RETEVMO — FDA application NDA213246
Listed sponsor: ELI LILLY AND CO · LLY company profile · 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 |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 10112942 | 001 | listed patent expiry date: 2037-10-10 | drug substance, drug product |
| Patent 10112942 | 002 | listed patent expiry date: 2037-10-10 | drug substance, drug product |
| Patent 10137124 | 001 | listed patent expiry date: 2037-10-10 | U-3450 |
| Patent 10137124 | 001 | listed patent expiry date: 2037-10-10 | U-3949 |
| Patent 10137124 | 001 | listed patent expiry date: 2037-10-10 | U-3950 |
| Patent 10137124 | 001 | listed patent expiry date: 2037-10-10 | U-3951 |
| Patent 10137124 | 002 | listed patent expiry date: 2037-10-10 | U-3450 |
| Patent 10137124 | 002 | listed patent expiry date: 2037-10-10 | U-3949 |
| Patent 10137124 | 002 | listed patent expiry date: 2037-10-10 | U-3951 |
| Patent 10137124 | 002 | listed patent expiry date: 2037-10-10 | U-3950 |
| Patent 10172851 | 001 | listed patent expiry date: 2037-10-10 | U-3450 |
| Patent 10172851 | 001 | listed patent expiry date: 2037-10-10 | U-3949 |
| Patent 10172851 | 001 | listed patent expiry date: 2037-10-10 | U-3950 |
| Patent 10172851 | 001 | listed patent expiry date: 2037-10-10 | U-3951 |
| Patent 10172851 | 002 | listed patent expiry date: 2037-10-10 | U-3951 |
| Patent 10172851 | 002 | listed patent expiry date: 2037-10-10 | U-3949 |
| Patent 10172851 | 002 | listed patent expiry date: 2037-10-10 | U-3950 |
| Patent 10172851 | 002 | listed patent expiry date: 2037-10-10 | U-3450 |
| Patent 10112942 | 001 | listed patent expiry date: 2038-04-10 | pediatric extension |
| Patent 10112942 | 002 | listed patent expiry date: 2038-04-10 | pediatric extension |
| Patent 10137124 | 001 | listed patent expiry date: 2038-04-10 | pediatric extension |
| Patent 10137124 | 002 | listed patent expiry date: 2038-04-10 | pediatric extension |
| Patent 10172851 | 001 | listed patent expiry date: 2038-04-10 | pediatric extension |
| Patent 10172851 | 002 | listed patent expiry date: 2038-04-10 | pediatric extension |
| Patent 10584124 | 001 | listed patent expiry date: 2038-10-10 | drug substance, U-3450 |
| Patent 10584124 | 001 | listed patent expiry date: 2038-10-10 | drug substance, U-3949 |
| Patent 10584124 | 001 | listed patent expiry date: 2038-10-10 | drug substance, U-3950 |
| Patent 10584124 | 001 | listed patent expiry date: 2038-10-10 | drug substance, U-3951 |
| Patent 10584124 | 002 | listed patent expiry date: 2038-10-10 | drug substance, U-3450 |
| Patent 10584124 | 002 | listed patent expiry date: 2038-10-10 | drug substance, U-3951 |
| Patent 10584124 | 002 | listed patent expiry date: 2038-10-10 | drug substance, U-3950 |
| Patent 10584124 | 002 | listed patent expiry date: 2038-10-10 | drug substance, U-3949 |
| Patent 10786489 | 001 | listed patent expiry date: 2038-10-10 | drug product, U-3450 |
| Patent 10786489 | 001 | listed patent expiry date: 2038-10-10 | drug product, U-3949 |
| Patent 10786489 | 001 | listed patent expiry date: 2038-10-10 | drug product, U-3951 |
| Patent 10786489 | 001 | listed patent expiry date: 2038-10-10 | drug product, U-3950 |
| Patent 10786489 | 002 | listed patent expiry date: 2038-10-10 | drug product, U-3450 |
| Patent 10786489 | 002 | listed patent expiry date: 2038-10-10 | drug product, U-3950 |
| Patent 10786489 | 002 | listed patent expiry date: 2038-10-10 | drug product, U-3949 |
| Patent 10786489 | 002 | listed patent expiry date: 2038-10-10 | drug product, U-3951 |
| Patent 12138250 | 001 | listed patent expiry date: 2038-10-10 | U-3949 |
| Patent 12138250 | 001 | listed patent expiry date: 2038-10-10 | U-3951 |
| Patent 12138250 | 001 | listed patent expiry date: 2038-10-10 | U-3950 |
| Patent 12138250 | 001 | listed patent expiry date: 2038-10-10 | U-3450 |
| Patent 12138250 | 002 | listed patent expiry date: 2038-10-10 | U-3951 |
| Patent 12138250 | 002 | listed patent expiry date: 2038-10-10 | U-3950 |
| Patent 12138250 | 002 | listed patent expiry date: 2038-10-10 | U-3949 |
