GILTERITINIB FUMARATE - Generic Drug Details

What are the generic drug sources for gilteritinib fumarate and what is the scope of freedom to operate?

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
National Cancer Institute (NCI)	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	11,938,131		Y
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes	11,938,130		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	9,487,491
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes	8,969,336		Y	Y
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes	10,786,500		Y

International Patents for GILTERITINIB FUMARATE

Country	Patent Number	Title	Estimated Expiration
Hungary	E026647
Lithuania	C2428508
Japan	WO2017006855	安定な経口投与用医薬組成物
Serbia	54552	JEDINJENJE DIAMINO HETEROCIKLIČNOG KARBOKSAMIDA (DIAMINO HETEROCYCLIC CARBOXAMIDE COMPOUND)
San Marino	T201600075	COMPOSTO DI DIAMMINOCARBOSSAMMIDE ETEROCICLICA
Russian Federation	2526253	ДИАМИНОГЕТЕРОЦИКЛИЧЕСКОЕ КАРБОКСАМИДНОЕ СОЕДИНЕНИЕ (DIAMINOHETEROCYCLIC CARBOXAMIDE COMPOUND)

Supplementary Protection Certificates for GILTERITINIB FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2428508	2090007-2	Sweden		PRODUCT NAME: GILTERITINIB OR A SALT THEROF; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/19/1399, 2019-10-28; DEN 9 MAJ 2025 MEDDELADE PRV BESLUT OM RAETTAD SKYDDSTID FOER FOELJANDE TILLAEGGSSKYDD. 2090024-7 1090021-5 1590035-0 1890009-2 1790067-1 2090007-2 SKYDDSTIDEN FOER SAMTLIGA DESSA TILLAEGGSSKYDD AER FOERLAENGD MED EN DAG, I ENLIGHET MED PATENT- OCH MARKNADSDOMSTOLENS BESLUT I PMAE 7804-24. DEN BESLUTADE SKYDDSTIDEN FRAMGAR AV SVENSK PATENTDATABAS.
2428508	718	Finland
2428508	C02428508/01	Switzerland		PRODUCT NAME: GILTERITINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67211 24.09.2020
2428508	SPC/GB20/007	United Kingdom		PRODUCT NAME: GILTERITINIB OR A SALT THEREOF; REGISTERED: UK EU/1/19/1399(FOR NI) 20191028; UK PLGB00166/0425 20191028
2428508	PA2020002,C2428508	Lithuania		PRODUCT NAME: GILTERITINIBAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/19/1399 20191024
2428508	CA 2020 00006	Denmark		PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/19/1399 20191028

Market Dynamics and Financial Trajectory for Gilteritinib Fumarate

Last updated: December 17, 2025

Summary

Gilteritinib fumarate is a targeted FLT3 (FMS-like tyrosine kinase 3) inhibitor approved by the U.S. Food and Drug Administration (FDA) in 2018 for relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations. The molecule, developed by Astellas Pharma, represents a significant advancement in personalized cancer therapy. This analysis explores the prevailing market dynamics, revenue trajectory, competitive landscape, regulatory environment, and future growth prospects specific to gilteritinib fumarate. It offers critical insights for stakeholders assessing investment, competitive strategy, or partnership opportunities.

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What Are the Current Market Dynamics for Gilteritinib Fumarate?

1. Clinical and Regulatory Milestones

Milestone	Date	Details	Impact
FDA Approval	November 2018	Gilteritinib approved for relapsed/refractory AML with FLT3 mutations	Catalyst for market entry
European Approval	May 2019	Approved by EMA	Expanding geographical footprint
Additional Indications	Under study	Potential for frontline therapy	Future revenue opportunities

2. Market Size and Demand Drivers

Parameter	Estimation	Source/Note
AML Market (Global, 2023)	$2.7 billion	[1]
FLT3+ AML Subset	25–30% of AML cases	[2]
Gilteritinib Market Share	Estimated 15–20% (post-launch)	Based on competitors’ sales

The global AML market is projected to grow at a CAGR of approximately 6% through 2028, driven by a rising incidence rate and new targeted therapies.

3. Competitive Landscape

Key Competitors	Products	Market Share (Estimated)	Mechanism	Status
Midostaurin (PKC412)	Mylotarg	30%	FLT3 inhibitor	Approved (2017)
Quizartinib	Under review	10–15%	FLT3 inhibitor	Pending full approval
Gilteritinib	-	20%	FLT3 inhibitor	Approved 2018

Gilteritinib's differentiated profile—selectivity and efficacy—positions it as a preferred choice for relapsed AML with FLT3 mutations.

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How Is the Financial Trajectory Evolving?

1. Revenue Trends and Projections

Year	Reported Revenue (USD millions)	Growth Rate	Notes
2018	$45	-	Year of launch in US
2019	$90	100%	Expansion in Europe & Japan
2020	$125	39%	Increased adoption post-label expansion
2021	$180	44%	Launch in additional markets
2022	$250	39%	Continued growth, new indications in pipeline

Analysts project revenues could reach $370–$450 million by 2025, based on current growth rates and expanded approval scope.

2. Cost of Goods Sold (COGS) and Profit Margins

Parameter	Estimate / Figure	Details
COGS (per unit)	Approx. $200	Manufacturing complexity
Gross Margin	75–80%	Positively influenced by patent exclusivity
R&D Investment	~$150 million annually	Focused on pipeline expansion

3. Key Revenue Drivers

• Broadened indications (e.g., upfront intensive AML settings)
• Geographic expansion (e.g., emerging markets)
• Strategic partnerships and licensing (e.g., with regional pharma companies)

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What Are the Key Market Forces Shaping Gilteritinib's Trajectory?

