentiation[2][4].

Sources

  1. OpenPR: Daunorubicin Hydrochloride Market Size, Share and Forecast[1].
  2. Market Research Intellect: Global Daunorubicin Hydrochloride (CAS 23541-50-6) Sales Market[2].
  3. Market Research Intellect: Cytarabine And Daunorubicin Market Size and Projections[3].
  4. Data Horizon Research: Daunorubicin Hydrochloride Market Size, Growth and Analysis Report[4].

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