# RETEVMO — FDA application NDA213246

Informational only - not investment advice.

Application NDA213246 · type NDA · FDA status: approved · original approval 2020-05-08

Listed sponsor: ELI LILLY AND CO · [LLY company profile](/company/LLY/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | RETEVMO | SELPERCATINIB | CAPSULE | ORAL | 40MG | Prescription | not listed | Yes |
| 002 | RETEVMO | SELPERCATINIB | CAPSULE | ORAL | 80MG | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 10112942, product 001; listed patent expiry date: 2037-10-10.
- Patent 10112942, product 002; listed patent expiry date: 2037-10-10.
- Patent 10137124, product 001; listed patent expiry date: 2037-10-10.
- Patent 10137124, product 001; listed patent expiry date: 2037-10-10.
- Patent 10137124, product 001; listed patent expiry date: 2037-10-10.
- Patent 10137124, product 001; listed patent expiry date: 2037-10-10.
- Patent 10137124, product 002; listed patent expiry date: 2037-10-10.
- Patent 10137124, product 002; listed patent expiry date: 2037-10-10.
- Patent 10137124, product 002; listed patent expiry date: 2037-10-10.
- Patent 10137124, product 002; listed patent expiry date: 2037-10-10.
- Patent 10172851, product 001; listed patent expiry date: 2037-10-10.
- Patent 10172851, product 001; listed patent expiry date: 2037-10-10.
- Patent 10172851, product 001; listed patent expiry date: 2037-10-10.
- Patent 10172851, product 001; listed patent expiry date: 2037-10-10.
- Patent 10172851, product 002; listed patent expiry date: 2037-10-10.
- Patent 10172851, product 002; listed patent expiry date: 2037-10-10.
- Patent 10172851, product 002; listed patent expiry date: 2037-10-10.
- Patent 10172851, product 002; listed patent expiry date: 2037-10-10.
- Patent 10112942, product 001; listed patent expiry date: 2038-04-10.
- Patent 10112942, product 002; listed patent expiry date: 2038-04-10.
- Patent 10137124, product 001; listed patent expiry date: 2038-04-10.
- Patent 10137124, product 002; listed patent expiry date: 2038-04-10.
- Patent 10172851, product 001; listed patent expiry date: 2038-04-10.
- Patent 10172851, product 002; listed patent expiry date: 2038-04-10.
- Patent 10584124, product 001; listed patent expiry date: 2038-10-10.
- Patent 10584124, product 001; listed patent expiry date: 2038-10-10.
- Patent 10584124, product 001; listed patent expiry date: 2038-10-10.
- Patent 10584124, product 001; listed patent expiry date: 2038-10-10.
- Patent 10584124, product 002; listed patent expiry date: 2038-10-10.
- Patent 10584124, product 002; listed patent expiry date: 2038-10-10.
- Patent 10584124, product 002; listed patent expiry date: 2038-10-10.
- Patent 10584124, product 002; listed patent expiry date: 2038-10-10.
- Patent 10786489, product 001; listed patent expiry date: 2038-10-10.
- Patent 10786489, product 001; listed patent expiry date: 2038-10-10.
- Patent 10786489, product 001; listed patent expiry date: 2038-10-10.
- Patent 10786489, product 001; listed patent expiry date: 2038-10-10.
- Patent 10786489, product 002; listed patent expiry date: 2038-10-10.
- Patent 10786489, product 002; listed patent expiry date: 2038-10-10.
- Patent 10786489, product 002; listed patent expiry date: 2038-10-10.
- Patent 10786489, product 002; listed patent expiry date: 2038-10-10.
- Patent 12138250, product 001; listed patent expiry date: 2038-10-10.
- Patent 12138250, product 001; listed patent expiry date: 2038-10-10.
- Patent 12138250, product 001; listed patent expiry date: 2038-10-10.
- Patent 12138250, product 001; listed patent expiry date: 2038-10-10.
- Patent 12138250, product 002; listed patent expiry date: 2038-10-10.
- Patent 12138250, product 002; listed patent expiry date: 2038-10-10.
- Patent 12138250, product 002; listed patent expiry date: 2038-10-10.
- Patent 12138250, product 002; listed patent expiry date: 2038-10-10.
