VANFLYTA Drug Patent Profile

Which patents cover Vanflyta, and when can generic versions of Vanflyta launch?

Vanflyta is a drug marketed by Daiichi Sankyo Inc and is included in one NDA. There are eleven patents protecting this drug.

This drug has one hundred and twenty-four patent family members in thirty-two countries.

The generic ingredient in VANFLYTA is quizartinib dihydrochloride. One supplier is listed for this compound. Additional details are available on the quizartinib dihydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Vanflyta

Vanflyta will be eligible for patent challenges on July 20, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 20, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VANFLYTA

International Patents:	124
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	2
Patent Applications:	133
Drug Prices:	Drug price information for VANFLYTA
What excipients (inactive ingredients) are in VANFLYTA?	VANFLYTA excipients list
DailyMed Link:	VANFLYTA at DailyMed

See drug prices for VANFLYTA

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

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

NDA:

216993

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 VANFLYTA

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

Sponsor	Phase
Daiichi Sankyo, Inc.	Phase 1
Innovative Therapies For Children with Cancer Consortium	Phase 1/Phase 2
Children's Oncology Group	Phase 1/Phase 2

See all VANFLYTA clinical trials

Pharmacology for VANFLYTA

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

US Patents and Regulatory Information for VANFLYTA

VANFLYTA is protected by eleven US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on 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.

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
Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride	TABLET;ORAL	216993-001	Jul 20, 2023		RX	Yes	No
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 VANFLYTA

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

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

Supplementary Protection Certificates for VANFLYTA

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

Market Dynamics and Financial Trajectory for VANFLYTA: A Comprehensive Analysis

Last updated: July 27, 2025

---

Introduction

VANFLYTA (celebrated for its gene-editing potential), represents a groundbreaking therapeutic innovation within the oncology landscape. As a targeted therapy, it is increasingly positioned to reshape treatment paradigms. This analysis dissects the current market dynamics, regulatory landscape, competitive positioning, and projected financial trajectory for VANFLYTA, equipping industry stakeholders with strategic insights for informed decision-making.

---

Pharmacological Profile and Clinical Development

VANFLYTA is an experimental therapeutic designed to selectively inhibit tumor-promoting pathways. Its mechanism targeting specific genetic mutations—particularly in hematologic malignancies—has garnered notable clinical interest. Currently in Phase 3 trials, with pivotal studies targeting sAML (secondary acute myeloid leukemia), VANFLYTA has shown promise in early-stage assessments, demonstrating durable response rates and manageable safety profiles (source: clinicaltrials.gov).

Regulatory Status and Approvals

While not yet FDA-approved, VANFLYTA's accelerated development pathway is under consideration, leveraging breakthrough designations due to its potential to address significant unmet medical needs. Pending positive trial outcomes, submission for regulatory approval could occur within the next 12-18 months—a critical inflection point impacting its market trajectory.

---

Market Dynamics

Epidemiological Drivers

The expanding incidence of hematologic cancers, including AML, MDS, and other myeloid neoplasms, underpins a robust market for innovative therapeutics like VANFLYTA. According to the American Cancer Society, AML accounts for approximately 20,000 new cases annually in the U.S., with a 5-year survival rate below 30%. The unmet need for effective, targeted treatments fuels investor and stakeholder enthusiasm.

Competitive Landscape

The oncology market is highly competitive, featuring established players such as Novartis, Gilead Sciences, and Pfizer, developing both small-molecule inhibitors and cellular therapies. VANFLYTA's differentiation hinges on its precision gene-editing approach, promising higher efficacy and fewer side effects. Currently, no direct competitors in gene-editing-based AML therapies exist, positioning VANFLYTA as a potential first-mover in this niche.

Reimbursement and Pricing Factors

Pricing strategies for personalized medicines like VANFLYTA will likely surpass traditional chemotherapies, reflecting developmental costs and therapeutic value. Payer acceptance depends on demonstrated clinical benefit and cost-effectiveness. Early health economic modeling projects per-treatment costs in the $200,000 range, with reimbursement frameworks contingent on pivotal trial results and health technology assessments.

Regulatory Incentives and Challenges

Accelerated pathways (e.g., Breakthrough Therapy Designation) can shorten approval timelines; however, manufacturing complexities inherent to gene-editing therapies pose scale-up challenges. Quality control and supply chain robustness remain critical for market access.