| Patent 12138250 | 002 | listed patent expiry date: 2038-10-10 | U-3450 |
| Patent 10584124 | 001 | listed patent expiry date: 2039-04-10 | pediatric extension |
| Patent 10584124 | 002 | listed patent expiry date: 2039-04-10 | pediatric extension |
| Patent 10786489 | 001 | listed patent expiry date: 2039-04-10 | pediatric extension |
| Patent 10786489 | 002 | listed patent expiry date: 2039-04-10 | pediatric extension |
| Patent 12138250 | 001 | listed patent expiry date: 2039-04-10 | pediatric extension |
| Patent 12138250 | 002 | listed patent expiry date: 2039-04-10 | pediatric extension |
| Exclusivity ODE-301 | 001 | listed exclusivity date: 2027-05-08 | FDA code as listed |
| Exclusivity ODE-301 | 002 | listed exclusivity date: 2027-05-08 | FDA code as listed |
| Exclusivity ODE-302 | 001 | listed exclusivity date: 2027-05-08 | FDA code as listed |
| Exclusivity ODE-302 | 002 | listed exclusivity date: 2027-05-08 | FDA code as listed |
| Exclusivity ODE-303 | 001 | listed exclusivity date: 2027-05-08 | FDA code as listed |
| Exclusivity ODE-303 | 002 | listed exclusivity date: 2027-05-08 | FDA code as listed |
| Exclusivity NPP | 001 | listed exclusivity date: 2027-05-29 | FDA code as listed |
| Exclusivity NPP | 002 | listed exclusivity date: 2027-05-29 | FDA code as listed |
| Exclusivity M-311 | 001 | listed exclusivity date: 2027-09-27 | FDA code as listed |
| Exclusivity M-311 | 002 | listed exclusivity date: 2027-09-27 | FDA code as listed |
| Exclusivity M-312 | 001 | listed exclusivity date: 2027-09-27 | FDA code as listed |
| Exclusivity M-312 | 002 | listed exclusivity date: 2027-09-27 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2027-11-08 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2027-11-08 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2027-11-08 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2027-11-08 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2027-11-08 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2027-11-08 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2027-11-29 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2027-11-29 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2028-03-27 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2028-03-27 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2028-03-27 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2028-03-27 | FDA code as listed |
| Exclusivity ODE-409 | 001 | listed exclusivity date: 2029-09-21 | FDA code as listed |
| Exclusivity ODE-409 | 002 | listed exclusivity date: 2029-09-21 | FDA code as listed |
| Exclusivity ODE-412 | 001 | listed exclusivity date: 2029-09-21 | FDA code as listed |
| Exclusivity ODE-412 | 002 | listed exclusivity date: 2029-09-21 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2030-03-21 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2030-03-21 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2030-03-21 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2030-03-21 | FDA code as listed |
| Exclusivity ODE-484 | 001 | listed exclusivity date: 2031-05-29 | FDA code as listed |
| Exclusivity ODE-484 | 002 | listed exclusivity date: 2031-05-29 | FDA code as listed |
| Exclusivity ODE-485 | 001 | listed exclusivity date: 2031-05-29 | FDA code as listed |
| Exclusivity ODE-485 | 002 | listed exclusivity date: 2031-05-29 | FDA code as listed |
| Exclusivity ODE-487 | 001 | listed exclusivity date: 2031-05-29 | FDA code as listed |
| Exclusivity ODE-487 | 002 | listed exclusivity date: 2031-05-29 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2031-11-29 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2031-11-29 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2031-11-29 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2031-11-29 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2031-11-29 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2031-11-29 | FDA code as listed |
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 · FDA-approved application index
Peer clusters: Large-cap biopharma
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.