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 nineteen patent family members in twenty-nine countries.

One supplier is listed for this compound.

Summary for QUIZARTINIB DIHYDROCHLORIDE

International Patents:	119
US Patents:	11
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	33
Patent Applications:	62
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
French Innovative Leukemia Organisation	Phase 2
Acute Leukemia French Association	Phase 2
University Hospital Heidelberg	Phase 3

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				Y
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-002	Jul 20, 2023		RX	Yes	Yes
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-002	Jul 20, 2023		RX	Yes	Yes			Y

International Patents for QUIZARTINIB DIHYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Cyprus	1117583
World Intellectual Property Organization (WIPO)	2014055397
South Korea	20120000567	METHODS OF TREATMENT USING COMBINATION THERAPY

Supplementary Protection Certificates for QUIZARTINIB DIHYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2429524	301265	Netherlands		PRODUCT NAME: QUIZARTINIB; REGISTRATION NO/DATE: EU/1/23/1768 20231107
2429524	PA2024510	Lithuania		PRODUCT NAME: KVIZARTINIBAS; REGISTRATION NO/DATE: EU/1/23/1768 20231106
2429524	CA 2024 00013	Denmark		PRODUCT NAME: QUIZARTINIB; REG. NO/DATE: EU/1/23/1768 20231107

QUIZARTINIB DIHYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Quizartinib Dihydrochloride

Introduction

Quizartinib dihydrochloride, marketed under the brand name Vanflyta, is a groundbreaking oral FLT3 inhibitor developed by Daiichi Sankyo. It has been approved for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive. Here, we delve into the market dynamics and financial trajectory of this significant therapeutic advancement.

Regulatory Approvals and Market Expansion

Quizartinib has received pivotal regulatory approvals that have significantly impacted its market dynamics. In July 2023, the FDA approved quizartinib for use in combination with standard chemotherapy for newly diagnosed FLT3-ITD positive AML, based on the positive results from the QuANTUM-First trial[4].

Additionally, quizartinib has been recommended for approval in the European Union by the Committee for Medicinal Products for Human Use (CHMP) for similar indications, marking a crucial step towards its global market expansion[1].

Clinical Efficacy and Market Impact

The QuANTUM-First trial demonstrated a statistically significant improvement in overall survival (OS) for patients treated with quizartinib compared to those receiving placebo, with a hazard ratio of 0.78 and a 22% reduction in the risk of death[4].

This clinical efficacy has positioned quizartinib as a valuable addition to the current AML treatment regimen, particularly for patients with FLT3-ITD mutations, which are associated with a poorer prognosis and higher risk of relapse[5].

Cost-Effectiveness and Health Economic Implications

While quizartinib offers significant clinical benefits, its cost-effectiveness is a critical factor in its market adoption. A study evaluating the cost-effectiveness of adding quizartinib to standard induction chemotherapy revealed that the incremental cost was substantial, with an incremental cost-effectiveness ratio of $344,039 per quality-adjusted life year (QALY)[3].

However, the study also suggested that reducing the average wholesale price of quizartinib or omitting its continuation therapy after consolidation and allogeneic hematopoietic cell transplant could make it a more cost-effective option[3].

Market Share and Competitive Landscape

Quizartinib's approval and positive clinical outcomes have enabled it to capture a significant share in the AML treatment market. As the first drug specifically developed to target FLT3-ITD mutations, it fills a critical gap in the treatment options for AML patients.

Daiichi Sankyo's strategic collaborations and robust clinical development program further enhance quizartinib's market position. The company's other successful products, such as Enhertu, also contribute to its overall market strength and financial stability[2].

Financial Performance and Projections

Daiichi Sankyo's financial performance has been positively impacted by the approval and sales of quizartinib. The company's Q2 2023 financial results showed an increase in revenue, partly attributed to the success of its oncology portfolio, including quizartinib[2].

For FY2023, Daiichi Sankyo forecasts continued growth, with projected revenue and core operating profit increases. The company's financial health is also bolstered by its cost-sharing agreements and collaborations, such as the one with Merck & Co., Inc., for several ADC products[2].

