Prescription medicine
Lenvatinib Brand names: Lenvima
Lenvatinib (Lenvima) is a prescription medicine with an FDA approval on record since 2015. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the lenvatinib FDA label on DailyMed (effective June 30, 2026, Eisai Inc.); the NDA 206947 record on Drugs@FDA; every lenvatinib label on DailyMed.
Highlights of the record
FDA label of June 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageLENVIMA is a kinase inhibitor that is indicated: Differentiated Thyroid Cancer (DTC) For the treatment of adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).
Forms and strengths
- 4 mg
- 10 mg
Capsule; kit.
On the market
- Earliest approval on file
- February 13, 2015 Lenvima, Eisai Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 15, 2038 Lenvima 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
- FAERS reports
- 32,614 through July 30, 2026
What is lenvatinib used for?
From the label: indications and usageLENVIMA is a kinase inhibitor that is indicated: Differentiated Thyroid Cancer (DTC) For the treatment of adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). ( 1.1 ) Renal Cell Carcinoma (RCC) In combination with pembrolizumab, for the first line treatment of adult patients with advanced renal cell carcinoma (RCC). ( 1.2 ) In combination with everolimus, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy. ( 1.2 ) Hepatocellular Carcinoma (HCC) For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). […]
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Lenvima), Eisai Inc., effective June 30, 2026 (SPL set f4bedd21-efde-44c6-9d9c-b48b78d7ed1e), via openFDA; the full label on DailyMed
Is there a generic for lenvatinib (Lenvima)?
No generic lenvatinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 10 patents for Lenvima capsules: the compound patent runs to August 26, 2035 (pediatric exclusivity to February 26, 2036), and the last listed entry to November 15, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 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 does the lenvatinib label say about other medicines?
The lenvatinib label names 4 other medicines 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 |
|---|---|---|
| Denosumab | warnings and precautions | Concomitant exposure to other risk factors, such as bisphosphonates, denosumab, dental disease or invasive dental procedures, may increase the risk of ONJ. |
| Everolimus | warnings and precautions | In Study 205 (RCC), QTc interval increases of >60 ms occurred in 11% of patients receiving LENVIMA with everolimus and QTc interval >500 ms occurred in 6%. |
| Pembrolizumab | warnings and precautions | Among patients receiving LENVIMA with pembrolizumab, arterial thrombotic events of any severity occurred in 5% of patients in CLEAR, including myocardial infarction (3.4%) and cerebrovascular accident (2.3%). |
| Sorafenib | warnings and precautions | Two percent of patients discontinued LENVIMA and 0.2% discontinued sorafenib due to hepatic encephalopathy and 1% of patients discontinued LENVIMA or sorafenib due to hepatic failure [see Adverse Reactions ( 6.1 )]. |
Source: FDA drug label (Lenvima), Eisai Inc., effective June 30, 2026 (SPL set f4bedd21-efde-44c6-9d9c-b48b78d7ed1e), via openFDA; the full label on DailyMed
What do FAERS reports show for lenvatinib?
The FDA Adverse Event Reporting System holds 32,614 reports that list lenvatinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,443 are coded as a death and 19,735 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
- Lenvatinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other