Gilteritinib fumarate - Generic Drug Details

What are the generic sources for gilteritinib fumarate and what is the scope of patent protection?

Gilteritinib fumarate is the generic ingredient in one branded drug marketed by Astellas and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Gilteritinib fumarate has eighty patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for gilteritinib fumarate

International Patents:	80
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	3
Patent Applications:	603
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for gilteritinib fumarate
DailyMed Link:	gilteritinib fumarate at DailyMed

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

Constraining patent/regulatory exclusivity:

10,786,500

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 gilteritinib fumarate

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

Sponsor	Phase
City of Hope Medical Center	Phase 1
National Cancer Institute (NCI)	Phase 1
Children's Oncology Group	Phase 3

See all gilteritinib fumarate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for gilteritinib fumarate

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

Paragraph IV (Patent) Challenges for GILTERITINIB FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XOSPATA	Tablets	gilteritinib fumarate	40 mg	211349	1	2022-11-28

US Patents and Regulatory Information for gilteritinib fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes	11,938,132		Y
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes	9,487,491
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes	11,938,131		Y
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes	11,944,620		Y
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes	10,786,500		Y
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes	8,969,336		Y	Y

International Patents for gilteritinib fumarate

Country	Patent Number	Title	Estimated Expiration
Mexico	378947	COMPOSICIÓN FARMACÉUTICA ESTABLE PARA ADMINISTRACIÓN ORAL. (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINSITRATION)
France	20C1003
Croatia	P20230253
South Korea	20180023914	안정된 경구 투여용 의약 조성물
South Korea	20120007523	DIAMINO HETEROCYCLIC CARBOXAMIDE COMPOUND
Hungary	E038515

Supplementary Protection Certificates for gilteritinib fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2428508	PA2020002,C2428508	Lithuania		PRODUCT NAME: GILTERITINIBAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/19/1399 20191024
2428508	C02428508/01	Switzerland		PRODUCT NAME: GILTERITINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67211 24.09.2020
2428508	C202030004	Spain		PRODUCT NAME: GILTERITINIB O UNA SAL DEL MISMO NOMBRE; NATIONAL AUTHORISATION NUMBER: EU/1/19/1399; DATE OF AUTHORISATION: 20191024; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1399; DATE OF FIRST AUTHORISATION IN EEA: 20191024
2428508	132020000000016	Italy		PRODUCT NAME: GILTERITINIB E SUOI SALI(XOSPATA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1399, 20191028
2428508	301028	Netherlands		PRODUCT NAME: GILTERITINIB OF EEN ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/19/13177 20191028
2428508	718	Finland

Market Dynamics and Financial Trajectory for Gilteritinib Fumarate

Last updated: July 28, 2025

Introduction

Gilteritinib fumarate represents a targeted therapy within the hematology-oncology sector, primarily approved for treating relapsed or refractory acute myeloid leukemia (AML) harboring FLT3 mutations. Since its FDA approval in 2018, the drug’s market performance has been influenced by evolving clinical data, competitive landscape, regulatory developments, and broader oncology trends. This analysis explores the key market dynamics and the potential financial trajectory of gilteritinib fumarate, providing insights for stakeholders evaluating growth prospects and investment opportunities.

Pharmacological Profile and Clinical Positioning

Gilteritinib fumarate (brand name: Xospata®) is a potent, selective FLT3 inhibitor developed by Astellas Pharma. Its mechanism targets FLT3 mutations, which are present in approximately 30% of AML cases, marking it as a cornerstone in precision hematology. The drug’s efficacy, demonstrated in the ADMIRAL trial, positioned it as a significant therapeutic advancement for a high unmet need population [1].

The approval of gilteritinib filled a clinical gap, offering a targeted oral therapy after initial induction, and gained rapid adoption in relapsed/refractory settings. Its ability to improve overall survival (OS) compared to salvage chemotherapy contributed to early positive market momentum.

Market Size and Demand Drivers

The AML treatment market is projected to surpass USD 2 billion by 2025, driven by increasing incidence, better diagnostic stratification, and a trend toward targeted therapies [2]. Gilteritinib’s addressable patient population is approximately 7,000-8,000 cases annually in the U.S. alone, considering relapse/refractory patients with FLT3 mutations. Globally, this expands to over 15,000 patients, factoring in higher prevalence rates in regions like Asia.

Demand is further propelled by:

• Enhanced clinical data confirming survival benefits.
• Expanding indications: Ongoing trials investigating gilteritinib as part of combination regimens or frontline therapy could broaden its usage.
• Physician acceptance, reinforced by guideline endorsements such as NCCN and ASH.

Competitive Landscape

Gilteritinib faces competition primarily from other FLT3 inhibitors:

• Midostaurin (Rydapt®): Approved for frontline AML with FLT3 mutations, with broader application but less selective [3].
• Quizartinib: Under clinical evaluation, with some approvals outside the U.S., though regulatory hurdles persist [4].
• Crenolanib: Investigated mainly in relapsed settings, with promising activity against FLT3 mutations.

The competitive positioning of gilteritinib hinges on:

• Superior efficacy and safety profile.
• Oral administration convenience.
• Regulatory support and label extensions.

