~ Buy the VYXEOS (cytarabine; daunorubicin) Drug Profile, 2024 PDF Report in the Report Store ~

VYXEOS Drug Patent Profile

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

Vyxeos is a drug marketed by Celator Pharms and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and forty-five patent family members in twenty-six countries.

The generic ingredient in VYXEOS is cytarabine; daunorubicin. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cytarabine; daunorubicin profile page.

DrugPatentWatch^® Generic Entry Outlook for Vyxeos

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 30, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VYXEOS

International Patents:	145
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	47
Patent Applications:	76
Drug Prices:	Drug price information for VYXEOS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VYXEOS
What excipients (inactive ingredients) are in VYXEOS?	VYXEOS excipients list
DailyMed Link:	VYXEOS at DailyMed

See drug prices for VYXEOS

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VYXEOS

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

NDA:

209401

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 VYXEOS

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

Sponsor	Phase
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.	Phase 3
Eastern Cooperative Oncology Group	Phase 2
St. Jude Children's Research Hospital	Phase 2

See all VYXEOS clinical trials

Pharmacology for VYXEOS

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

US Patents and Regulatory Information for VYXEOS

VYXEOS is protected by ten US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on 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.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	8,022,279		Y
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes	8,431,806		Y
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes	10,028,912		Y
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes

EU/EMA Drug Approvals for VYXEOS

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

International Patents for VYXEOS

See the table below for patents covering VYXEOS around the world.

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)
Japan	2010018632	LIPID CARRIER COMPOSITION HAVING ENHANCED STABILITY IN BLOOD
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)
Canada	2467064	COMPOSITIONS A VECTEURS LIPIDIQUES A STABILITE SANGUINE ACCRUE (LIPID CARRIER COMPOSITIONS WITH ENHANCED BLOOD STABILITY)

Supplementary Protection Certificates for VYXEOS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2768484	53/2019	Austria		PRODUCT NAME: KOMBINATION VON DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 (MITTEILUNG) 20180827
1744764	2018/042	Ireland		PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180823
1744764	46/2018	Austria		PRODUCT NAME: KOMBINATION VON DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 (MITTEILUNG) 20180827
2768484	C20190039 00312	Estonia		PRODUCT NAME: DAUNORUBITSIIN/TSUETARABIIN;REG NO/DATE: EU/1/18/1308 27.08.2018

VYXEOS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Vyxeos

Introduction to Vyxeos

Vyxeos, a liposomal formulation of daunorubicin and cytarabine, is a significant treatment option for adults with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Here, we delve into the market dynamics and financial trajectory of Vyxeos.

Clinical Significance and Efficacy

Vyxeos has demonstrated clinical efficacy in prolonging life and improving remission rates in patients with t-AML or AML-MRC compared to conventional cytarabine and daunorubicin (7 + 3) regimens. This is crucial as these subtypes of AML have a worse prognosis and limited treatment options[4].

Market Size and Growth

The global market for Vyxeos is part of the broader acute myeloid leukemia (AML) market, which is expected to grow at a CAGR of more than 4% from 2022 to 2032. This growth is driven by the increasing number of AML patients and the introduction of new therapies[3].

Revenue Performance

Jazz Pharmaceuticals, the manufacturer of Vyxeos, reported significant revenue growth from the drug. In 2023, Vyxeos generated $147.5 million in revenue, up from $127.9 million in 2022. This represents a year-over-year increase, contributing to the overall growth of Jazz Pharmaceuticals' oncology segment[2][5].

Segment Contribution

Vyxeos is a key component of Jazz Pharmaceuticals' oncology portfolio, which also includes other drugs like Zepzelca and Defitelio. The total oncology segment revenue for Jazz Pharmaceuticals was $1.015 billion in 2023, with Vyxeos contributing approximately 14.5% to this total[2][5].

Regional Analysis

The market for Vyxeos is predominantly driven by regions with high healthcare spending and advanced oncology treatment options. The US, UK, Germany, France, Italy, Spain, Japan, and urban China are key markets for AML treatments, including Vyxeos[3].

