# LUMAKRAS — FDA application NDA214665

Informational only - not investment advice.

Application NDA214665 · type NDA · FDA status: approved · original approval 2021-05-28

Listed sponsor: AMGEN INC · [AMGN company profile](/company/AMGN/) · 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 | LUMAKRAS | SOTORASIB | TABLET | ORAL | 120MG | Prescription | not listed | Yes |
| 002 | LUMAKRAS | SOTORASIB | TABLET | ORAL | 320MG | Prescription | not listed | Yes |
| 003 | LUMAKRAS | SOTORASIB | TABLET | ORAL | 240MG | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 10519146, product 001; listed patent expiry date: 2038-05-21.
- Patent 10519146, product 002; listed patent expiry date: 2038-05-21.
- Patent 10519146, product 003; listed patent expiry date: 2038-05-21.
- Patent 12280056, product 001; listed patent expiry date: 2039-11-18.
- Patent 12280056, product 002; listed patent expiry date: 2039-11-18.
- Patent 12280056, product 003; listed patent expiry date: 2039-11-18.
- Patent 11236091, product 001; listed patent expiry date: 2040-05-20.
- Patent 11236091, product 001; listed patent expiry date: 2040-05-20.
- Patent 11236091, product 002; listed patent expiry date: 2040-05-20.
- Patent 11236091, product 002; listed patent expiry date: 2040-05-20.
- Patent 11236091, product 003; listed patent expiry date: 2040-05-20.
- Patent 11236091, product 003; listed patent expiry date: 2040-05-20.
- Patent 11827635, product 001; listed patent expiry date: 2040-05-20.
- Patent 11827635, product 001; listed patent expiry date: 2040-05-20.
- Patent 11827635, product 002; listed patent expiry date: 2040-05-20.
- Patent 11827635, product 002; listed patent expiry date: 2040-05-20.
- Patent 11827635, product 003; listed patent expiry date: 2040-05-20.
- Patent 11827635, product 003; listed patent expiry date: 2040-05-20.
- Patent 12398133, product 001; listed patent expiry date: 2040-05-20.
- Patent 12398133, product 001; listed patent expiry date: 2040-05-20.
- Patent 12398133, product 002; listed patent expiry date: 2040-05-20.
- Patent 12398133, product 002; listed patent expiry date: 2040-05-20.
- Patent 12398133, product 003; listed patent expiry date: 2040-05-20.
- Patent 12398133, product 003; listed patent expiry date: 2040-05-20.
- Patent 11426404, product 001; listed patent expiry date: 2040-09-15.
- Patent 11426404, product 001; listed patent expiry date: 2040-09-15.
- Patent 11426404, product 002; listed patent expiry date: 2040-09-15.
- Patent 11426404, product 002; listed patent expiry date: 2040-09-15.
- Patent 11426404, product 003; listed patent expiry date: 2040-09-15.
- Patent 11426404, product 003; listed patent expiry date: 2040-09-15.
- Exclusivity NCE, product 001; listed exclusivity date: 2026-05-28.
- Exclusivity NCE, product 002; listed exclusivity date: 2026-05-28.
- Exclusivity NCE, product 003; listed exclusivity date: 2026-05-28.
- Exclusivity I-962, product 001; listed exclusivity date: 2028-01-16.
- Exclusivity I-962, product 002; listed exclusivity date: 2028-01-16.
- Exclusivity I-962, product 003; listed exclusivity date: 2028-01-16.
- Exclusivity ODE*, product 003; listed exclusivity date: 2028-05-28.
- Exclusivity ODE-352, product 001; listed exclusivity date: 2028-05-28.
- Exclusivity ODE-352, product 002; listed exclusivity date: 2028-05-28.
- Exclusivity ODE-507, product 001; listed exclusivity date: 2032-01-16.
- Exclusivity ODE-507, product 002; listed exclusivity date: 2032-01-16.
- Exclusivity ODE-507, product 003; listed exclusivity date: 2032-01-16.

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

- SOTORASIB · UNII 2B2VM6UC8G · [lmmol compound NXQKSXLFSAEQCZ-SFHVURJKSA-N](https://lmmol.com/compound/NXQKSXLFSAEQCZ-SFHVURJKSA-N)

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/AMGN/)
- [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:NDA214665. FDA data retrieved 2026-08-07.

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