LUMAKRAS — FDA application NDA214665
Listed sponsor: AMGEN INC · AMGN 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 | 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 |
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 10519146 | 001 | listed patent expiry date: 2038-05-21 | drug substance, drug product |
| Patent 10519146 | 002 | listed patent expiry date: 2038-05-21 | drug substance, drug product |
| Patent 10519146 | 003 | listed patent expiry date: 2038-05-21 | drug substance, drug product |
| Patent 12280056 | 001 | listed patent expiry date: 2039-11-18 | U-4107 |
| Patent 12280056 | 002 | listed patent expiry date: 2039-11-18 | U-4107 |
| Patent 12280056 | 003 | listed patent expiry date: 2039-11-18 | U-4107 |
| Patent 11236091 | 001 | listed patent expiry date: 2040-05-20 | drug substance, drug product, U-4107 |
| Patent 11236091 | 001 | listed patent expiry date: 2040-05-20 | drug substance, drug product, U-3306 |
| Patent 11236091 | 002 | listed patent expiry date: 2040-05-20 | drug substance, drug product, U-3306 |
| Patent 11236091 | 002 | listed patent expiry date: 2040-05-20 | drug substance, drug product, U-4107 |
| Patent 11236091 | 003 | listed patent expiry date: 2040-05-20 | drug substance, drug product, U-4107 |
| Patent 11236091 | 003 | listed patent expiry date: 2040-05-20 | drug substance, drug product, U-3306 |
| Patent 11827635 | 001 | listed patent expiry date: 2040-05-20 | drug substance, drug product, U-4107 |
| Patent 11827635 | 001 | listed patent expiry date: 2040-05-20 | drug substance, drug product, U-3306 |
| Patent 11827635 | 002 | listed patent expiry date: 2040-05-20 | drug substance, drug product, U-4107 |
| Patent 11827635 | 002 | listed patent expiry date: 2040-05-20 | drug substance, drug product, U-3306 |
| Patent 11827635 | 003 | listed patent expiry date: 2040-05-20 | drug substance, drug product, U-4107 |
| Patent 11827635 | 003 | listed patent expiry date: 2040-05-20 | drug substance, drug product, U-3306 |
| Patent 12398133 | 001 | listed patent expiry date: 2040-05-20 | drug substance, drug product, U-3306 |
| Patent 12398133 | 001 | listed patent expiry date: 2040-05-20 | drug substance, drug product, U-4107 |
| Patent 12398133 | 002 | listed patent expiry date: 2040-05-20 | drug substance, drug product, U-4107 |
| Patent 12398133 | 002 | listed patent expiry date: 2040-05-20 | drug substance, drug product, U-3306 |
| Patent 12398133 | 003 | listed patent expiry date: 2040-05-20 | drug substance, drug product, U-4107 |
| Patent 12398133 | 003 | listed patent expiry date: 2040-05-20 | drug substance, drug product, U-3306 |
| Patent 11426404 | 001 | listed patent expiry date: 2040-09-15 | U-3306 |
| Patent 11426404 | 001 | listed patent expiry date: 2040-09-15 | U-4107 |
| Patent 11426404 | 002 | listed patent expiry date: 2040-09-15 | U-3306 |
| Patent 11426404 | 002 | listed patent expiry date: 2040-09-15 | U-4107 |
| Patent 11426404 | 003 | listed patent expiry date: 2040-09-15 | U-4107 |
| Patent 11426404 | 003 | listed patent expiry date: 2040-09-15 | U-3306 |
| Exclusivity NCE | 001 | listed exclusivity date: 2026-05-28 | FDA code as listed |
| Exclusivity NCE | 002 | listed exclusivity date: 2026-05-28 | FDA code as listed |
| Exclusivity NCE | 003 | listed exclusivity date: 2026-05-28 | FDA code as listed |
| Exclusivity I-962 | 001 | listed exclusivity date: 2028-01-16 | FDA code as listed |
| Exclusivity I-962 | 002 | listed exclusivity date: 2028-01-16 | FDA code as listed |
| Exclusivity I-962 | 003 | listed exclusivity date: 2028-01-16 | FDA code as listed |
| Exclusivity ODE* | 003 | listed exclusivity date: 2028-05-28 | FDA code as listed |
| Exclusivity ODE-352 | 001 | listed exclusivity date: 2028-05-28 | FDA code as listed |
| Exclusivity ODE-352 | 002 | listed exclusivity date: 2028-05-28 | FDA code as listed |
| Exclusivity ODE-507 | 001 | listed exclusivity date: 2032-01-16 | FDA code as listed |
| Exclusivity ODE-507 | 002 | listed exclusivity date: 2032-01-16 | FDA code as listed |
| Exclusivity ODE-507 | 003 | listed exclusivity date: 2032-01-16 | 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
- SOTORASIB · UNII 2B2VM6UC8G · lmmol compound NXQKSXLFSAEQCZ-SFHVURJKSA-N · CHEMBL4535757
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.