Quizartinib dihydrochloride - Generic Drug Details

What are the generic sources for quizartinib dihydrochloride and what is the scope of freedom to operate?

Quizartinib dihydrochloride is the generic ingredient in one branded drug marketed by Daiichi Sankyo Inc and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Quizartinib dihydrochloride has one hundred and twenty-four patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for quizartinib dihydrochloride

International Patents:	124
US Patents:	11
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	41
DailyMed Link:	quizartinib dihydrochloride at DailyMed

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

Constraining patent/regulatory exclusivity:

FOR USE IN COMBINATION WITH STANDARD INDUCTION AND CONSOLIDATION, AND AS MAINTENANCE THERAPY FOLLOWING CONSOLIDATION CHEMOTHERAPY, FOR THE TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) THAT IS FLT3 INTERNAL TANDEM DUPLICATION (ITD)-POSITIVE AS DETECTED BY AN FDA-APPROVED TEST

Dosage:

TABLET;ORAL

^*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 quizartinib dihydrochloride

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

Sponsor	Phase
M.D. Anderson Cancer Center	PHASE1
Daiichi Sankyo	PHASE3
Daiichi Sankyo	PHASE1

See all quizartinib dihydrochloride clinical trials

Pharmacology for quizartinib dihydrochloride

Drug Class	Kinase Inhibitor
Mechanism of Action	FMS-like Receptor Tyrosine Kinase 3 (FLT3) Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for quizartinib dihydrochloride

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for quizartinib dihydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-002	Jul 20, 2023		RX	Yes	Yes			Y
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-002	Jul 20, 2023		RX	Yes	Yes			Y
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-002	Jul 20, 2023		RX	Yes	Yes			Y
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-002	Jul 20, 2023		RX	Yes	Yes				Y
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-002	Jul 20, 2023		RX	Yes	Yes

International Patents for quizartinib dihydrochloride

Country	Patent Number	Title	Estimated Expiration
China	102438588	Methods of treatment using combination therapy
Israel	215131	תערובת של תרכובות לשימוש בתרפיה (Mixture of compounds for therapeutic use)
Croatia	P20131083
South Korea	101578481
Russian Federation	2011142750	СПОСОБ ЛЕЧЕНИЯ ПУТЕМ ПРИМЕНЕНИЯ КОМБИНИРОВАННОЙ ТЕРАПИИ

Supplementary Protection Certificates for quizartinib dihydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2429524	CR 2024 00013	Denmark		PRODUCT NAME: QUIZARTINIB; REG. NO/DATE: EU/1/23/1768 20231107
2429524	2490010-2	Sweden		PRODUCT NAME: QUIZARTINIB; REG. NO/DATE: EU/1/23/1768 20231107
2429524	2024C/514	Belgium		PRODUCT NAME: QUIZARTINIB; AUTHORISATION NUMBER AND DATE: EU/1/23/1768 20231107
2429524	LUC00338	Luxembourg		PRODUCT NAME: QUIZARTINIB; AUTHORISATION NUMBER AND DATE: EU/1/23/1768 20231107
2410987	24C1013	France		PRODUCT NAME: QUIZARTINIB; REGISTRATION NO/DATE: EU/1/23/1768 20231107

Market Dynamics and Financial Trajectory for Quizartinib Dihydrochloride

Last updated: October 17, 2025

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Introduction

Quizartinib Dihydrochloride (hereafter referred to as Quizartinib) is an emerging targeted therapy developed for acute myeloid leukemia (AML), specifically for patients harboring FLT3 mutations, which are associated with aggressive disease progression and poor prognosis. As a potent FLT3 inhibitor, Quizartinib has garnered significant attention within the oncology community and the pharmaceutical market due to its promising clinical results and strategic positioning. This article evaluates the current market dynamics and projects the financial trajectory of Quizartinib, taking into account regulatory developments, competitive landscape, pipeline prospects, and market-entry strategies.

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Market Overview and Demand Drivers

The global AML therapeutics market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 7.5% from 2022 to 2030, driven by increasing incidence rates, advancements in targeted therapies, and improved diagnostic accuracy [1]. Among these, FLT3-mutated AML accounts for roughly 30% of adult AML cases, representing a substantial segment for targeted interventions [2].

Advancements in molecular profiling have facilitated the identification of FLT3 mutations such as internal tandem duplications (ITD), which are linked to higher relapse rates and mortality. Consequently, there is a growing demand for FLT3 inhibitors like Quizartinib, which offers a targeted approach with the potential for improved remission rates and survival outcomes.

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Regulatory Landscape and Market Entry

Regulatory Status:
Initially, Quizartinib received Fast Track designation from the U.S. Food and Drug Administration (FDA) in 2018 for relapsed/refractory FLT3-ITD AML—signaling its potential to address unmet medical needs. However, the drug has faced hurdles; in 2021, the FDA issued a Complete Response Letter (CRL) citing insufficient evidence of overall survival benefit from the pivotal trials [3]. Despite this, regulatory agencies in other regions, such as Japan, have approved Quizartinib (Rucaparib) based on phase II data with a focus on safety and efficacy profiles.

Market Approval and Commercialization Strategy:
The partial regulatory success necessitates strategic repositioning. Developers are now focusing on combination therapies, earlier lines of treatment, and refined patient selection to enhance clinical outcomes and align with regulatory expectations. As of 2023, commercial launch efforts are concentrated in Asian markets and select U.S. institutions with ongoing clinical collaborations.

