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XOSPATA Drug Patent Profile

When do Xospata patents expire, 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-five 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:	75
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	10
Patent Applications:	179
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

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
European Patent Office	2428508	COMPOSÉ DE CARBOXAMIDE HÉTÉROCYCLIQUE DIAMINO (DIAMINO HETEROCYCLIC CARBOXAMIDE COMPOUND)
Japan	2017119728	安定な経口投与用医薬組成物 (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Portugal	2428508
Hungary	S2000005

Supplementary Protection Certificates for XOSPATA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2428508	C02428508/01	Switzerland		PRODUCT NAME: GILTERITINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67211 24.09.2020
2428508	CR 2020 00006	Denmark		PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/19/1399 20191028
2428508	CA 2020 00006	Denmark		PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/19/1399 20191028
2428508	PA2020002,C2428508	Lithuania		PRODUCT NAME: GILTERITINIBAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/19/1399 20191024

XOSPATA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for XOSPATA (Gilteritinib)

Introduction

XOSPATA (gilteritinib) is a groundbreaking drug developed by Astellas Pharma Inc. for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a FMS-like tyrosine kinase 3 (FLT3) mutation. Here, we delve into the market dynamics and financial trajectory of this significant pharmaceutical product.

Approval and Launch

XOSPATA was approved by the U.S. Food and Drug Administration (FDA) on November 28, 2018, and subsequently launched in the United States for prescription[4]. It is also approved by the Japan Ministry of Health, Labor and Welfare (MHLW) for similar indications.

Market Size and Growth

The global FLT3 inhibitors market, which includes XOSPATA, is projected to experience substantial growth. By 2032, the market size is expected to reach USD 1,234.03 million, with a Compound Annual Growth Rate (CAGR) of 10.87% during the forecast period from 2024 to 2032. The Type 1 FLT3 inhibitors segment, where XOSPATA is categorized, is the highest contributor to this market and is expected to grow at a CAGR of 10.71%[1].

Regional Performance

North America is currently the largest market for FLT3 inhibitors, including XOSPATA, while Europe is identified as the fastest-growing region. This regional growth is driven by increasing awareness of the drug's efficacy and the expanding patient population with FLT3 mutations[1].

Sales Performance

XOSPATA has shown steady growth in sales. As of the financial results for FY2023, global sales of XOSPATA increased to JPY 55.1 billion, representing an 18% year-over-year (YoY) increase. This growth is consistent across all regions and aligns with the full-year forecast[5].

Competitive Landscape

XOSPATA is the first and only FDA-approved FLT3-targeting agent for the treatment of relapsed or refractory AML with FLT3 mutations. This unique positioning gives it a competitive edge in the market. However, it competes with other salvage chemotherapy regimens such as azacitidine, FLAG-IDA, MEC, and LDAC, as well as best supportive care (BSC)[3][4].

Economic Evaluation

The pharmacoeconomic report by CADTH highlights that XOSPATA is a cost-effective option compared to salvage chemotherapy and BSC, especially at higher willingness-to-pay thresholds. The report suggests that XOSPATA is the optimal therapy at a willingness-to-pay threshold of at least $168,451 per quality-adjusted life-year (QALY) gained. However, a price reduction would be necessary to achieve lower ICER thresholds[3].

Patient Support and Access

Astellas provides comprehensive patient support services for XOSPATA, including access and reimbursement support through XOSPATA Support SolutionsSM. This initiative helps patients access the drug as prescribed by their healthcare providers, enhancing its market penetration and patient adherence[4].

Clinical Trials and Future Prospects

Astellas is actively involved in several Phase 3 clinical trials investigating gilteritinib in various FLT3 mutation-positive AML patient populations. These ongoing trials aim to further establish the drug's efficacy and expand its indications, potentially driving future growth in the market[4].

Financial Impact on Astellas

The success of XOSPATA has contributed significantly to Astellas' revenue. Despite overall challenges in the company's financial performance, such as decreases in core operating profit and profit due to various factors including impairment losses and fair value adjustments, XOSPATA's sales growth has been a positive factor. The drug's performance has helped offset some of the declines in other product lines, such as the pharmacologic stress agent LEXISCAN[2][5].

Key Takeaways

• Market Growth: The global FLT3 inhibitors market, driven by XOSPATA, is expected to reach USD 1,234.03 million by 2032 with a CAGR of 10.87%.
• Regional Performance: North America is the largest market, while Europe is the fastest-growing region.
• Sales Performance: XOSPATA sales increased by 18% YoY to JPY 55.1 billion in FY2023.
• Competitive Edge: XOSPATA is the first FDA-approved FLT3-targeting agent, giving it a unique market position.
• Economic Evaluation: XOSPATA is cost-effective at higher willingness-to-pay thresholds.
• Patient Support: Comprehensive support services are available to enhance patient access.

FAQs

What is XOSPATA used for?

XOSPATA (gilteritinib) is used for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a FMS-like tyrosine kinase 3 (FLT3) mutation.

Who developed XOSPATA?

XOSPATA was developed by Astellas Pharma Inc. through a research collaboration with Kotobuki Pharmaceutical Co., Ltd.

When was XOSPATA approved by the FDA?

XOSPATA was approved by the U.S. Food and Drug Administration (FDA) on November 28, 2018.

How does XOSPATA compare to other treatments in terms of cost-effectiveness?

XOSPATA is considered cost-effective compared to salvage chemotherapy and best supportive care, especially at higher willingness-to-pay thresholds.

What are the ongoing clinical trials for XOSPATA?

Astellas is conducting several Phase 3 clinical trials to investigate gilteritinib in various FLT3 mutation-positive AML patient populations.

Sources

1. Straits Research: Global FLT3 Inhibitors Market Size, Top Share, Report to 2032.
2. Astellas: Financial Results of Astellas for the First Nine Months of FY2023.
3. CADTH: Pharmacoeconomic Report for Gilteritinib (XOSPATA).
4. Astellas: Astellas Launches XOSPATA® (gilteritinib) in the U.S. for the Treatment of Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) with a FLT3 Mutation.
5. Astellas: Financial Results for FY2023 - Astellas Pharma Inc.