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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Xospata (2023)

Total Spending

$89.8M

Total Claims

3,881

Beneficiaries

924

Avg Cost/Unit

$310.82

Spending Trend

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

YoY Change:+6.0%

5yr CAGR:+4.8%

Source: CMS Medicare Part D Spending by Drug (2023). 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)

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	—	—