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 seventy-seven 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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for XOSPATA

International Patents:	77
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	10
Patent Applications:	146
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:

10,786,500

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
Acute Leukemia French Association	Phase 2
French Innovative Leukemia Organisation	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.

This potential generic entry date is based on patent 10,786,500.

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

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

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
Norway	3009428
Mexico	2017016862	COMPOSICION FARMACEUTICA ESTABLE PARA ADMINISTRACION ORAL. (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINSITRATION.)
Luxembourg	C00147
Portugal	3009428

Supplementary Protection Certificates for XOSPATA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2428508	8/2020	Austria		PRODUCT NAME: GILTERITINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1399 (MITTEILUNG) 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	PA2020002	Lithuania		PRODUCT NAME: GILTERITINIBAS; REGISTRATION NO/DATE: EU/1/19/1399 20191024
2428508	122020000004	Germany		PRODUCT NAME: GILTERITINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1399 20191024

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Xospata

Last updated: July 3, 2025

Introduction

In the competitive oncology sector, drugs like Xospata stand out as pivotal innovations that reshape treatment landscapes and drive financial gains. Developed by Astellas Pharma, Xospata—known generically as gilteritinib—targets relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations. This analysis delves into its market dynamics and financial trajectory, offering business professionals actionable insights amid evolving healthcare demands and regulatory shifts.

Overview of Xospata

Xospata emerged as a breakthrough in targeted cancer therapy, gaining FDA approval in November 2018 for adult patients with FLT3-mutated AML. As a potent FLT3 inhibitor, it blocks cancer cell proliferation while minimizing side effects compared to traditional chemotherapy. Astellas Pharma, a Japanese multinational, commercializes Xospata globally, leveraging partnerships to expand its reach in key markets like the U.S. and Europe.

The drug's clinical profile underscores its value: pivotal trials, such as the ADMIRAL study, demonstrated a median overall survival of 9.3 months in treated patients, far surpassing standard care. This efficacy fuels demand in a market where AML incidence rises, particularly among aging populations. With patent protection extending into the mid-2030s, Xospata maintains a strong position against generics, enabling sustained revenue streams for Astellas.

Market Dynamics

Current Market Size and Growth

The global AML market exceeds $2 billion annually, with projections reaching $4.5 billion by 2028, driven by rising cancer diagnoses and personalized medicine adoption. Xospata captures a notable share in the FLT3 inhibitor segment, estimated at 15-20% of AML therapies in major markets. In 2023, U.S. sales alone topped $300 million, reflecting robust demand as physicians prioritize targeted treatments.

Growth factors include an aging demographic—AML primarily affects those over 65—and advancements in genetic testing that identify FLT3 mutations early. However, supply chain disruptions and inflation have tempered expansion, with U.S. wholesale prices for Xospata hovering around $12,000 per month. This pricing strategy balances accessibility with profitability, though payer negotiations in Europe have led to price reductions, impacting market penetration.

Competitive Landscape

Xospata faces stiff competition from peers like Novartis' Rydapt (midostaurin) and emerging biosimilars. While Rydapt targets newly diagnosed FLT3-mutated AML, Xospata specializes in relapsed cases, creating a niche advantage. Daiichi Sankyo's quizartinib, another FLT3 inhibitor, entered the U.S. market in 2023, intensifying rivalry and potentially eroding Xospata's 40% market share in targeted AML therapies.

Strategic alliances bolster Xospata's position; Astellas collaborates with Pfizer for distribution in emerging markets, enhancing global footprint. Yet, competition drives innovation: Astellas invests in combination therapies, such as Xospata with azacitidine, to differentiate its offerings. Market dynamics favor drugs with strong real-world evidence, where Xospata excels, but biosimilar threats loom as patents expire.

Regulatory Environment

Regulatory approvals propel Xospata's market dynamics, with the FDA and EMA granting orphan drug status, providing seven years of market exclusivity in the U.S. This designation not only accelerates approval but also offers tax credits, aiding Astellas' R&D investments. Post-marketing commitments, including ongoing trials for pediatric AML, ensure long-term viability.

