Gilteritinib fumarate - Generic Drug Details

What are the generic drug sources for gilteritinib fumarate and what is the scope of freedom to operate?

Gilteritinib fumarate is the generic ingredient in one branded drug marketed by Astellas and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Gilteritinib fumarate has seventy-seven patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for gilteritinib fumarate

International Patents:	77
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	14
Clinical Trials:	3
Patent Applications:	45
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for gilteritinib fumarate
DailyMed Link:	gilteritinib fumarate at DailyMed

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

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 gilteritinib fumarate

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1
City of Hope Medical Center	Phase 1
Children's Oncology Group	Phase 3

See all gilteritinib fumarate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for gilteritinib fumarate

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for GILTERITINIB FUMARATE

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 gilteritinib fumarate

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

International Patents for gilteritinib fumarate

Country	Patent Number	Title	Estimated Expiration
Lithuania	PA2020002
Taiwan	I756177
Portugal	3009428
Lithuania	3009428

Supplementary Protection Certificates for gilteritinib fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2428508	2090007-2	Sweden		PRODUCT NAME: GILTERITINIB OR A SALT THEROF; REG. NO/DATE: EU/1/19/1399 20191028
2428508	PA2020002	Lithuania		PRODUCT NAME: GILTERITINIBAS; REGISTRATION NO/DATE: EU/1/19/1399 20191024
2428508	301028	Netherlands		PRODUCT NAME: GILTERITINIB OF EEN ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/19/13177 20191028
2428508	2020001	Norway		PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAV; REG. NO/DATE: EU/1/19/1399 20191030

Market Dynamics and Financial Trajectory for Gilteritinib Fumarate

Introduction

Gilteritinib fumarate, marketed as Xospata, is a significant advancement in the treatment of acute myeloid leukemia (AML) with FLT3 mutations. This article delves into the market dynamics and financial trajectory of gilteritinib, highlighting its impact, market size, and future projections.

Mechanism and Clinical Use

Gilteritinib fumarate is a pyrazinecarboxamide derivative that inhibits FLT3 and other receptor tyrosine kinases, particularly effective against FLT3-activating mutations in AML. It is used to treat adult patients with relapsed or refractory (R/R) FLT3 mutation-positive AML[2][4][5].

Market Size and Growth

The global FLT3 inhibitors market, which includes gilteritinib, was valued at USD 487.53 million in 2023 and is expected to reach USD 1,234.03 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 10.87% during the forecast period (2024-2032)[3].

Regional Market Share

• North America: This region is the largest shareholder in the global FLT3 inhibitors market, anticipated to grow at a CAGR of 14.41% during the forecast period. The U.S. and Canada dominate this market due to high acceptance rates among patients and physicians, as well as significant investments in research and development[3].
• Europe: Expected to grow at a CAGR of 14.04%, Europe is another key market. Countries like Germany, France, the U.K., Italy, and Spain are actively involved in enhancing FLT3 mutated cancer treatments through extensive research[3].
• Emerging Markets: Regions such as Asia-Pacific, Middle East and Africa, and Latin America are expected to be highly lucrative in the future due to the increasing demand for targeted therapeutics and the need for better access to these treatments in low- and middle-income economies[3].

Financial Impact on Health Plans

A budget impact analysis from a US payer's perspective indicates that the introduction of gilteritinib has a minimal budget impact. In a hypothetical health plan with 1 million members, the total plan budget increased by $663,795 in the first year, with a per-member-per-month (PMPM) cost increase of $0.055. In subsequent years, as the market share of gilteritinib increased to 45%, the total plan budget impact rose to $1,078,371 and $1,087,230, respectively, with PMPM costs increasing to $0.090 and $0.091[1].

Key Drivers of Market Growth

• Increasing Prevalence of AML: The growing incidence of AML worldwide drives the demand for effective targeted therapies like FLT3 inhibitors[3].
• Advancements in Research and Development: Continuous improvements in the research and development of targeted drugs for treating cancers with FLT3-positive mutations are a significant driver. Companies like Astellas Pharma Inc. are at the forefront of these advancements[3][4].
• Regulatory Approvals: Gilteritinib has been approved in several countries, including the U.S., Canada, Japan, Europe, and China, which has expanded its market reach[3][4].

Competitive Landscape

The global FLT3 inhibitors market is dominated by Type 1 FLT3 inhibitors, with Xospata (gilteritinib) and Rydapt (midostaurin) being the primary products. Xospata, developed by Astellas Pharma Inc., is a second-generation Type 1 tyrosine kinase inhibitor with exclusive rights for manufacture and commercialization worldwide[3].

Challenges and Limitations

• Access in Emerging Economies: Despite the growing demand, there is limited access to these drugs in low- and middle-income economies, which hampers market growth in these regions[3].
• Regulatory and Clinical Assumptions: The financial impact and market dynamics are contingent upon various assumptions, including regulatory approvals, clinical guidelines, and market research data[1].

Future Projections

The global FLT3 inhibitors market is poised for significant growth, driven by the increasing prevalence of AML and advancements in targeted therapies. As research and development continue to advance, the market is expected to expand, particularly in emerging regions.

"The global FLT3 inhibitors market size was valued at USD 487.53 million in 2023 and is expected to reach USD 1,234.03 million in 2032, growing at a CAGR of 10.87% over the forecast period (2024-32)"[3].

Key Takeaways

• Gilteritinib fumarate is a crucial drug in the treatment of R/R FLT3 mutation-positive AML.
• The global FLT3 inhibitors market is growing rapidly, driven by increasing AML prevalence and advancements in targeted therapies.
• North America and Europe are the largest markets, with emerging regions offering significant future growth opportunities.
• The financial impact on health plans is minimal, despite the increasing market share of gilteritinib.
• Access to these drugs in low- and middle-income economies remains a challenge.

FAQs

What is gilteritinib fumarate used for?

Gilteritinib fumarate, marketed as Xospata, is used to treat adult patients with relapsed or refractory (R/R) FLT3 mutation-positive acute myeloid leukemia (AML)[2][4][5].

How does gilteritinib fumarate work?

Gilteritinib fumarate inhibits FLT3 and other receptor tyrosine kinases, particularly effective against FLT3-activating mutations in AML[2][4][5].

What is the current market size of the global FLT3 inhibitors market?

The global FLT3 inhibitors market was valued at USD 487.53 million in 2023[3].

What is the projected growth rate of the global FLT3 inhibitors market?

The market is expected to grow at a CAGR of 10.87% from 2024 to 2032[3].

Which regions are expected to be highly lucrative for FLT3 inhibitors in the future?

Emerging regions such as Asia-Pacific, Middle East and Africa, and Latin America are expected to be highly lucrative markets in the future[3].

Last updated: 2024-12-23