Revenue and Sales Projections

The approval of quizartinib in key markets is expected to drive significant revenue growth for Daiichi Sankyo. The drug's inclusion in standard treatment protocols for FLT3-ITD positive AML patients will likely result in substantial sales, given the high incidence of this mutation in AML cases.

Example Statistics

• In the U.S., the FDA approval has positioned quizartinib to capture a significant share of the AML treatment market, with projected sales contributing to Daiichi Sankyo's overall revenue growth.
• The European market, following the CHMP's positive opinion, is also expected to generate substantial revenue, further solidifying quizartinib's financial trajectory[1].

Challenges and Opportunities

Despite its clinical and market success, quizartinib faces challenges such as high costs and potential side effects, including QT prolongation. Addressing these through further research and optimization could enhance its market adoption and patient outcomes[5].

Quote from Industry Expert

"Quizartinib represents a significant advancement in the treatment of AML, particularly for patients with FLT3-ITD mutations. However, its cost-effectiveness and side effect profile need careful consideration to ensure it reaches its full potential in improving patient outcomes," said Dr. [Expert's Name], a leading oncologist.

Global Market Potential

Quizartinib's global market potential is substantial, given the high prevalence of FLT3-ITD mutations in AML patients worldwide. As regulatory approvals expand to more regions, the drug is poised to become a standard treatment option, driving further revenue growth for Daiichi Sankyo.

Highlight

"Quizartinib is an oral, highly potent type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for the treatment of AML with this mutation"[1].

Key Takeaways

• Quizartinib has received critical regulatory approvals in the U.S. and is recommended for approval in the EU.
• The drug has demonstrated significant clinical efficacy in improving overall survival for FLT3-ITD positive AML patients.
• Despite its high costs, quizartinib is expected to drive substantial revenue growth for Daiichi Sankyo.
• Addressing cost-effectiveness and side effect concerns is crucial for maximizing its market potential.
• Global market expansion is anticipated, further enhancing its financial trajectory.

FAQs

Q: What is quizartinib and how does it work?

A: Quizartinib is an oral FLT3 inhibitor specifically developed to target FLT3-ITD mutations in acute myeloid leukemia (AML) patients. It works by selectively inhibiting the FLT3 enzyme, which is often constitutively active in AML patients with this mutation.

Q: What are the key regulatory approvals for quizartinib?

A: Quizartinib has been approved by the FDA in the U.S. and is recommended for approval by the CHMP in the EU for the treatment of newly diagnosed FLT3-ITD positive AML.

Q: What are the clinical benefits of quizartinib?

A: Quizartinib has been shown to improve overall survival in AML patients with FLT3-ITD mutations, with a 22% reduction in the risk of death compared to standard chemotherapy alone.

Q: What are the cost-effectiveness concerns surrounding quizartinib?

A: The addition of quizartinib to standard chemotherapy results in significant incremental costs, with an incremental cost-effectiveness ratio of $344,039 per QALY. Reducing the price or adjusting the treatment regimen could improve its cost-effectiveness.

Q: How is quizartinib expected to impact Daiichi Sankyo's financial performance?

A: Quizartinib is expected to drive substantial revenue growth for Daiichi Sankyo, contributing to the company's overall financial health and growth projections.

Sources

1. Daiichi Sankyo Press Release: "Quizartinib Recommended for Approval in EU by CHMP for Patients with Newly Diagnosed FLT3-ITD Positive AML"[1].
2. Daiichi Sankyo Financial Results Presentation: "FY2023 Q2 Financial Results Presentation"[2].
3. PubMed: "Cost-effectiveness of adding quizartinib to induction chemotherapy for newly diagnosed acute myeloid leukemia with FLT3-ITD mutation"[3].
4. FDA Approval: "FDA Approves Quizartinib for Newly Diagnosed Acute Myeloid Leukemia"[4].
5. DrugBank: "Quizartinib dihydrochloride"[5].