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Competitive Landscape

Key Competitors:

• Gilteritinib (Xospata): FDA-approved FLT3 inhibitor with demonstrated overall survival benefit in relapsed AML spectrum.
• Midostaurin (Rydapt): Approved for newly diagnosed FLT3-mutated AML when combined with chemotherapy.
• Gilteritinib's Advantages: Greater clinical data supporting survival benefits and broader approval status increase its market share.

Quizartinib’s Differentiation Factors:
Its high specificity for FLT3-ITD mutations and potential for better tolerability could position Quizartinib favorably if clinical outcomes are validated in ongoing trials. Its efficacy in patients resistant to other FLT3 inhibitors and emerging data supporting combination regimens will further bolster its market position.

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Pipeline and Clinical Development

Quizartinib's pipeline focuses on:

• Combination therapies: Trials combining Quizartinib with standard chemotherapy, hypomethylating agents, or other targeted drugs aim to improve response durability.
• Earlier line of therapy: Investigating efficacy in newly diagnosed patients to expand indications and capture a broader market share.
• Resistance management: Addressing secondary mutations and resistance mechanisms through next-generation FLT3 inhibitors.

Notably, ongoing Phase III trials are pivotal in demonstrating overall survival benefits, a critical factor for regulatory approval and market acceptance. The commercialization potential hinges on the timely success of these trials.

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Financial Trajectory and Market Forecasts

Revenue Streams:
Primary revenue for Quizartinib originates from licensing agreements, direct sales (if marketed independently), and strategic partnerships.

Market Projections:
Analysts estimate that if regulatory hurdles are surmounted, Quizartinib could command a peak global sales figure between $500 million and $1 billion by 2028, driven by:

• Rapid adoption in regions with unmet needs.
• Expansion into frontline therapy for suitable patients.
• Strategic collaborations with large oncology-focused pharmaceutical firms.

Pricing Strategy:
Targeted therapies for AML have typically been priced between $15,000 and $30,000 per month, contingent upon region and indication. Given its specificity and potential clinical advantages, Quizartinib’s pricing could align with this range, especially if outcomes surpass existing FLT3 inhibitors.

Market Challenges:
Cost reimbursement frameworks, competition from established drugs such as Gilteritinib, and uncertainties surrounding regulatory approvals will influence the financial outlook.

Investment Insights:
Early-stage investors and pharma companies should monitor ongoing trial results, regulatory communications, and regional approval pathways to assess risk-adjusted returns. Partnering with or acquiring rights to Quizartinib may be advantageous for firms targeting AML and precision oncology markets.

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Impact of Market Dynamics on Financial Trajectory

• Regulatory Approvals:
  Successful approvals, especially for first-line treatment, could significantly amplify sales; failure or delays could cap upside potential.

• Technological and Clinical Advances:
  Improved diagnostic techniques and personalized medicine will support targeted drug adoption. Conversely, competition from next-generation FLT3 inhibitors and evolving treatment paradigms may limit market penetration.

• Strategic Partnerships:
  Licensing, co-development, and commercialization agreements are crucial for resource enhancement and global reach, impacting revenue streams.

• Market Penetration and Adoption:
  Physician and patient acceptance driven by clinical data, safety profile, and cost will heavily influence revenue growth.

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Conclusion: Strategic Considerations for Stakeholders

The financial trajectory of Quizartinib hinges on overcoming regulatory challenges through robust clinical data, especially demonstrating a clear survival benefit. Its market dynamics are shaped by existing competition, the evolving AML treatment landscape, and regulatory environments worldwide. Strategic partnerships and early adoption in regional markets may serve as catalysts for revenue growth, with blockbuster potential contingent on successful phase III outcomes and regulatory approvals.

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Key Takeaways

• Quizartinib targets a niche within the AML market, with significant growth potential if regulatory and clinical hurdles are addressed.
• Competition from Gilteritinib and Midostaurin underscores the need for demonstrating superior efficacy or safety.
• Pipeline advancements, particularly in combination therapies and earlier-line applications, could broaden its market reach.
• Regulatory success — particularly in major markets like the U.S. — remains a critical determinant of financial success.
• Strategic collaborations and regional market penetration are essential components of its revenue model.

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FAQs

1. What are the primary clinical advantages of Quizartinib over existing FLT3 inhibitors?
Quizartinib exhibits high specificity for FLT3-ITD mutations and has shown promising activity in resistant cases, potentially offering better tolerability and efficacy. However, definitive long-term survival benefits remain to be fully demonstrated through phase III trials.

2. How does regulatory uncertainty impact the market potential of Quizartinib?
Regulatory setbacks or delays reduce investor confidence and slow commercialization, limiting revenue growth. Conversely, positive trial results and regulatory approval can significantly accelerate market entry and sales.

3. What regions represent the most lucrative opportunities for Quizartinib?
The United States and Japan currently offer the most promising markets due to high AML prevalence, advanced healthcare infrastructure, and ongoing trial activities. Emerging markets in Europe and Asia also represent long-term growth avenues.

4. How might competition evolve in the FLT3 inhibitor space over the next five years?
Next-generation FLT3 inhibitors with enhanced efficacy, reduced resistance, or combination strategies are likely to emerge, intensifying competition. Continuous innovation and compelling clinical data are necessary for Quizartinib to maintain market relevance.

5. What strategic actions should stakeholders consider to maximize Quizartinib’s market potential?
Forming partnerships for clinical development, focusing on early-line indications, investing in real-world evidence, and engaging proactively with regulatory agencies will be critical for expanding market access and accelerating revenue streams.

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Sources

[1] Reports and market analyses from GlobalData, 2022.
[2] National Cancer Institute, SEER Database, 2022.
[3] FDA Complete Response Letter, 2021.