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LYTGOBI

Futibatinib · Tablet

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
LYTGOBI
Generic name
Futibatinib
Dosage form
Tablet
Route
Oral
Marketing category
NDA · NDA
Labeler
TAIHO PHARMACEUTICAL CO., LTD.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
4
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Futibatinib 16 mg/1 2628195 —
Futibatinib 4 mg/1 2628195 —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Breast Cancer Resistance Protein Inhibitors [MoA] MoA All 44 members
Fibroblast Growth Factor Receptor Inhibitors [MoA] MoA 2 members — no class page
Kinase Inhibitor [EPC] EPC All 89 members
P-Glycoprotein Inhibitors [MoA] MoA All 105 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
214801
Application type
NDA · New Drug Application
Approval date
September 30, 2022
Sponsor
TAIHO ONCOLOGY
Products on application
2
Submissions recorded
3
Products approved under application 214801.
Product Trade name Form Strength Ingredient Status TE Flags
214801-001 LYTGOBI TABLET FUTIBATINIB Prescription — RLD RS
214801-002 LYTGOBI TABLET FUTIBATINIB Discontinued — RLD

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
9108973 February 13, 2033 001 Yes U-3456 October 24, 2022
9108973 February 13, 2033 002 Yes U-3456 September 11, 2025
10434103 March 31, 2036 001 Yes October 24, 2022
10434103 March 31, 2036 002 Yes September 11, 2025
11833151 November 5, 2039 001 No January 3, 2024
11833151 November 5, 2039 002 No September 11, 2025
Regulatory exclusivity periods.
Code Expires Product
NCE September 30, 2027 001
NCE September 30, 2027 002
ODE-410 September 30, 2029 001
ODE* September 30, 2029 002

Approval history

Source: Drugs@FDA
Most recent submissions on application 214801.
Type No. Action Status Date Review
Supplement 5 Labeling Approved October 15, 2025 Standard
Supplement 2 Labeling Approved April 17, 2024 Standard
Original application 1 Type 1 - New Molecular Entity Approved September 30, 2022 Priority

Review documents

  • 0 · Supplement · October 16, 2025
  • 0 · Supplement · October 16, 2025
  • 0 · Supplement · April 19, 2024
  • 0 · Supplement · April 18, 2024
  • 0 · Original application · November 8, 2022
  • 0 · Original application · October 6, 2022
  • 0 · Original application · October 5, 2022

Adverse event reports

Source: openFDA FAERS
204
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: FUTIBATINIB. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
64842-0120-4 64842-0120 TAIHO PHARMACEUTICAL CO., LTD. 1 BLISTER PACK in 1 CARTON (64842-0120-4) / 21 TABLET in 1 BLISTER PACK February 3, 2023
64842-0120-5 64842-0120 TAIHO PHARMACEUTICAL CO., LTD. 1 BLISTER PACK in 1 CARTON (64842-0120-5) / 28 TABLET in 1 BLISTER PACK February 3, 2023
64842-0120-6 64842-0120 TAIHO PHARMACEUTICAL CO., LTD. 1 BLISTER PACK in 1 CARTON (64842-0120-6) / 35 TABLET in 1 BLISTER PACK February 3, 2023
64842-0127-7 64842-0127 TAIHO PHARMACEUTICAL CO., LTD. 1 BLISTER PACK in 1 CARTON (64842-0127-7) / 7 TABLET in 1 BLISTER PACK June 1, 2026
64842-0120 64842-0120 TAIHO PHARMACEUTICAL CO., LTD. — February 3, 2023
64842-0127 64842-0127 TAIHO PHARMACEUTICAL CO., LTD. — June 1, 2026

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.