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Last Updated: July 18, 2025

XOSPATA Drug Patent Profile


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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

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Drug patent expirations by year for XOSPATA
Drug Prices for XOSPATA

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for XOSPATA
Generic Entry Date for XOSPATA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Kura Oncology, Inc.Phase 1
Acute Leukemia French AssociationPhase 2
French Innovative Leukemia OrganisationPhase 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XOSPATA is ⤷  Try for Free.

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 ⤷  Try for Free ⤷  Try for Free
Astellas XOSPATA gilteritinib fumarate TABLET;ORAL 211349-001 Nov 28, 2018 RX Yes Yes 11,938,131 ⤷  Try for Free Y ⤷  Try for Free
Astellas XOSPATA gilteritinib fumarate TABLET;ORAL 211349-001 Nov 28, 2018 RX Yes Yes 11,938,130 ⤷  Try for Free Y ⤷  Try for Free
Astellas XOSPATA gilteritinib fumarate TABLET;ORAL 211349-001 Nov 28, 2018 RX Yes Yes 11,938,132 ⤷  Try for Free Y ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 89534
Patent: COMPOSITION PHARMACEUTIQUE STABLE POUR ADMINISTRATION PAR VOIE ORALE (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷  Try for Free

China

Patent: 7847500
Patent: 稳定的口服给药用药物组合物 (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINSITRATION)
Estimated Expiration: ⤷  Try for Free

Croatia

Patent: 0230253
Estimated Expiration: ⤷  Try for Free

Denmark

Patent: 18259
Estimated Expiration: ⤷  Try for Free

European Patent Office

Patent: 18259
Patent: COMPOSITION PHARMACEUTIQUE STABLE POUR ADMINISTRATION PAR VOIE ORALE (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷  Try for Free

Patent: 30208
Patent: COMPOSITION PHARMACEUTIQUE STABLE POUR ADMINISTRATION ORALE (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷  Try for Free

Finland

Patent: 18259
Estimated Expiration: ⤷  Try for Free

Hong Kong

Patent: 48544
Patent: 穩定的口服給藥用藥物組合物 (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷  Try for Free

Hungary

Patent: 61697
Estimated Expiration: ⤷  Try for Free

Japan

Patent: 2017006855
Patent: 安定な経口投与用医薬組成物
Estimated Expiration: ⤷  Try for Free

Patent: 32294
Estimated Expiration: ⤷  Try for Free

Patent: 98400
Estimated Expiration: ⤷  Try for Free

Patent: 17119728
Patent: 安定な経口投与用医薬組成物 (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷  Try for Free

Lithuania

Patent: 18259
Estimated Expiration: ⤷  Try for Free

Mexico

Patent: 17016862
Patent: COMPOSICION FARMACEUTICA ESTABLE PARA ADMINISTRACION ORAL. (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINSITRATION.)
Estimated Expiration: ⤷  Try for Free

Philippines

Patent: 017502252
Patent: STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION
Estimated Expiration: ⤷  Try for Free

Poland

Patent: 18259
Estimated Expiration: ⤷  Try for Free

Portugal

Patent: 18259
Estimated Expiration: ⤷  Try for Free

Russian Federation

Patent: 64750
Patent: СТАБИЛЬНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕНИЯ (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷  Try for Free

Patent: 18103354
Patent: СТАБИЛЬНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕНИЯ
Estimated Expiration: ⤷  Try for Free

Serbia

Patent: 070
Patent: STABILNA FARMACEUTSKA KOMPOZICIJA ZA ORALNU ADMINISTRACIJU (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Estimated Expiration: ⤷  Try for Free

Slovenia

Patent: 18259
Estimated Expiration: ⤷  Try for Free

South Korea

Patent: 2685890
Estimated Expiration: ⤷  Try for Free

Patent: 180023914
Patent: 안정된 경구 투여용 의약 조성물
Estimated Expiration: ⤷  Try for Free

Spain

Patent: 40306
Estimated Expiration: ⤷  Try for Free

Taiwan

Patent: 56177
Estimated Expiration: ⤷  Try for Free

Patent: 1716069
Patent: Stable pharmaceutical composition for oral administration
Estimated Expiration: ⤷  Try for Free

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 ⤷  Try for Free
Mexico 2017016862 COMPOSICION FARMACEUTICA ESTABLE PARA ADMINISTRACION ORAL. (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINSITRATION.) ⤷  Try for Free
Luxembourg C00147 ⤷  Try for Free
Portugal 3009428 ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XOSPATA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2428508 8/2020 Austria ⤷  Try for Free PRODUCT NAME: GILTERITINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1399 (MITTEILUNG) 20191028
2428508 C202030004 Spain ⤷  Try for Free 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 ⤷  Try for Free PRODUCT NAME: GILTERITINIBAS; REGISTRATION NO/DATE: EU/1/19/1399 20191024
2428508 122020000004 Germany ⤷  Try for Free PRODUCT NAME: GILTERITINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1399 20191024
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.