XOSPATA Drug Patent Profile

Which patents cover Xospata, and what generic alternatives are available?

Xospata is a drug marketed by Astellas and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has eighty patent family members in thirty-one countries.

The generic ingredient in XOSPATA is gilteritinib fumarate. One supplier is listed for this compound. Additional details are available on the gilteritinib fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Xospata

Xospata was eligible for patent challenges on November 28, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 1, 2036. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for XOSPATA

International Patents:	80
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	10
Patent Applications:	314
Drug Prices:	Drug price information for XOSPATA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XOSPATA
What excipients (inactive ingredients) are in XOSPATA?	XOSPATA excipients list
DailyMed Link:	XOSPATA at DailyMed

See drug prices for XOSPATA

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

Constraining patent/regulatory exclusivity:

11,938,130

NDA:

211349

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 XOSPATA

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

Sponsor	Phase
Kura Oncology, Inc.	Phase 1
French Innovative Leukemia Organisation	Phase 2
Acute Leukemia French Association	Phase 2

See all XOSPATA clinical trials

Paragraph IV (Patent) Challenges for XOSPATA

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 XOSPATA

XOSPATA is protected by eight US patents.

This potential generic entry date is based on patent 11,938,130.

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
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	11,938,130		Y
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	11,938,133		Y

International Patents for XOSPATA

When does loss-of-exclusivity occur for XOSPATA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

China

Croatia

Denmark

European Patent Office

Finland

Hong Kong

Hungary

Japan

Lithuania

Mexico

Philippines

Poland

Portugal

Russian Federation

San Marino

Serbia

Slovenia

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XOSPATA around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1117546
European Patent Office	2428508
China	107847500
Taiwan	I484961
Mexico	2011011875	COMPUESTO DE CARBOXAMIDA HETEROCICLICA DIAMINO. (DIAMINO HETEROCYCLIC CARBOXAMIDE COMPOUND.)

Supplementary Protection Certificates for XOSPATA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2428508	PA2020002	Lithuania		PRODUCT NAME: GILTERITINIBAS; 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
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	301028	Netherlands		PRODUCT NAME: GILTERITINIB OF EEN ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/19/13177 20191028
2428508	2020/004	Ireland		PRODUCT NAME: GILTERITINIB OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/19/1399 20191024

XOSPATA (gilteritinib) Market Dynamics and Financial Trajectory

Last updated: April 22, 2026

XOSPATA (gilteritinib) is a targeted oral therapy for relapsed or refractory acute myeloid leukemia (R/R AML) with a FLT3 mutation. Commercial momentum has been shaped by (1) label breadth tied to FLT3 status, (2) competitive entry from FLT3 and broader AML targeted regimens, (3) payer scrutiny and net price pressure typical for oncology in the US, and (4) uptake sensitivity to line of therapy and biomarker testing infrastructure. Financial trajectory is best evaluated through annual net product revenue trends, segment disclosures for Astellas, and net sales lifecycle metrics including branded oncology share and gross-to-net compression.

What is the approved market and how does label scope drive demand?

Indication scope (core commercialization unit)

XOSPATA is approved for:

• Relapsed or refractory AML with an FLT3 mutation, in patients who have received prior therapy (US label context).
• FLT3-mutated, relapsed or refractory AML has been a central anchor for prescribing and reimbursement strategy, with demand tied to biomarker prevalence in AML and access to FLT3 testing workflows.
• Line-of-therapy positioning: real-world uptake is concentrated where clinicians choose FLT3 inhibition after failure of prior regimens or in settings where FLT3 inhibition provides the most defensible benefit-risk profile.

Source: FDA label and indication statements for XOSPATA (gilteritinib). [1]

Biomarker testing and treatment selection dynamics

XOSPATA demand depends on:

• FLT3 mutation prevalence in R/R AML screening pools.
• Time-to-test and turnaround for molecular diagnostics, which can determine whether patients start on schedule or miss a treatment window.
• Second-line and beyond behavior: uptake typically strengthens where guidelines and institutional pathways support FLT3 targeted therapy after prior exposure.

Source: FDA label. [1]

How is XOSPATA positioned versus FLT3 and AML competitors?

Competitive set framing

Commercial rivalry centers on:

• FLT3 inhibitors (same biomarker target class).
• Emerging AML targeted regimens that compete for attention and sequencing in R/R AML.

Key competitive variables that influence market share transfer:

• Depth and durability of response by FLT3 subgroup and prior HMA exposure.
• Tolerability that affects adherence and dose continuity.
• Evidence perceived by payers and institutions for use after different treatment histories.
• Formulary adoption and prior authorization requirements, especially where competitors offer preferred-tier status.

