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LYTGOBI

NDA

FUTIBATINIB | N214801 | TAIHO ONCOLOGY INC

2 strengths3 unique patents3 unique exclusivities

Patent Timeline

3 unique patents, 3 exclusivities by expiration date

Active (3)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

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2040

Today

9108973

Feb. 13, 2033

10434103

Mar. 31, 2036

11833151

Nov. 5, 2039

NCE

Sep. 30, 2027

ODE-410

Sep. 30, 2029

ODE*

Sep. 30, 2029

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

7 trials from ClinicalTrials.gov — 3 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets)NCT03767075	Phase 2	Recruiting	Vall d'Hebron Institute of Oncology	1,000	2018-12-10 → 2026-11
TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer NCT02693535	Phase 2	Recruiting	American Society of Clinical Oncology	4,200	2016-03-14 → 2028-12-31
European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors NCT02813135	Phase 1/2	Recruiting	Gustave Roussy, Cancer Campus, Grand Paris	472	2016-08-03 → 2031-02
A Study of TAS-120 in Patients With Advanced Solid Tumors NCT02052778	Phase 1/2	Completed	Taiho Oncology, Inc.	407	2014-07-21 → 2024-10-22
Futibatinib in Patients With Specific FGFR Aberrations NCT04189445	Phase 2	Terminated	Taiho Oncology, Inc.	115	2020-08-05 → 2024-11-11
Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements NCT04093362	Phase 3	Terminated	Taiho Oncology, Inc.	10	2021-01-06 → 2024-04-22
A Study of TAS-120 in Patients With Metastatic Breast Cancer NCT04024436	Phase 2	Terminated	Taiho Oncology, Inc.	64	2020-01-28 → 2023-09-06

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

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (3 FSS)

Lowest Price

$4389.59

Highest Price

$4448.32

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
64842-0120-04LYTGOBI 4MG X 3 (12MG) DAILY PKT,21	$4401.27	FSS	Taiho Oncology, Inc.	03/31/2027
64842-0120-05LYTGOBI 4MG X 4 (16MG) DAILY PKT,28	$4389.59	FSS	Taiho Oncology, Inc.	03/31/2027
64842-0120-06LYTGOBI 4MG X 5 (20MG) DAILY PKT,35	$4448.32	FSS	Taiho Oncology, Inc.	03/31/2027

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

Medicare Part D Spending

CMS annual spending data for Lytgobi (2024)

Total Spending

$21.8M

Total Claims

952

Beneficiaries

215

Avg Cost/Unit

$195.00

Spending Trend

$7.2M(2023)→$21.8M(2024)

YoY Change:+2.5%

5yr CAGR:+2.5%

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Oct 16, 2025	SUPPL -5	View Letter (PDF)
Apr 18, 2024	SUPPL -2	View Letter (PDF)
Oct 6, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 4MG

RLD

3 patents2 exclusivities▴

TABLET;ORAL | Approved: Sep 30, 2022

Patents (3) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9108973	Feb 13, 2033	—	Yes	Yes		—
10434103	Mar 31, 2036	—	Yes	Yes	—	—
11833151	Nov 5, 2039	—	—	Yes	—	—

Exclusivities (2)

Code	Date	Status
NCE	Sep 30, 2027	Active
ODE-410	Sep 30, 2029	Active

#002 — 16MG

RLD

3 patents2 exclusivities▾

TABLET;ORAL | Approved: Jul 28, 2025