Prescription medicine

Vorasidenib Brand names: Voranigo

Vorasidenib (Voranigo) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the vorasidenib FDA label on DailyMed (effective June 19, 2026, Servier Pharmaceuticals LLC); the NDA 218784 record on Drugs@FDA; every vorasidenib label on DailyMed.

Highlights of the record

FDA label of June 19, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
VORANIGO is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation, as detected by an FDA-approved test, following surgery including biopsy, sub-total resection, or gross total resection [see Dosage and Administration (2.1), Clinical Pharmacology (12.

Forms and strengths

10 mg
40 mg

Film-coated tablet.

On the market

Earliest approval on file: August 6, 2024 Voranigo, Servier; Drugs@FDA’s file, where older or withdrawn approvals can be missing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: January 16, 2039 Voranigo 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

What is vorasidenib used for?

From the label: indications and usage
VORANIGO is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation, as detected by an FDA-approved test, following surgery including biopsy, sub-total resection, or gross total resection [see Dosage and Administration (2.1), Clinical Pharmacology (12.1) and Clinical Studies (14) ]. […]

FDA pharmacologic class: Isocitrate Dehydrogenase 1 Inhibitor and Isocitrate Dehydrogenase 2 Inhibitor.

Source: FDA drug label (VORANIGO), Servier Pharmaceuticals LLC, effective June 19, 2026 (SPL set 31405fee-55b7-4857-987e-2724ee76be84), via openFDA; the full label on DailyMed

Is there a generic for vorasidenib (Voranigo)?

No generic vorasidenib is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 5 patents for Voranigo tablets: the compound patent runs to January 16, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2024 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 next?

Other isocitrate dehydrogenase 1 inhibitors: the pharmacologic class, with prices and generics
Check an interaction: what two or more labels say about each other