Source: FDA label supports indication and clinical use context for XOSPATA. [1]

Practical market dynamics

In oncology branded products, share is typically driven more by:

• Network-level prescribing (site of care and hematology/oncology group adoption),
• Pathway placement (what lines of therapy get FLT3-inhibitor selection),
• Net pricing and contracting (discounting to PBM and GPO clients), than by headline efficacy alone.

What financial trajectory does XOSPATA show and what drives it?

What to track for financial trajectory

For a branded oncology drug like XOSPATA, the cleanest financial lenses are:

• Net product revenue (not gross).
• Gross-to-net dynamics (rebates, discounts, chargebacks).
• International contribution if the company reports ex-US performance.
• Segment operating leverage in company reporting, where branded oncology can offset pipeline spend.

Astellas’ reporting typically breaks out drug sales by major marketed products inside its segment disclosures.

Revenue lifecycle logic specific to XOSPATA

XOSPATA’s financial trajectory is most sensitive to:

1. Uptake ramp and persistence
   Higher persistence in responders supports revenue durability, while discontinuations shrink near-term demand.
2. Competitive displacement and sequencing changes
   Even without label cuts, new standard-of-care choices can reduce incremental starts.
3. Net price pressure
   Oncology in the US sees ongoing contracting pressure, especially once competitors establish stable market share.
4. Health system behavior after guideline updates
   Guideline-driven prescribing patterns alter line-of-therapy starting points.

Investment-style interpretation of trajectory drivers

• Bull case: sustained share in FLT3-mutated R/R AML plus broader adoption within the FLT3 testing funnel.
• Bear case: accelerated competitive displacement plus persistent net price compression.

How do payer dynamics influence net sales growth and margin profile?

US payer mechanics that typically hit branded oncology

XOSPATA’s gross-to-net and net price are influenced by:

• Manufacturer rebates and discounts to PBMs and plans.
• Contracting terms with integrated delivery networks and large group purchasing organizations.
• Prior authorization and utilization management that can slow initiation and reduce new starts.

Clinical administration and adherence impact

As an oral targeted therapy, revenue depends on:

• Adherence and treatment persistence (tied to tolerability and adverse event management).
• Dose interruption patterns that affect the duration of paid therapy per patient.

What is the commercialization outlook: where does demand likely expand or contract?

Demand expansion levers

• Broader institutional comfort with oral FLT3 inhibition.
• Earlier adoption if treatment pathways support FLT3 targeted therapy at more lines.
• Increased FLT3 testing coverage at community sites, raising the addressable pool.

Demand contraction levers

• Competitive preference for alternative FLT3 inhibitors or combination regimens.
• Shifts in sequencing away from monotherapy FLT3 inhibition toward other targeted strategies.
• More aggressive pricing pressure as market share matures.

Source: FDA label anchors the clinical-use framework for R/R FLT3-mutated AML. [1]

Key takeaways

• XOSPATA demand is structurally driven by FLT3-mutated R/R AML and the ability of clinicians and health systems to test, authorize, and initiate FLT3-targeted therapy.
• Market share is influenced by competition within FLT3 inhibition and by line-of-therapy sequencing, not only by clinical headline outcomes.
• Financial trajectory should be assessed through Astellas net product revenue trends and gross-to-net pressure typical of branded oncology as market maturity increases.
• Near-term upside or downside is most likely to come from net pricing, treatment persistence, and incremental starts within the FLT3 testing funnel.

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FAQs

1) What is XOSPATA’s main commercial indication?

XOSPATA is approved for relapsed or refractory AML with an FLT3 mutation, in a prior-treatment context. [1]

2) What drives XOSPATA adoption in hospitals and clinics?

Adoption is primarily driven by FLT3 biomarker identification, line-of-therapy placement, and payer access (coverage, prior authorization, and formulary status). [1]

3) What competitive threats are most relevant to XOSPATA?

Competition is most directly from FLT3 inhibitors and from broader AML targeted regimens that compete for patients in R/R settings. [1]

4) How does payer pressure show up in branded oncology financials?

It typically shows up as gross-to-net compression via rebates, discounts, and utilization management that reduces net price and can slow initiation. [1]

5) What is the best way to benchmark XOSPATA’s financial trajectory?

Use net product revenue trends and disclosed company segment performance, then link changes to new starts, persistence, and net price dynamics.

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References

[1] U.S. Food and Drug Administration. XOSPATA (gilteritinib) prescribing information. FDA label.

DrugChatter Q&A for XOSPATA

How does Xospata treat AML?