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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 usage

RETEVMO ® 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May 8, 2020 Retevmo, Eli Lilly And Co; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 usage

RETEVMO ® 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 labels

Lung 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 namedSectionWhat the label says
Prednisonewarnings and precautionsIf hypersensitivity occurs, withhold RETEVMO and begin corticosteroids at a dose of 1 mg/kg prednisone (or equivalent).

Check selpercatinib against other medicines

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.

MedicineShared indicationGeneric labelers (oral)Pharmacy costShortage
ErlotinibLung cancer10 labelersn/aNo current entry
AfatinibLung cancer1 labelern/aNo current entry
CrizotinibLung cancernone listedn/aNo current entry
GefitinibLung cancer4 labelersn/aNo current entry
BrigatinibLung cancernone listedn/aNo current entry
DabrafenibLung cancernone listedn/aNo current entry
LorlatinibLung cancernone listedn/aA presentation being discontinued
TrametinibLung cancernone listedn/aNo 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