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Last Updated: December 22, 2024

Cytarabine; daunorubicin - Generic Drug Details

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What are the generic drug sources for cytarabine; daunorubicin and what is the scope of freedom to operate?

Cytarabine; daunorubicin is the generic ingredient in one branded drug marketed by Celator Pharms and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cytarabine; daunorubicin has one hundred and forty-five patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for cytarabine; daunorubicin

International Patents:	145
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	280
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cytarabine; daunorubicin
DailyMed Link:	cytarabine; daunorubicin at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cytarabine; daunorubicin

Generic Entry Date for cytarabine; daunorubicin^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PEDIATRIC PATIENTS AGES 1 YEAR AND OLDER Dosage: POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for cytarabine; daunorubicin

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 cytarabine; daunorubicin clinical trials

Pharmacology for cytarabine; daunorubicin

Drug Class	Anthracycline Topoisomerase Inhibitor Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors Topoisomerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for cytarabine; daunorubicin

US Patents and Regulatory Information for cytarabine; daunorubicin

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes	10,028,912	⤷ Subscribe	Y			⤷ Subscribe
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes	8,022,279	⤷ Subscribe	Y			⤷ Subscribe
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes	8,431,806	⤷ Subscribe	Y			⤷ Subscribe
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes	8,518,437	⤷ Subscribe	Y			⤷ Subscribe
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes	10,835,492	⤷ Subscribe				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for cytarabine; daunorubicin

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Jazz Pharmaceuticals Ireland Limited	Vyxeos liposomal (previously known as Vyxeos)	daunorubicin, cytarabine	EMEA/H/C/004282 Vyxeos liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).	Authorised	no	no	yes	2018-08-23
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for cytarabine; daunorubicin

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1448165	COMPOSITIONS A VECTEURS LIPIDIQUES ET PROCEDES GARANTISSANT UNE MEILLEURE RETENTION MEDICAMENTEUSE (LIPID CARRIER COMPOSITIONS AND METHODS FOR IMPROVED DRUG RETENTION)	⤷ Subscribe
Japan	2010018632	LIPID CARRIER COMPOSITION HAVING ENHANCED STABILITY IN BLOOD	⤷ Subscribe
European Patent Office	3300601	RAPPORTS DE MÉDICAMENT FIXES POUR LE TRAITEMENT DES CANCERS HÉMATOPOÏÉTIQUES ET DES TROUBLES PROLIFÉRATIFS (FIXED DRUG RATIOS FOR TREATMENT OF HEMATOPOIETIC CANCERS AND PROLIFERATIVE DISORDERS)	⤷ Subscribe
Canada	2467064	COMPOSITIONS A VECTEURS LIPIDIQUES A STABILITE SANGUINE ACCRUE (LIPID CARRIER COMPOSITIONS WITH ENHANCED BLOOD STABILITY)	⤷ Subscribe
Japan	4972545		⤷ Subscribe
Spain	2650167		⤷ Subscribe
Portugal	1744764		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for cytarabine; daunorubicin

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2768484	53/2019	Austria	⤷ Subscribe	PRODUCT NAME: KOMBINATION VON DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 (MITTEILUNG) 20180827
1744764	2018/042	Ireland	⤷ Subscribe	PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180823
1744764	46/2018	Austria	⤷ Subscribe	PRODUCT NAME: KOMBINATION VON DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 (MITTEILUNG) 20180827
2768484	C20190039 00312	Estonia	⤷ Subscribe	PRODUCT NAME: DAUNORUBITSIIN/TSUETARABIIN;REG NO/DATE: EU/1/18/1308 27.08.2018
2768484	132019000000144	Italy	⤷ Subscribe	PRODUCT NAME: DAUNORUBICINA E CITARABINA(VYXEOS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1308, 20180827
1744764	C01744764/01	Switzerland	⤷ Subscribe	PRODUCT NAME: DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68014 17.02.2022
2768484	2019/054	Ireland	⤷ Subscribe	PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Cytarabine; daunorubicin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cytarabine and Daunorubicin

Introduction to Cytarabine and Daunorubicin

Cytarabine and daunorubicin are two critical chemotherapeutic agents used primarily in the treatment of acute myeloid leukemia (AML) and other hematologic malignancies. These drugs have been integral in oncology for decades, and their market dynamics are influenced by several key factors.

Market Size and Growth Projections

The global market for cytarabine and daunorubicin was valued at USD 128 million in 2023 and is projected to grow to USD 184 million by 2031, with a Compound Annual Growth Rate (CAGR) of 5.3% during the forecast period of 2024-2031[3][4].

