# COMETRIQ — FDA application NDA203756

Informational only - not investment advice.

Application NDA203756 · type NDA · FDA status: approved · original approval 2012-11-29

Listed sponsor: EXELIXIS · [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 | COMETRIQ | CABOZANTINIB S-MALATE | CAPSULE | ORAL | EQ 20MG BASE | Prescription | not listed | Yes |
| 002 | COMETRIQ | CABOZANTINIB S-MALATE | CAPSULE | ORAL | EQ 80MG 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 11091439, product 001; listed patent expiry date: 2030-01-15.
- Patent 11091439, product 002; 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 11098015, product 001; listed patent expiry date: 2030-01-15.
- Patent 11098015, product 002; 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 11298349, product 001; listed patent expiry date: 2032-02-10.
- Patent 11298349, product 002; 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 9717720, product 001; listed patent expiry date: 2032-02-10.
- Patent 9717720, product 002; listed patent expiry date: 2032-02-10.

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:NDA203756. FDA data retrieved 2026-08-07.

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