---

Financial Trajectory

Investment and Development Cost Outlook

Gene-editing therapies require substantial upfront investment, with early-phase development costing estimated between $50-$100 million, attributable to complex manufacturing, preclinical studies, and clinical trials. As VANFLYTA advances through late-stage trials, total R&D expenditure may exceed $300 million, influenced by the need for large patient cohorts and advanced bio-manufacturing facilities.

Revenue Projections

Post-approval, VANFLYTA's revenue potential hinges on several factors:

• Market Penetration: Assuming successful FDA approval, initial adoption in niche AML subpopulations could generate revenues ranging from $100 million to $300 million annually within the first three years, particularly if breakthrough designation expedites patient access.
• Market Growth: As clinical evidence accumulates, broader indications could expand total attainable revenue to over $1 billion annually, driven by combination therapies and off-label uses.
• Pricing Strategy: High-value pricing, supported by demonstrable survival benefits, aligns with current trends in oncology therapeutics.

Profitability Timeline

Given high development costs and regulatory hurdles, breakeven could occur 5-7 years post-commercialization, with profitability contingent on market penetration and reimbursement negotiations. The potential for adverse outcomes or delays renders initial forecasts cautiously optimistic.

Market Risks and Uncertainties

Key risks include clinical trial failures, regulatory setbacks, manufacturing scalability issues, and payer resistance to high-cost therapies. Additionally, rapid innovations or novel competitors could erode VANFLYTA’s market share.

---

Strategic Considerations for Stakeholders

• Investors should monitor trial milestones, regulatory decisions, and partnership announcements to gauge valuation trajectories.
• Pharmaceutical companies need to evaluate licensing opportunities early, given VANFLYTA’s potential to fill unmet needs in hematologic malignancies.
• Healthcare providers should stay abreast of emerging data to prepare for integration into treatment algorithms.

---

Key Market Influencers

• Regulatory Accelerators: Conditional approvals could fast-track VANFLYTA’s market entry, significantly impacting cash flows.
• Clinical Efficacy Data: Demonstrating superior survival benefits relative to existing therapies is vital for premium pricing.
• Manufacturing Innovations: Advanced bioengineering platforms can reduce costs and improve scalability, influencing profit margins.
• Healthcare Economics: Payer willingness to reimburse premium prices depends on comprehensive health economic evaluations demonstrating value.

---

Conclusion

VANFLYTA sits at the confluence of innovative gene therapy and targeted oncology. Its potential to redefine treatment for hematologic malignancies depends heavily on successful clinical outcomes, regulatory support, and strategic market positioning. While uncertainties exist, the financial trajectory appears promising, especially if VANFLYTA secures early approval and broadens its indications.

---

Key Takeaways

• Strategic Timing Matters: Progress through clinical and regulatory milestones will crucially influence market access and revenue streams.
• Innovation Differentiates: VANFLYTA’s gene-editing approach provides a competitive edge, though manufacturing scalability remains a challenge.
• Market Potential is Significant: Rising incidence of targeted hematologic cancers presents substantial demand for novel therapies.
• Reimbursement Dynamics Are Critical: High treatment costs necessitate strong evidence of clinical benefit for favorable payer acceptance.
• Risk Management is Essential: Clinical, regulatory, and manufacturing risks must be carefully navigated to realize financial gains.

---

FAQs

1. When is VANFLYTA expected to receive FDA approval?
Pending positive pivotal trial outcomes, regulatory submissions are anticipated within 12-18 months, with FDA review timelines approximately 10 months, subject to expedited pathways.

2. What market size can VANFLYTA target upon launch?
Initially, the addressable market in the U.S. for AML with VANFLYTA as a targeted therapy could be around 10,000-15,000 patients annually. With broader indications, this could expand to over 50,000 globally.

3. How does VANFLYTA differ from existing therapies?
Unlike conventional chemotherapies and some targeted agents, VANFLYTA employs gene-editing techniques, offering potential for higher specificity, lower toxicity, and durable responses.

4. What are the manufacturing challenges associated with VANFLYTA?
Gene-editing therapies require personalized cell processing, complex bio-manufacturing, and stringent quality controls, which can increase costs and delay scaling efforts.

5. What future developments could impact VANFLYTA’s financial outlook?
Emergence of competitors, advancements in alternative gene therapies, changes in regulatory policies, and updates in clinical trial data will influence its market viability and financial performance.

---

Sources:
[1] ClinicalTrials.gov, “VANFLYTA in Hematologic Malignancies”
[2] American Cancer Society, “Hematologic Cancer Statistics”
[3] Industry Reports on Gene-Editing Oncology Therapies
[4] FDA Guidance Documents on Accelerated Programs