Cost-Effectiveness and Pricing

Despite its clinical benefits, Vyxeos faces challenges related to cost-effectiveness. The incremental cost-effectiveness ratio (ICER) for Vyxeos compared to the 7 + 3 regimen is $110,283 per quality-adjusted life-year (QALY), which is not considered cost-effective at a $50,000 per QALY willingness-to-pay threshold. A price reduction of at least 68% would be necessary for Vyxeos to be considered cost-effective[4].

Competitive Landscape

The AML market is competitive, with various drug classes including targeted therapies, cell therapies, and branded and generic chemotherapies. Vyxeos competes with other treatments such as FLAG-IDA and midostaurin, and the market is expected to see the launch of new therapies like menin inhibitors and radiopharmaceuticals[3].

Financial Guidance and Projections

Jazz Pharmaceuticals' financial performance, including Vyxeos, is part of the company's overall growth strategy. With total revenues of $3.8 billion in 2023 and a 27% year-over-year revenue increase, the company is poised for continued growth. The non-GAAP adjusted net income for 2023 was $1.295 billion, indicating strong financial health[2][5].

Market Drivers and Opportunities

• Increasing Patient Population: The growing number of AML patients drives the demand for effective treatments like Vyxeos.
• New Therapies: The introduction of new therapies and pipeline agents, such as menin inhibitors and radiopharmaceuticals, expands the market segment.
• Improving HSCT Outcomes: Agents aimed at improving hematopoietic stem cell transplantation (HSCT) outcomes create new market opportunities[3].

Market Restraints

• Cost-Effectiveness: The high cost of Vyxeos compared to traditional treatments is a significant restraint.
• Side Effects: Current treatments, including Vyxeos, are associated with side effects, which can impact patient compliance and quality of life.
• Competition: The competitive landscape with various drug classes and upcoming therapies poses a challenge to Vyxeos' market share[4].

Technological and Regulatory Trends

• Innovative Formulations: The liposomal formulation of Vyxeos is an example of innovative drug delivery systems that enhance efficacy and reduce side effects.
• Regulatory Approvals: Continuous regulatory approvals and updates are crucial for maintaining market presence and expanding indications[4].

Consumer Behavior and Preferences

Patients and healthcare providers increasingly prioritize treatments that not only prolong survival but also maintain remission and have an acceptable side-effect profile. Vyxeos, with its improved efficacy over conventional treatments, aligns with these preferences but faces challenges due to its high cost[4].

Key Takeaways

• Clinical Efficacy: Vyxeos has demonstrated improved efficacy in treating t-AML and AML-MRC.
• Revenue Growth: Vyxeos has contributed significantly to Jazz Pharmaceuticals' revenue growth.
• Cost-Effectiveness: Despite clinical benefits, Vyxeos faces cost-effectiveness challenges.
• Market Dynamics: The AML market is driven by increasing patient numbers and new therapies.
• Competitive Landscape: Vyxeos competes with various drug classes and upcoming therapies.

FAQs

What is Vyxeos used for?

Vyxeos is used for the treatment of adults with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

How does Vyxeos compare to conventional treatments?

Vyxeos has shown improved efficacy in prolonging life and improving remission rates compared to conventional cytarabine and daunorubicin (7 + 3) regimens.

What are the cost-effectiveness challenges faced by Vyxeos?

Vyxeos is not considered cost-effective at a $50,000 per QALY willingness-to-pay threshold, with an ICER of $110,283 per QALY compared to the 7 + 3 regimen.

Which regions are key markets for Vyxeos?

The key markets for Vyxeos include the US, UK, Germany, France, Italy, Spain, Japan, and urban China.

What is the revenue performance of Vyxeos?

In 2023, Vyxeos generated $147.5 million in revenue, up from $127.9 million in 2022, contributing to the overall growth of Jazz Pharmaceuticals' oncology segment.

Sources

1. Global Vyxeos Market Report 2024 Edition - Cognitivemarketresearch.com
2. Jazz Pharmaceuticals Announces Full Year and Fourth Quarter 2023 Financial Results - Prnewswire.com
3. Acute Myeloid Leukemia (AML) Market Report Overview - GlobalData
4. Daunorubicin and Cytarabine (Vyxeos) - Canada's Drug Agency
5. Jazz Pharmaceuticals Announces Full Year and Fourth Quarter 2023 Financial Results - Investor.jazzpharma.com