Prescription medicine
Erdafitinib Brand names: Balversa
Erdafitinib (Balversa) is a prescription medicine with an FDA approval on record since 2019. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the erdafitinib FDA label on DailyMed (effective October 24, 2025, Janssen Products LP); the NDA 212018 record on Drugs@FDA; every erdafitinib label on DailyMed.
Highlights of the record
FDA label of October 24, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageBALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy.
Forms and strengths
- 3 mg
- 4 mg
- 5 mg
Film-coated tablet.
On the market
- Earliest approval on file
- April 12, 2019 Balversa, Janssen Biotech; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- February 2, 2038 Balversa 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
- 1,215 through July 30, 2026
What is erdafitinib used for?
From the label: indications and usageBALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA [see Dosage and Administration (2.1) and Clinical Studies (14.1) ]. BALVERSA is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. […]
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (BALVERSA), Janssen Products LP, effective October 24, 2025 (SPL set 2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee), via openFDA; the full label on DailyMed
Is there a generic for erdafitinib (Balversa)?
No generic erdafitinib is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 9 patents for Balversa tablets: the compound patent runs to April 12, 2033, and the last listed entry to February 2, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2038 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 erdafitinib?
The FDA Adverse Event Reporting System holds 1,215 reports that list erdafitinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 342 are coded as a death and 256 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.
Reports received each year
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
- Erdafitinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other