Prescription medicine
Futibatinib Brand names: Lytgobi
Futibatinib (Lytgobi) is a prescription medicine with an FDA approval on record since 2022. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: futibatinib labels on DailyMed; the NDA 214801 record on Drugs@FDA; every futibatinib label on DailyMed.
Highlights of the record
no current FDA label; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
The label in openFDA carries no indications section.
Forms and strengths
- 4 mg
- 16 mg
Tablet.
On the market
- Earliest approval on file
- September 30, 2022 Lytgobi, Taiho Oncology; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- November 5, 2039 Lytgobi tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 204 through July 30, 2026
Is there a generic for futibatinib (Lytgobi)?
No generic futibatinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Lytgobi tablets: the compound patent runs to March 31, 2036, and the last listed entry to November 5, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2022 earliest approval on file
- 2039 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for futibatinib?
The FDA Adverse Event Reporting System holds 204 reports that list futibatinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 42 are coded as a death and 63 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Futibatinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other