# CABOMETYX — FDA application NDA208692

Informational only - not investment advice.

Application NDA208692 · type NDA · FDA status: approved · original approval 2016-04-25

Listed sponsor: EXELIXIS INC · [EXEL company profile](/company/EXEL/) · 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 |

## Orange Book patent and exclusivity listings

- Patent 7579473, product 001; listed patent expiry date: 2026-08-14.
- Patent 7579473, product 002; listed patent expiry date: 2026-08-14.
- Patent 7579473, product 003; listed patent expiry date: 2026-08-14.
- Patent 11091439, product 001; listed patent expiry date: 2030-01-15.
- Patent 11091439, product 002; listed patent expiry date: 2030-01-15.
- Patent 11091439, product 003; listed patent expiry date: 2030-01-15.
- Patent 11091440, product 001; listed patent expiry date: 2030-01-15.
- Patent 11091440, product 002; listed patent expiry date: 2030-01-15.
- Patent 11091440, product 003; listed patent expiry date: 2030-01-15.
- Patent 11098015, product 001; listed patent expiry date: 2030-01-15.
- Patent 11098015, product 001; listed patent expiry date: 2030-01-15.
- Patent 11098015, product 001; listed patent expiry date: 2030-01-15.
- Patent 11098015, product 001; listed patent expiry date: 2030-01-15.
- Patent 11098015, product 001; listed patent expiry date: 2030-01-15.
- Patent 11098015, product 001; listed patent expiry date: 2030-01-15.
- Patent 11098015, product 002; listed patent expiry date: 2030-01-15.
- Patent 11098015, product 002; listed patent expiry date: 2030-01-15.
- Patent 11098015, product 002; listed patent expiry date: 2030-01-15.
- Patent 11098015, product 002; listed patent expiry date: 2030-01-15.
- Patent 11098015, product 002; listed patent expiry date: 2030-01-15.
- Patent 11098015, product 002; listed patent expiry date: 2030-01-15.
- Patent 11098015, product 003; listed patent expiry date: 2030-01-15.
- Patent 11098015, product 003; listed patent expiry date: 2030-01-15.
- Patent 11098015, product 003; listed patent expiry date: 2030-01-15.
- Patent 11098015, product 003; listed patent expiry date: 2030-01-15.
- Patent 11098015, product 003; listed patent expiry date: 2030-01-15.
- Patent 11098015, product 003; listed patent expiry date: 2030-01-15.
- Patent 8877776, product 001; listed patent expiry date: 2030-10-08.
- Patent 8877776, product 002; listed patent expiry date: 2030-10-08.
- Patent 8877776, product 003; listed patent expiry date: 2030-10-08.
- Patent 10034873, product 001; listed patent expiry date: 2031-07-18.
- Patent 10034873, product 002; listed patent expiry date: 2031-07-18.
- Patent 10034873, product 003; listed patent expiry date: 2031-07-18.
- Patent 10039757, product 001; listed patent expiry date: 2031-07-18.
- Patent 10039757, product 002; listed patent expiry date: 2031-07-18.
- Patent 10039757, product 003; listed patent expiry date: 2031-07-18.
- Patent 11298349, product 001; listed patent expiry date: 2032-02-10.
- Patent 11298349, product 002; listed patent expiry date: 2032-02-10.
- Patent 11298349, product 003; listed patent expiry date: 2032-02-10.
- Patent 12128039, product 001; listed patent expiry date: 2032-02-10.
- Patent 12128039, product 001; listed patent expiry date: 2032-02-10.
- Patent 12128039, product 001; listed patent expiry date: 2032-02-10.
- Patent 12128039, product 001; listed patent expiry date: 2032-02-10.
- Patent 12128039, product 001; listed patent expiry date: 2032-02-10.
- Patent 12128039, product 001; listed patent expiry date: 2032-02-10.
- Patent 12128039, product 002; listed patent expiry date: 2032-02-10.
- Patent 12128039, product 002; listed patent expiry date: 2032-02-10.
- Patent 12128039, product 002; listed patent expiry date: 2032-02-10.
- Patent 12128039, product 002; listed patent expiry date: 2032-02-10.
- Patent 12128039, product 002; listed patent expiry date: 2032-02-10.
- Patent 12128039, product 002; listed patent expiry date: 2032-02-10.
- Patent 12128039, product 003; listed patent expiry date: 2032-02-10.
- Patent 12128039, product 003; listed patent expiry date: 2032-02-10.
- Patent 12128039, product 003; listed patent expiry date: 2032-02-10.
- Patent 12128039, product 003; listed patent expiry date: 2032-02-10.
- Patent 12128039, product 003; listed patent expiry date: 2032-02-10.
- Patent 12128039, product 003; listed patent expiry date: 2032-02-10.
- Patent 9724342, product 001; listed patent expiry date: 2033-07-09.
- Patent 9724342, product 002; listed patent expiry date: 2033-07-09.
- Patent 9724342, product 003; listed patent expiry date: 2033-07-09.
- Exclusivity ODE-227, product 001; listed exclusivity date: 2026-01-14.
- Exclusivity ODE-227, product 002; listed exclusivity date: 2026-01-14.
- Exclusivity ODE-227, product 003; listed exclusivity date: 2026-01-14.
- Exclusivity ODE-375, product 001; listed exclusivity date: 2028-09-17.
- Exclusivity ODE-375, product 002; listed exclusivity date: 2028-09-17.
- Exclusivity ODE-375, product 003; listed exclusivity date: 2028-09-17.
- Exclusivity ODE-530, product 001; listed exclusivity date: 2032-03-26.
- Exclusivity ODE-530, product 002; listed exclusivity date: 2032-03-26.
- Exclusivity ODE-530, product 003; listed exclusivity date: 2032-03-26.

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](https://lmmol.com/compound/HFCFMRYTXDINDK-WNQIDUERSA-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/EXEL/)
- [FDA-approved application index](/drug/)

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:NDA208692. FDA data retrieved 2026-08-07.

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