CABOMETYX — FDA application NDA208692
Listed sponsor: EXELIXIS INC · EXEL 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 | CABOMETYX | CABOZANTINIB S-MALATE | TABLET | ORAL | EQ 20MG BASE | Prescription | not listed | Yes |
| 002 | CABOMETYX | CABOZANTINIB S-MALATE | TABLET | ORAL | EQ 40MG BASE | Prescription | not listed | Yes |
| 003 | CABOMETYX | CABOZANTINIB S-MALATE | TABLET | ORAL | EQ 60MG BASE | 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 7579473 | 001 | listed patent expiry date: 2026-08-14 | drug substance, drug product |
| Patent 7579473 | 002 | listed patent expiry date: 2026-08-14 | drug substance, drug product |
| Patent 7579473 | 003 | listed patent expiry date: 2026-08-14 | drug substance, drug product |
| Patent 11091439 | 001 | listed patent expiry date: 2030-01-15 | drug substance |
| Patent 11091439 | 002 | listed patent expiry date: 2030-01-15 | drug substance |
| Patent 11091439 | 003 | listed patent expiry date: 2030-01-15 | drug substance |
| Patent 11091440 | 001 | listed patent expiry date: 2030-01-15 | drug product |
| Patent 11091440 | 002 | listed patent expiry date: 2030-01-15 | drug product |
| Patent 11091440 | 003 | listed patent expiry date: 2030-01-15 | drug product |
| Patent 11098015 | 001 | listed patent expiry date: 2030-01-15 | U-4131 |
| Patent 11098015 | 001 | listed patent expiry date: 2030-01-15 | U-4156 |
| Patent 11098015 | 001 | listed patent expiry date: 2030-01-15 | U-2488 |
| Patent 11098015 | 001 | listed patent expiry date: 2030-01-15 | U-1220 |
| Patent 11098015 | 001 | listed patent expiry date: 2030-01-15 | U-1480 |
| Patent 11098015 | 001 | listed patent expiry date: 2030-01-15 | U-3225 |
| Patent 11098015 | 002 | listed patent expiry date: 2030-01-15 | U-4156 |
| Patent 11098015 | 002 | listed patent expiry date: 2030-01-15 | U-4131 |
| Patent 11098015 | 002 | listed patent expiry date: 2030-01-15 | U-2488 |
| Patent 11098015 | 002 | listed patent expiry date: 2030-01-15 | U-1220 |
| Patent 11098015 | 002 | listed patent expiry date: 2030-01-15 | U-1480 |
| Patent 11098015 | 002 | listed patent expiry date: 2030-01-15 | U-3225 |
| Patent 11098015 | 003 | listed patent expiry date: 2030-01-15 | U-4156 |
| Patent 11098015 | 003 | listed patent expiry date: 2030-01-15 | U-4131 |
| Patent 11098015 | 003 | listed patent expiry date: 2030-01-15 | U-2488 |
| Patent 11098015 | 003 | listed patent expiry date: 2030-01-15 | U-1220 |
| Patent 11098015 | 003 | listed patent expiry date: 2030-01-15 | U-1480 |
| Patent 11098015 | 003 | listed patent expiry date: 2030-01-15 | U-3225 |
| Patent 8877776 | 001 | listed patent expiry date: 2030-10-08 | drug substance, drug product, U-3225 |
| Patent 8877776 | 002 | listed patent expiry date: 2030-10-08 | drug substance, drug product, U-3225 |
| Patent 8877776 | 003 | listed patent expiry date: 2030-10-08 | drug substance, drug product, U-3225 |
| Patent 10034873 | 001 | listed patent expiry date: 2031-07-18 | U-2488 |
| Patent 10034873 | 002 | listed patent expiry date: 2031-07-18 | U-2488 |
| Patent 10034873 | 003 | listed patent expiry date: 2031-07-18 | U-2488 |
| Patent 10039757 | 001 | listed patent expiry date: 2031-07-18 | U-1480 |
| Patent 10039757 | 002 | listed patent expiry date: 2031-07-18 | U-1480 |
