Prescription medicine
Tivozanib Brand names: Fotivda
Tivozanib (Fotivda) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the tivozanib FDA label on DailyMed (effective October 1, 2025, AVEO Pharmaceuticals, Inc.); the NDA 212904 record on Drugs@FDA; every tivozanib label on DailyMed.
Highlights of the record
FDA label of October 1, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageFOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
Forms and strengths
- 0.89 mg
- 1.34 mg
Capsule.
On the market
- Earliest approval on file
- March 10, 2021 Fotivda, Aveo Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 Fotivda capsules; 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 tivozanib used for?
From the label: indications and usageFOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (FOTIVDA), AVEO Pharmaceuticals, Inc., effective October 1, 2025 (SPL set de77155c-ecf2-4f15-9758-21d271449d83), via openFDA; the full label on DailyMed
Is there a generic for tivozanib (Fotivda)?
No generic tivozanib 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 2 patents for Fotivda capsules: the compound patent runs to November 16, 2028, 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.
- 2021 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 does the tivozanib label say about other medicines?
The tivozanib label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | warnings and precautions | Although the overall incidence of FD&C Yellow No.5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. |
Source: FDA drug label (FOTIVDA), AVEO Pharmaceuticals, Inc., effective October 1, 2025 (SPL set de77155c-ecf2-4f15-9758-21d271449d83), via openFDA; the full label on DailyMed
What next?
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other