Viewing data from:

XOSPATA

NDA

GILTERITINIB FUMARATE | N211349 | ASTELLAS PHARMA US INC

1 strength8 unique patents0 unique exclusivities

Patent Timeline

8 unique patents by expiration date

Active (8)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Nov. 28, 2032

Jul. 28, 2030

Jul. 1, 2036

Jul. 1, 2036

Jul. 1, 2036

Jul. 1, 2036

Jul. 1, 2036

Jul. 1, 2036

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ASTELLAS PHARMA INC. et al v. SANDOZ, INC. 2:2023cv01214 1 patentgilteritinib hemifumarate	D.N.J.	2023-03-02	Terminated 2025-02-21	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

15 trials from ClinicalTrials.gov — 4 recruiting, 3 active, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation NCT03182244	Phase 3	Active	Astellas Pharma Inc	276	2017-10-25 → 2027-03-31
Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia NCT03836209	Phase 2	Active	PrECOG, LLC.	181	2019-12-06 → 2026-07
A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy NCT04027309	Phase 3	Active	Stichting Hemato-Oncologie voor Volwassenen Nederland	777	2019-12-20 → 2033-06
A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations NCT04293562	Phase 3	Recruiting	Children's Oncology Group	1,186	2020-07-21 → 2029-06-30
Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm NCT04140487	Phase 1/2	Recruiting	M.D. Anderson Cancer Center	97	2019-12-17 → 2028-09-01
Study of Biomarker-Based Treatment of Acute Myeloid Leukemia NCT03013998	Phase 1/2	Recruiting	Beat AML, LLC	3,000	2016-11 → 2028-12
Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia NCT02115295	Phase 2	Recruiting	M.D. Anderson Cancer Center	508	2014-05-19 → 2030-05-31
A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia NCT02236013	Phase 1	Completed	Astellas Pharma Global Development, Inc.	80	2015-01-07 → 2021-07-26
A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia.NCT02310321	Phase 1/2	Completed	Astellas Pharma Inc	97	2015-02-26 → 2024-07-09
A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation NCT02421939	Phase 3	Completed	Astellas Pharma Global Development, Inc.	371	2015-10-20 → 2025-02-25

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$20350.63

Highest Price

$20350.63

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00469-1425-90XOSPATA 40MG TAB	$20350.63	FSS	Astellas Pharma U.S., Inc.	09/29/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Xospata (2024)

Total Spending

$106.4M

Total Claims

4,809

Beneficiaries

1,048

Avg Cost/Unit

$303.80

Spending Trend

$33.2M(2019)→$58.7M(2020)→$70.2M(2021)→$75.6M(2022)→$89.8M(2023)→$106.4M(2024)

YoY Change:-2.3%

5yr CAGR:+3.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MSN LABORATORIES PRIVATE LTDGILTERITINIB FUMARATE

DMF 367452022

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jan 13, 2022	SUPPL -3	View Letter (PDF)
Jun 4, 2019	SUPPL -1	View Letter (PDF)
Nov 30, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 40MG BASE

RLD

8 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 28, 2018

Patents (8) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8969336	Nov 28, 2032	—	Yes	Yes	—	—
9487491	Jul 28, 2030	—	—	—		—
10786500	Jul 1, 2036	—	—	Yes	—	—
11938130	Jul 1, 2036	—	—	Yes	—	—
11938131	Jul 1, 2036	—	—	Yes	—	—
11938132	Jul 1, 2036	—	—	Yes	—	—
11938133	Jul 1, 2036	—	—	Yes	—	—
11944620	Jul 1, 2036	—	—	Yes	—	—