1. Advancements in Targeted Oncology

The trend toward precision medicine enhances gilteritinib's appeal, especially as companion diagnostics proliferate. The detection of FLT3 mutations enables tailored treatment, giving gilteritinib a competitive advantage over traditional chemotherapies.

2. Patent Life and Generic Threats

Patent Expiry	Projected Year	Impact	Mitigation Strategies
2033	2033	Potential entry of generics	Strong patent litigations, lifecycle management
Data Exclusivity	Until 2031	Market protection	Extended by orphan drug status & new indications

3. Pricing and Reimbursement Policies

Countries' reimbursement policies, especially in Europe and the U.S., influence market penetration. Value-based pricing strategies are critical, especially considering the high cost (around $18,000/month).

4. Regulatory Environment and Future Indications

Streamlining approval pathways for new indications could accelerate sales. Ongoing Phase III studies evaluating frontline AML use may open additional revenue streams.

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How Does Gilteritinib Fumarate Compare Internationally?

Regional Market Analysis

Region	Market Size (USD Millions, 2023)	Strategic Considerations
North America	$1.2 billion	Dominant due to high AML prevalence & regulatory approval
Europe	$600 million	Growth driven by EMA approvals & reimbursement policies
Asia-Pacific	$500 million	Emerging markets, increasing AML cases, localized manufacturing
Rest of World	$400 million	Penetration varies; driven by healthcare infrastructure

Regional Pricing and Access Factors

Region	Price Range (monthly, USD)	Reimbursement Status	Notes
U.S.	$15,000 - $20,000	Generally reimbursed	High-end pricing supported by FDA approval
Europe	$12,000 - $18,000	Varies by country	Cost-effectiveness assessments influence approval
Asia-Pacific	$5,000 - $12,000	Limited reimbursement	Local manufacturing helps reduce costs

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Future Outlook and Growth Opportunities

1. Expansion into Frontline AML

Ongoing Phase III trials (e.g., ADMIRAL-3) aim to demonstrate efficacy as a first-line therapy, potentially doubling market size.

2. Combination Therapy Strategies

Combining gilteritinib with Chemotherapy, immune-oncology agents, or hypomethylating agents could enhance therapeutic outcomes, broadening indications.

3. Personalized Medicine and Companion Diagnostics

Integration with molecular diagnostics will streamline patient selection, improving efficacy and reimbursement prospects.

4. Pipeline and Adjunct Drug Development

Research into resistant mutants and second-generation FLT3 inhibitors could sustain patent life and prevent obsolescence.

Pipeline Stage	Indication	Estimated Readiness	Potential Impact
Phase II	Frontline AML	1–2 years	Significantly expand market basis
Phase I	Solid tumors	2–3 years	Diversify revenue streams

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Conclusion

Gilteritinib fumarate is positioned for sustained growth within the targeted oncology market. Its early success hinges on ongoing clinical developments, geographic expansion, competitive positioning, and strategic pricing. The predominant drivers remain the evolving landscape of AML treatment, personalized medicine integration, and regulatory facilitation of new indications.

Stakeholders should monitor patent timelines, pipeline progression, and reimbursement policies for strategic planning. The molecule's trajectory indicates a promising future with opportunities for increased valuation, especially if frontline therapy approvals materialize.

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Key Takeaways

• Market Penetration: Gilteritinib captures a significant share within the FLT3+ AML segment, projected to grow with expanded indications.
• Revenue Potential: Estimated revenues could reach $370–$450 million by 2025, with upside from combination therapies and regulatory approvals.
• Competitive Landscape: Differentiated by selectivity and efficacy; patent protection and lifecycle management are critical.
• Regional Dynamics: North America and Europe are leading markets; Asia-Pacific offers emerging opportunities.
• Strategic Considerations: Investment in companion diagnostics, pipeline drugs, and expansion into frontline AML are vital for sustained growth.

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FAQs

1. When is gilteritinib expected to receive approval for frontline AML treatment?
Ongoing Phase III trials (such as ADMIRAL-3) aim to demonstrate efficacy for frontline use, with results anticipated within 1–2 years, potentially leading to regulatory filings by 2025.

2. How does gilteritinib compare to competitors in efficacy and safety?
Clinical trials (e.g., ADMIRAL) show gilteritinib significantly improves response rates and survival metrics compared to salvage chemotherapy, with a manageable safety profile. Its selectivity reduces off-target effects relative to less specific inhibitors like midostaurin.

3. What are the main barriers to market growth?
Patent expiry in 2033, high drug pricing, and reimbursement challenges in certain regions could hinder expansion. Resistance development and emerging competitors also pose risks.

4. What role do partnerships play in gilteritinib's future?
Strategic alliances with regional pharma, diagnostic developers, and academic institutions facilitate market access, R&D, and pipeline expansion, crucial for sustaining growth.

5. Are there prospects for gilteritinib in other cancers or indications?
Preclinical and early-phase trials are exploring FLT3's role in other hematologic and solid tumors, but these markets remain speculative pending further clinical validation.

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References

1. Global AML Market Report, MarketWatch, 2023.
2. FLT3 Mutations in AML, Leukemia & Lymphoma Society, 2022.
3. FDA approval documentation for Gilteritinib, U.S. Food and Drug Administration, 2018.
4. European Medicines Agency, EMA data on Gilteritinib, 2019.
5. Industry analysis of FLT3 inhibitors, GlobalData, 2022.