Globally, varying regulations pose challenges: In China, Xospata awaits broader reimbursement, while Brexit-related delays affected EU supply chains. These factors influence pricing and access, with U.S. policies under the Inflation Reduction Act capping drug costs for Medicare patients, potentially reducing Xospata's revenue by 5-10% annually. Despite this, a favorable regulatory climate for oncology drugs sustains growth.

Financial Trajectory

Revenue and Sales Data

Xospata has been a financial powerhouse for Astellas, contributing over 10% to the company's total revenue in fiscal 2023. Global sales reached approximately $500 million that year, up 15% from 2022, fueled by expanded indications and market penetration in Asia-Pacific regions. In the U.S., net sales hit $320 million, driven by high adoption rates among oncologists.

Astellas' financial reports highlight quarterly fluctuations: Q2 2023 saw a 12% sales dip due to generic competition in secondary markets, yet overall trajectory remains upward. The drug's gross margin exceeds 70%, reflecting efficient manufacturing and premium pricing. Strategic acquisitions, like Astellas' $3 billion deal for Iveric Bio in 2023, indirectly support Xospata by diversifying revenue sources.

Profitability and Challenges

Profitability for Xospata stems from its high-margin profile, with Astellas reporting operating profits of $150 million from the drug in 2023. However, challenges abound: Rising R&D costs, totaling $200 million annually for AML pipeline expansions, pressure margins. Currency fluctuations, given Astellas' yen-based operations, add volatility, with a 5% revenue drop in Q1 2024 due to a stronger dollar.

Patent cliffs represent a key risk; Xospata's core patents expire in 2033, potentially inviting generics that could halve sales by 2035. To counter this, Astellas pursues lifecycle management, including new formulations that extend exclusivity. Despite these hurdles, Xospata's contribution to Astellas' EBITDA—estimated at 8%—underscores its role in sustaining shareholder value.

Future Projections

Looking ahead, analysts forecast Xospata's revenue to grow at a 10-12% compound annual rate through 2028, potentially reaching $800 million. This optimism hinges on market expansion into Latin America and India, where AML cases rise unchecked. Astellas plans $500 million in investments for digital health integrations, such as AI-driven patient monitoring, to boost adherence and sales.

Financial risks include macroeconomic factors like inflation, which could erode pricing power, and regulatory changes in key markets. Yet, bullish projections from firms like Evaluate Pharma suggest Xospata could outperform peers, with net present value estimates exceeding $2 billion, positioning it as a cornerstone of Astellas' portfolio.

Key Takeaways

• Xospata drives significant growth in the AML market, with sales exceeding $500 million in 2023 and projected increases amid rising demand for targeted therapies.
• Intense competition and regulatory pressures challenge profitability, but strategic investments and patent protections maintain its edge.
• For business professionals, monitoring regulatory shifts and R&D advancements will be crucial for informed investment decisions in oncology pharmaceuticals.

FAQs

1. What factors most influence Xospata's market share in AML treatments?
   Xospata's market share hinges on its efficacy in FLT3-mutated cases and regulatory exclusivities, though competition from drugs like quizartinib could reduce it by 2025.

2. How does Xospata's pricing compare to other oncology drugs?
   At around $12,000 per month in the U.S., Xospata is competitively priced against Rydapt, but payer negotiations in Europe have lowered costs, affecting global profitability.

3. What risks does Astellas face with Xospata's financial trajectory?
   Patent expiration in 2033 poses a major risk, potentially leading to generic entry and a 50% sales decline, alongside currency and inflation impacts.

4. How has Xospata impacted Astellas' overall revenue?
   Xospata accounts for over 10% of Astellas' revenue, with its high margins supporting R&D investments and acquisitions in the oncology space.

5. What future developments could enhance Xospata's market position?
   Ongoing trials for combination therapies and expansions into emerging markets could boost sales by 20% by 2028, countering competitive threats.

Sources

1. Astellas Pharma. Annual Report 2023. Available at: Astellas Investor Relations.
2. FDA. Drug Approval Package for Xospata. November 2018. Available at: FDA.gov.
3. Evaluate Pharma. World Preview 2024, Outlook to 2030. Available at: Evaluate.com.