DAUNORUBICIN HYDROCHLORIDE - Generic Drug Details

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

Daunorubicin hydrochloride is the generic ingredient in two branded drugs marketed by Hikma, Sanofi Aventis Us, Wyeth Ayerst, Fresenius Kabi Usa, Hisun Pharm Hangzhou, Meitheal, and Teva Parenteral, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for daunorubicin hydrochloride. Two suppliers are listed for this compound.

Summary for DAUNORUBICIN HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	10
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	374
Patent Applications:	7,324
What excipients (inactive ingredients) are in DAUNORUBICIN HYDROCHLORIDE?	DAUNORUBICIN HYDROCHLORIDE excipients list
DailyMed Link:	DAUNORUBICIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DAUNORUBICIN HYDROCHLORIDE

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

Sponsor	Phase
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.	Phase 3
Uwe Platzbecker	Phase 2
Gilead Sciences	Phase 2

See all DAUNORUBICIN HYDROCHLORIDE clinical trials

Pharmacology for DAUNORUBICIN HYDROCHLORIDE

Drug Class	Anthracycline Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DAUNORUBICIN HYDROCHLORIDE

L01DB	Anthracyclines and related substances
L01D	CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
Fresenius Kabi Usa	DAUNORUBICIN HYDROCHLORIDE	daunorubicin hydrochloride	INJECTABLE;INJECTION	065000-001	May 25, 1999	AP	RX	No	No
Hikma	CERUBIDINE	daunorubicin hydrochloride	INJECTABLE;INJECTION	064103-001	Feb 3, 1995	AP	RX	No	Yes
Hisun Pharm Hangzhou	DAUNORUBICIN HYDROCHLORIDE	daunorubicin hydrochloride	INJECTABLE;INJECTION	208759-001	Apr 12, 2019	AP	RX	No	No

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].