| Patent 10039757 | 003 | listed patent expiry date: 2031-07-18 | U-1480 |
| Patent 11298349 | 001 | listed patent expiry date: 2032-02-10 | drug product |
| Patent 11298349 | 002 | listed patent expiry date: 2032-02-10 | drug product |
| Patent 11298349 | 003 | listed patent expiry date: 2032-02-10 | drug product |
| Patent 12128039 | 001 | listed patent expiry date: 2032-02-10 | drug product, U-1220 |
| Patent 12128039 | 001 | listed patent expiry date: 2032-02-10 | drug product, U-1480 |
| Patent 12128039 | 001 | listed patent expiry date: 2032-02-10 | drug product, U-2488 |
| Patent 12128039 | 001 | listed patent expiry date: 2032-02-10 | drug product, U-3225 |
| Patent 12128039 | 001 | listed patent expiry date: 2032-02-10 | drug product, U-4131 |
| Patent 12128039 | 001 | listed patent expiry date: 2032-02-10 | drug product, U-4156 |
| Patent 12128039 | 002 | listed patent expiry date: 2032-02-10 | drug product, U-1220 |
| Patent 12128039 | 002 | listed patent expiry date: 2032-02-10 | drug product, U-1480 |
| Patent 12128039 | 002 | listed patent expiry date: 2032-02-10 | drug product, U-2488 |
| Patent 12128039 | 002 | listed patent expiry date: 2032-02-10 | drug product, U-3225 |
| Patent 12128039 | 002 | listed patent expiry date: 2032-02-10 | drug product, U-4156 |
| Patent 12128039 | 002 | listed patent expiry date: 2032-02-10 | drug product, U-4131 |
| Patent 12128039 | 003 | listed patent expiry date: 2032-02-10 | drug product, U-1220 |
| Patent 12128039 | 003 | listed patent expiry date: 2032-02-10 | drug product, U-1480 |
| Patent 12128039 | 003 | listed patent expiry date: 2032-02-10 | drug product, U-2488 |
| Patent 12128039 | 003 | listed patent expiry date: 2032-02-10 | drug product, U-3225 |
| Patent 12128039 | 003 | listed patent expiry date: 2032-02-10 | drug product, U-4156 |
| Patent 12128039 | 003 | listed patent expiry date: 2032-02-10 | drug product, U-4131 |
| Patent 9724342 | 001 | listed patent expiry date: 2033-07-09 | drug product |
| Patent 9724342 | 002 | listed patent expiry date: 2033-07-09 | drug product |
| Patent 9724342 | 003 | listed patent expiry date: 2033-07-09 | drug product |
| Exclusivity ODE-227 | 001 | listed exclusivity date: 2026-01-14 | FDA code as listed |
| Exclusivity ODE-227 | 002 | listed exclusivity date: 2026-01-14 | FDA code as listed |
| Exclusivity ODE-227 | 003 | listed exclusivity date: 2026-01-14 | FDA code as listed |
| Exclusivity ODE-375 | 001 | listed exclusivity date: 2028-09-17 | FDA code as listed |
| Exclusivity ODE-375 | 002 | listed exclusivity date: 2028-09-17 | FDA code as listed |
| Exclusivity ODE-375 | 003 | listed exclusivity date: 2028-09-17 | FDA code as listed |
| Exclusivity ODE-530 | 001 | listed exclusivity date: 2032-03-26 | FDA code as listed |
| Exclusivity ODE-530 | 002 | listed exclusivity date: 2032-03-26 | FDA code as listed |
| Exclusivity ODE-530 | 003 | listed exclusivity date: 2032-03-26 | 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
- CABOZANTINIB S-MALATE · UNII DR7ST46X58 · lmmol compound HFCFMRYTXDINDK-WNQIDUERSA-N · CHEMBL2103868
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: No published peer-cluster link for this sponsor.
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.