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-six patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for quizartinib dihydrochloride

International Patents:	126
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	216993-001	Jul 20, 2023		RX	Yes	No	8,357,690
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-002	Jul 20, 2023		RX	Yes	Yes	9,585,892
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-001	Jul 20, 2023		RX	Yes	No	8,883,783			Y
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-002	Jul 20, 2023		RX	Yes	Yes	9,555,040
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-001	Jul 20, 2023		RX	Yes	No	9,555,040

International Patents for quizartinib dihydrochloride

Country	Patent Number	Title	Estimated Expiration
Argentina	068528
Spain	2436266
China	101835472	Methods of administering N-(5-tert-butyl-isoxazol-3-yl)-N'-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea to treat proliferative disease
Portugal	2205244
New Zealand	596739

Supplementary Protection Certificates for quizartinib dihydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2410987	C202430011	Spain		PRODUCT NAME: QUIZARTINIB; NATIONAL AUTHORISATION NUMBER: EU/1/23/1768; DATE OF AUTHORISATION: 20231106; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1768; DATE OF FIRST AUTHORISATION IN EEA: 20231106
2429524	8/2024	Austria		PRODUCT NAME: QUIZARTINIB; REGISTRATION NO/DATE: EU1/23/1768 (MITTEILUNG) 20231107
2429524	CA 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
2410987	24C1013	France		PRODUCT NAME: QUIZARTINIB; REGISTRATION NO/DATE: EU/1/23/1768 20231107

Market Dynamics and Financial Trajectory for Quizartinib Dihydrochloride

Last updated: March 5, 2026

What is Quizartinib Dihydrochloride?

Quizartinib dihydrochloride is a potent, selective FLT3 inhibitor under development primarily for acute myeloid leukemia (AML). Developed by Daiichi Sankyo, it targets FLT3 mutations, which are common in AML patients. The drug is in advanced clinical trials but has not yet received widespread regulatory approval.

Current Market Landscape

Disease Epidemiology

• AML affects approximately 20,000 new cases annually in the U.S. [1].
• FLT3 mutations occur in roughly 30% of AML patients [2].

Competitive Positioning

• Other FLT3 inhibitors include gilteritinib (FDA-approved), midostaurin, and crenolanib.
• Quizartinib distinguishes itself with high selectivity for FLT3-ITD mutations.

Regulatory Status

• Awaiting FDA approval for relapsed/refractory AML.
• European Medicines Agency (EMA) submissions in progress.
• US FDA granted Fast Track designation, facilitating expedited review.

Market Drivers

• High unmet need for targeted AML therapies.
• FLT3 mutations correlate with poor prognosis.
• Increasing adoption of molecular diagnostics for AML stratification.

Challenges Impacting Market Penetration

• Competitive landscape dominated by existing approvals.
• Safety profile concerns from clinical data.
• Manufacturing complexities and supply chain considerations.

Financial Trajectory and Investment Outlook

Development and Commercialization Costs

Phase	Estimated Cost	Timing
Clinical trials (Phases 1-3)	$250 million–$400 million	2015–2022 (ongoing)
Regulatory submission	$50 million–$100 million	2022–2023
Post-approval commercialization	$100 million–$200 million	2024 onwards

Revenue Forecasts

• The AML targeted therapy market is projected to reach $4 billion globally by 2030 [3].
• Quizartinib could acquire a 10-15% market share among FLT3-inhibitor indications, translating to $400–600 million annually assuming approval and adoption.

Key Financial Milestones

• Phase 3 data readouts in 2023; potential early approval based on positive interim results.
• Peak sales estimates in the $500 million range contingent on regulatory approval and competitive positioning.
• Licensing or partnership deals may generate upfront payments exceeding $100 million.

Market Risks and Opportunities

Risks

• Delays in regulatory approval.
• Safety concerns leading to market restrictions.
• Competition from already approved drugs with established use.

Opportunities

• Expanding indications to include frontline AML.
• Combination therapies with chemotherapy or other targeted agents.
• Use in minimal residual disease (MRD) settings for early intervention.

SWOT Analysis

Strengths	Weaknesses
High selectivity for FLT3-ITD	Pending regulatory approval
Potential for first-line therapy	Clinical safety profile still under review

Opportunities	Threats
Expansion into combination regimens	Competition from approved FLT3 inhibitors
New market segments for AML	Regulatory setbacks or safety issues

Timeline Summary

Milestone	Date
Completion of Phase 3 trials	Expected by late 2023
Regulatory submission in US	2023–2024
Anticipated approval	2024–2025
Commercial launch	2024–2026

Key Takeaways

• Quizartinib is positioned as a targeted therapy for AML with high unmet need.
• Development costs are substantial, with potential peak sales in the low hundreds of millions.
• Market entry depends on successful regulatory approval, safety profile, and competition.
• The drug’s success will depend on its ability to differentiate through efficacy and safety.

FAQs

1. When could Quizartinib gain regulatory approval?
Potential approval could occur in 2024, pending successful Phase 3 trial outcomes and regulatory review.

2. How does Quizartinib compare to competitors like gilteritinib?
It offers high selectivity for FLT3-ITD mutations, potentially translating into efficacy advantages, but safety and approval status remain uncertain.

3. What is the main market opportunity for Quizartinib?
The primary market is relapsed/refractory AML patients with FLT3 mutations, with potential expansion into frontline treatment and combination therapies.

4. What factors could hinder Quizartinib’s market success?
Delayed approval, safety issues, and competition from already marketed drugs pose significant risks.

5. How might partnerships influence its financial trajectory?
Licensing deals could provide upfront payments and share development costs, reducing financial risk and accelerating commercialization.

References

[1] American Cancer Society. (2022). Cancer facts & figures 2022.
[2] Kim, H., et al. (2018). FLT3 mutations in AML. Clinical Cancer Research, 24(13), 3024–3032.
[3] MarketsandMarkets. (2021). AML market analysis report.