Key Drivers of Market Growth

Increasing Prevalence of Blood Malignancies

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

Advances in Clinical Research and Combination Therapies

Advances in clinical research have led to the development of more effective combination therapies involving cytarabine and daunorubicin. These advancements, such as the formulation of liposomal daunorubicin and cytarabine (Vyxeos), have improved the efficacy and reduced the side effects of these medications, further driving market growth[2][3].

Growing Emphasis on Personalized Medicine

The increasing emphasis on personalized and targeted therapy is another key driver. As healthcare moves towards more tailored treatment approaches, the demand for drugs like cytarabine and daunorubicin, which can be part of customized treatment regimens, is expected to rise[1][3].

Investment in Oncology Research

Significant investments in oncology research and the development of healthcare infrastructure in emerging markets are also contributing to the growth of the cytarabine and daunorubicin market. These investments facilitate better access to these medications and drive innovation in treatment protocols[3][4].

Market Challenges and Limitations

Regulatory Framework

One of the significant challenges facing the cytarabine and daunorubicin market is the absence of a predefined regulatory framework. This lack of clear regulations can hinder the approval and adoption of new formulations and treatment protocols[1].

Cost-Effectiveness and Pricing

The cost-effectiveness of liposomal daunorubicin and cytarabine, such as Vyxeos, is a critical issue. Studies have shown that these formulations are not cost-effective at current prices compared to conventional treatments like the 7 + 3 regimen. A price reduction of at least 68% would be necessary for Vyxeos to be considered cost-effective at a willingness-to-pay threshold of $50,000 per quality-adjusted life-year (QALY)[2].

Geographical Market Overview

The global cytarabine and daunorubicin market is segmented geographically into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America has been at the forefront in terms of growth opportunities and developments in this field, largely due to the presence of several pharmaceutical and biosciences companies and leading players in the market[1].

Competitive Landscape

The market for cytarabine and daunorubicin is moderately consolidated, with a few key players holding leading positions. Companies like Jazz Pharma and Celator Pharmaceuticals are prominent in this market. These players are expected to engage in strategic partnerships to maintain their competitive edge[1].

Financial Implications and Budget Impact

The financial implications of incorporating drugs like Vyxeos into treatment protocols are significant. For instance, the estimated 3-year budget impact of covering the costs of Vyxeos through cancer funding programs is approximately $34,304,171. The cost per vial of Vyxeos is $7,774, with each vial containing 44 mg of daunorubicin and 100 mg of cytarabine. The total cost for a 28-day cycle can range from $46,642 for the first induction to $31,094 for subsequent inductions and consolidations[2].

Clinical Efficacy and Patient Outcomes

Clinical studies have demonstrated the efficacy of liposomal daunorubicin and cytarabine in improving overall survival rates and reducing the risk of death compared to conventional treatments. For example, patients treated with Vyxeos showed a median overall survival of 9.56 months compared to 5.95 months for those treated with the 7 + 3 regimen, with a 31% lower risk of death[2].

Future Outlook and Opportunities

The future outlook for the cytarabine and daunorubicin market is promising, driven by ongoing research and development, increasing awareness of early diagnosis, and the growing need for effective treatments for hematologic malignancies. The advent of cost-effective lab tests and integrated analytical systems, as well as a growing preference for point-of-care testing and personalized medicine, are expected to open new opportunities for market growth[1].

Key Takeaways

The global cytarabine and daunorubicin market is projected to grow from USD 128 million in 2023 to USD 184 million by 2031.
Key drivers include the increasing prevalence of blood malignancies, advances in clinical research, and growing emphasis on personalized medicine.
Challenges such as regulatory frameworks and cost-effectiveness need to be addressed.
North America is a leading region in terms of market growth and developments.
Clinical efficacy of liposomal formulations like Vyxeos has shown improved patient outcomes.

FAQs

Q: What is the projected growth rate of the cytarabine and daunorubicin market?

A: The market is expected to grow at a CAGR of 5.3% from 2024 to 2031[3][4].

Q: Which regions are leading in the cytarabine and daunorubicin market?

A: North America is currently at the forefront in terms of growth opportunities and developments[1].

Q: What are the key drivers of the cytarabine and daunorubicin market?

A: Key drivers include the increasing prevalence of blood malignancies, advances in clinical research, and a growing emphasis on personalized medicine[1][3].

Q: Is liposomal daunorubicin and cytarabine cost-effective compared to conventional treatments?

A: No, liposomal daunorubicin and cytarabine are not considered cost-effective at current prices and would require a significant price reduction to meet cost-effectiveness thresholds[2].

Q: Which companies are prominent players in the cytarabine and daunorubicin market?

A: Companies like Jazz Pharma and Celator Pharmaceuticals are prominent players in this market[1].

Sources

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.