Emerging therapies, including combinations with BCL-2 inhibitors or hypomethylating agents, threaten to dilute its market share over time.

Regulatory and Reimbursement Environment

Post-approval, Gilteritinib encountered positive reimbursement pathways in the U.S. and Europe, supported by health technology assessments emphasizing its clinical benefit. However, access varies across regions, with pricing negotiations affecting downstream revenues.

The pharmacoeconomic landscape emphasizes the importance of cost-effectiveness, especially considering the high treatment costs of AML therapies. The drug’s pricing strategy, with an initial list price around USD 30,000–USD 50,000 per treatment course, positions it as a premium therapy aligned with its targeted approach.

Market Penetration and Growth Strategies

Astellas’ commercialization efforts focus on:

• Expanding geographic reach through licensing agreements and local collaborations, notably in Asia.
• Educational campaigns to promote guideline-driven use.
• Investing in clinical trials to solidify its position in combination and frontline settings.

Further, the integration into minimal residual disease (MRD) monitoring and personalized treatment algorithms could prolong its adoption cycle.

Financial Trajectory and Forecast

The initial peak sales of gilteritinib ราคา were approximately USD 200–300 million in 2020–2021, reflecting rapid uptake post-launch. Analyst projections suggest a compound annual growth rate (CAGR) of 10–15% over the next five years, contingent on several factors:

• Indication expansion: Successful phase 3 trials involving gilteritinib as first-line therapy or in combination regimens could significantly amplify revenues, potentially doubling sales figures.
• Market penetration: Increased adoption in Europe, Asia, and Latin America will diversify revenue streams.
• Patent horizon and lifecycle management: Patent expiry around 2035 necessitates lifecycle strategies—such as line extensions or new formulations—to sustain revenues.

Potential headwinds include:

• Pricing pressures driven by healthcare payers.
• Emerging competitors possibly offering enhanced efficacy or reduced costs.
• Regulatory delays or adverse clinical trial outcomes.

In light of these factors, Astellas might project cumulative global sales reaching USD 1.2–1.5 billion by 2030, assuming successful indication expansions and steady market penetration.

Market Risks and Opportunities

Key risks entail:

• Regulatory setbacks or adverse safety signals.
• Delayed or failed clinical trials for combination or frontline indications.
• Market saturation if competitors introduce next-generation FLT3 inhibitors.

Conversely, opportunities exist through:

• Combination therapy approvals, expanding indications.
• Biomarker-driven patient stratification, increasing treatment efficiency.
• Strategic collaborations to accelerate global reach.

Conclusion

Gilteritinib fumarate exhibits a resilient market profile anchored in its targeted mechanism, proven efficacy, and unmet need in relapsed/refractory AML. Its financial trajectory depends heavily on clinical development success, competitive dynamics, and strategic commercialization efforts. As the AML landscape evolves towards personalized oncology, gilteritinib’s role could expand, supporting steady or heightened revenue growth.

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Key Takeaways

• Gilteritinib fumarate currently commands a significant share in the relapsed/refractory AML market with projected steady growth driven by clinical validation and regulatory support.
• Future revenue streams hinge on the drug’s potential expansion into frontline therapy and combination regimens.
• Competitive pressures, clinical trial outcomes, and pricing strategies will influence its long-term financial outlook.
• Strategic investments in indication advancement and international expansion are critical for maximizing its market potential.
• Stakeholders should monitor emerging therapies and evolving treatment guidelines to assess competitive threats and opportunities.

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FAQs

1. What are the primary factors influencing gilteritinib fumarate’s market growth?
The drug’s market growth is driven by its efficacy in FLT3-mutated AML, clinical trial success, regulatory approvals, expanding indications, physician acceptance, and regional market expansion.

2. How does gilteritinib compare to other FLT3 inhibitors?
Gilteritinib demonstrates high selectivity and potency, with a proven survival benefit in relapsed/refractory AML. Competing agents like midostaurin are less selective but approved for broader indications, making gilteritinib more suitable for targeted therapy.

3. What are the main barriers to gilteritinib’s market penetration?
Key barriers include competition from emerging therapies, pricing and reimbursement challenges, clinical trial outcome uncertainties, and regional regulatory differences.

4. What is the forecasted revenue trajectory for gilteritinib?
Projections suggest a CAGR of 10–15% over five years, with potential sales reaching USD 1.2–1.5 billion globally by 2030, assuming successful indication expansion and market penetration.

5. What strategic moves can maximize gilteritinib’s market potential?
Advancing clinical research, securing approval for additional indications, expanding geographical access, and establishing strategic collaborations are pivotal strategies for maximizing revenue.

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References

[1] Perl, A.E., et al. (2019). Gilteritinib or chemotherapy for relapsed or refractory FLT3-mutated AML. New England Journal of Medicine, 381(18), 1728-1740.
[2] MarketsandMarkets. (2022). Hematology Oncology Drugs Market.
[3] Döhner, H., et al. (2017). Diagnosis and management of AML in adults: 2017 ELN recommendations. Blood, 129(4), 424-447.
[4] Stirewalt, D.L., et al. (2020). Quizartinib in AML: Current status and future perspectives. Leukemia & Lymphoma, 61(11), 2595–2602.