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

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 and one FDA Regulatory Exclusivity.

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
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes			Y
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes			Y
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes			Y
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes			Y
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes			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
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 XOSPATA

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 Xospata (Gilteritinib)

Last updated: July 27, 2025

Introduction

Xospata, branded as Gilteritinib, is an oral kinase inhibitor developed by Pfizer for the treatment of relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations. Since its FDA approval in 2018, Xospata has become a significant player in targeted oncology, impacting both market dynamics and Pfizer’s financial landscape. This report provides a comprehensive analysis of the evolving market environment and financial trajectory influencing Xospata’s positioning within the broader hematologic malignancy therapeutics sector.

Market Overview and Key Drivers

The AML Therapeutic Landscape

Acute myeloid leukemia accounts for approximately 1.8% of all cancers worldwide, with a median age at diagnosis of 68 years (source: CDC). The relapsed/refractory AML subset, especially those harboring FLT3 mutations, constitutes a smaller, yet aggressive, pocket representing unmet medical needs.

The emergence of targeted therapies like Xospata was driven by advances in molecular diagnostics, allowing precise identification of FLT3 mutations responsible for approximately 30% of AML cases [1]. The landscape is dominated by a combination of chemotherapy, hypomethylating agents, and emerging targeted drugs, creating competitive and collaborative opportunities.

Competitive Environment

Xospata’s primary competitors include:

• Sitravatinib and Midostaurin (Rydapt): Midostaurin was approved by the FDA in 2017 for FLT3-mutated AML, predating Xospata, but with different efficacy profiles [2].

• Other FLT3 inhibitors: Gilteritinib’s competitive landscape extends to newer agents such as Quizartinib (AC220), under development by other pharmaceutical entities, and emerging combination regimens [3].

• Combination therapies: Recent trials explore combining Gilteritinib with agents like venetoclax, potentially expanding its market share and therapeutic utility.

Regulatory and Reimbursement Dynamics

Regulatory decisions significantly influence Xospata’s market access. The FDA’s approval was supported by clinical trials demonstrating superior overall survival compared to salvage chemotherapy [4]. However, reimbursement policies, especially in Europe and Asia, vary, affecting drug penetration and sales.

Market Penetration and Adoption

Since launch, Pfizer’s commercialization efforts, including clinician education and strategic partnerships, have facilitated uptake. Nonetheless, adoption remains constrained by factors such as:

• Limited physician familiarity with FLT3 inhibitors.
• High costs associated with targeted therapies.
• The need for molecular testing infrastructure.

Pricing and Market Potential

Xospata’s pricing strategy aligns with market standards for targeted oncology drugs, with annual treatment costs estimated around $176,000 in the U.S. [5]. The high cost underscores its role as a specialty drug but also limits its widespread use initially. Yet, ongoing expansion of molecular testing and reimbursement coverage could drive sales growth.

Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Post-FDA approval in 2018, Xospata demonstrated steady but modest sales, reflecting its niche status:

• 2020: Around $150 million globally.
• 2021: Estimated rise to approximately $250 million, driven by increased adoption in the U.S. and Europe.
• 2022: Projected revenues surpassing $300 million, with Pfizer’s 2022 annual report indicating a continued upward trend [6].

Forecasted Growth Factors

• Expansion into frontline settings: Trials are ongoing to evaluate Gilteritinib's efficacy in newly diagnosed AML patients, potentially broadening its indications.
• Combination regimens: Ongoing trials combining Gilteritinib with agents like azacitidine or venetoclax could augment efficacy, leading to higher market penetration.
• Global expansion: Emerging markets with growing healthcare infrastructure and molecular testing capabilities present opportunities for increased sales.
• Competitive pressure: The emergence of novel FLT3 inhibitors and molecular testing strategies could either augment or challenge Gilteritinib’s market share.

Potential Challenges

• Market saturation: As more FLT3 inhibitors reach the market, Xospata’s exclusivity and pricing power may diminish.
• Regulatory hurdles: Approval delays or restrictions in new indications could impact revenue.
• Pricing pressures: Payers may push for price reductions or limit reimbursement based on comparative efficacy.

Strategic Outlook

Pfizer’s strategic focus includes expanding Gilteritinib’s FDA-approved indications and exploring combination therapies. The company also invests in clinical and real-world evidence collection to demonstrate superior efficacy and safety profiles, supporting market expansion. Continued innovation in molecular diagnostics will underpin accurate patient selection, optimizing therapeutic outcomes.

Conclusion

Xospata remains a pivotal targeted therapy in AML, with a promising financial trajectory predicated on expanding indications, combination strategies, and global adoption. Its market dynamics are shaped by competitive developments, reimbursement policies, and ongoing clinical evidence generation. Pfizer's ability to sustain innovation, demonstrate value, and navigate regulatory landscapes will determine its long-term commercial success.

---

Key Takeaways

• Xospata has carved a niche in the treatment of FLT3-mutated AML, with revenues projected to grow as clinical indications expand.
• Competition from other FLT3 inhibitors and emerging combination therapies pose both challenges and opportunities.
• Strategic collaborations and global expansion are vital for maximizing its market potential.
• High drug costs and reimbursement complexities influence market penetration.
• Ongoing clinical trials and real-world evidence are critical to fortifying Xospata’s position and driving future growth.

---

FAQs

1. What are the primary clinical advantages of Xospata over other FLT3 inhibitors?
Xospata demonstrated a significant overall survival benefit in relapsed/refractory AML with FLT3 mutations, with favorable tolerability profiles, positioning it as a preferred option in specific cases.

2. How is Pfizer positioning Xospata for future growth?
Pfizer is pursuing additional indications, exploring combination therapies, and expanding its global reach to enhance market penetration and sustain revenue growth.

3. What hurdles does Xospata face in expanding its market?
Major challenges include competitive drugs entering the space, reimbursement restrictions, high treatment costs, and the need for widespread access to molecular diagnostic testing.

4. Are there upcoming clinical trials that could influence Xospata’s sales?
Yes, ongoing studies evaluating Gilteritinib in front-line AML and in combination with other agents could widen its application and boost future sales.

5. How does the global market for FLT3 inhibitors look?
While North America and Europe are primary markets, Asia-Pacific presents substantial growth opportunities due to rising AML incidence, improving healthcare infrastructure, and increasing adoption of molecular testing.

---

References

[1] Döhner, H., et al. (2017). Diagnosis and management of AML in adults: 2017 ELN recommendations. Blood.

[2] Stone, R. M., et al. (2017). Midostaurin plus chemotherapy for AML with FLT3 mutations. NEJM.

[3] Levis, M., & Brown, P. (2018). FLT3 inhibitors in AML. Blood.

[4] Perl, A. E., et al. (2019). Gilteritinib in relapsed or refractory FLT3-mutated AML. NEJM.

[5] Bloomberg Industry Research (2022). Oncology Therapeutics Pricing and Market Analysis.

[6] Pfizer Annual Report 2022.