Prescription medicine
Selpercatinib Brand names: Retevmo
Selpercatinib (Retevmo) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the selpercatinib FDA label on DailyMed (effective July 14, 2026, Eli Lilly and Company); the NDA 213246 record on Drugs@FDA; every selpercatinib label on DailyMed.
Highlights of the record
FDA label of July 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageRETEVMO ® is a kinase inhibitor indicated for the treatment of: Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test ( 1.1 ) Adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test
Forms and strengths
- 40 mg
- 80 mg
- 120 mg
- 160 mg
Coated tablet; capsule.
On the market
- Earliest approval on file
- May 8, 2020 Retevmo, Eli Lilly And Co; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- April 10, 2039 Retevmo 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 selpercatinib used for?
From the label: indications and usageRETEVMO ® is a kinase inhibitor indicated for the treatment of: Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test ( 1.1 ) Adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy ( 1.2 ) Adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if […]
Conditions named in the indications of selpercatinib's FDA labels, with every medicine labeled for each:
From other selpercatinib labelsLung cancer: RET Fusion-Positive Non-Small Cell Lung Cancer RETEVMO ® is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as …
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (RETEVMO), Eli Lilly and Company, effective July 14, 2026 (SPL set 7fa848ba-a59c-4144-9f52-64d090f4d828), via openFDA; the full label on DailyMed
Is there a generic for selpercatinib (Retevmo)?
No generic selpercatinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Retevmo tablets: the compound patent runs to October 10, 2037 (pediatric exclusivity to April 10, 2038), and the last listed entry to April 10, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 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 selpercatinib label say about other medicines?
The selpercatinib 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 |
|---|---|---|
| Prednisone | warnings and precautions | If hypersensitivity occurs, withhold RETEVMO and begin corticosteroids at a dose of 1 mg/kg prednisone (or equivalent). |
Source: FDA drug label (RETEVMO), Eli Lilly and Company, effective July 14, 2026 (SPL set 7fa848ba-a59c-4144-9f52-64d090f4d828), via openFDA; the full label on DailyMed
What else is labeled for the same conditions as selpercatinib?
26 other medicines are given the same way (oral) and in the same FDA class as selpercatinib or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Erlotinib | Lung cancer | 10 labelers | n/a | No current entry |
| Afatinib | Lung cancer | 1 labeler | n/a | No current entry |
| Crizotinib | Lung cancer | none listed | n/a | No current entry |
| Gefitinib | Lung cancer | 4 labelers | n/a | No current entry |
| Brigatinib | Lung cancer | none listed | n/a | No current entry |
| Dabrafenib | Lung cancer | none listed | n/a | No current entry |
| Lorlatinib | Lung cancer | none listed | n/a | A presentation being discontinued |
| Trametinib | Lung cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as selpercatinib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to selpercatinib
- 26 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other