- Patent 10584124, product 001; listed patent expiry date: 2039-04-10.
- Patent 10584124, product 002; listed patent expiry date: 2039-04-10.
- Patent 10786489, product 001; listed patent expiry date: 2039-04-10.
- Patent 10786489, product 002; listed patent expiry date: 2039-04-10.
- Patent 12138250, product 001; listed patent expiry date: 2039-04-10.
- Patent 12138250, product 002; listed patent expiry date: 2039-04-10.
- Exclusivity ODE-301, product 001; listed exclusivity date: 2027-05-08.
- Exclusivity ODE-301, product 002; listed exclusivity date: 2027-05-08.
- Exclusivity ODE-302, product 001; listed exclusivity date: 2027-05-08.
- Exclusivity ODE-302, product 002; listed exclusivity date: 2027-05-08.
- Exclusivity ODE-303, product 001; listed exclusivity date: 2027-05-08.
- Exclusivity ODE-303, product 002; listed exclusivity date: 2027-05-08.
- Exclusivity NPP, product 001; listed exclusivity date: 2027-05-29.
- Exclusivity NPP, product 002; listed exclusivity date: 2027-05-29.
- Exclusivity M-311, product 001; listed exclusivity date: 2027-09-27.
- Exclusivity M-311, product 002; listed exclusivity date: 2027-09-27.
- Exclusivity M-312, product 001; listed exclusivity date: 2027-09-27.
- Exclusivity M-312, product 002; listed exclusivity date: 2027-09-27.
- Exclusivity PED, product 001; listed exclusivity date: 2027-11-08.
- Exclusivity PED, product 001; listed exclusivity date: 2027-11-08.
- Exclusivity PED, product 001; listed exclusivity date: 2027-11-08.
- Exclusivity PED, product 002; listed exclusivity date: 2027-11-08.
- Exclusivity PED, product 002; listed exclusivity date: 2027-11-08.
- Exclusivity PED, product 002; listed exclusivity date: 2027-11-08.
- Exclusivity PED, product 001; listed exclusivity date: 2027-11-29.
- Exclusivity PED, product 002; listed exclusivity date: 2027-11-29.
- Exclusivity PED, product 001; listed exclusivity date: 2028-03-27.
- Exclusivity PED, product 001; listed exclusivity date: 2028-03-27.
- Exclusivity PED, product 002; listed exclusivity date: 2028-03-27.
- Exclusivity PED, product 002; listed exclusivity date: 2028-03-27.
- Exclusivity ODE-409, product 001; listed exclusivity date: 2029-09-21.
- Exclusivity ODE-409, product 002; listed exclusivity date: 2029-09-21.
- Exclusivity ODE-412, product 001; listed exclusivity date: 2029-09-21.
- Exclusivity ODE-412, product 002; listed exclusivity date: 2029-09-21.
- Exclusivity PED, product 001; listed exclusivity date: 2030-03-21.
- Exclusivity PED, product 001; listed exclusivity date: 2030-03-21.
- Exclusivity PED, product 002; listed exclusivity date: 2030-03-21.
- Exclusivity PED, product 002; listed exclusivity date: 2030-03-21.
- Exclusivity ODE-484, product 001; listed exclusivity date: 2031-05-29.
- Exclusivity ODE-484, product 002; listed exclusivity date: 2031-05-29.
- Exclusivity ODE-485, product 001; listed exclusivity date: 2031-05-29.
- Exclusivity ODE-485, product 002; listed exclusivity date: 2031-05-29.
- Exclusivity ODE-487, product 001; listed exclusivity date: 2031-05-29.
- Exclusivity ODE-487, product 002; listed exclusivity date: 2031-05-29.
- Exclusivity PED, product 001; listed exclusivity date: 2031-11-29.
- Exclusivity PED, product 001; listed exclusivity date: 2031-11-29.
- Exclusivity PED, product 001; listed exclusivity date: 2031-11-29.
- Exclusivity PED, product 002; listed exclusivity date: 2031-11-29.
- Exclusivity PED, product 002; listed exclusivity date: 2031-11-29.
- Exclusivity PED, product 002; listed exclusivity date: 2031-11-29.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- SELPERCATINIB · UNII CEGM9YBNGD · no lmmol compound match

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/LLY/)
- [FDA-approved application index](/drug/)
- [Large-cap biopharma](/compare/pharma/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA213246. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.