Generic competition · all medicines · read 12 November 2026
Is there a generic of Cabozantinib S-Malate, and who makes it?
Cabozantinib S-Malate appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 1 generic maker listed as marketed across them. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came 10.3 years after the first brand approval. This is the Orange Book's listing, not a forecast.
Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.
- Cabozantinib S-Malate appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 1 generic maker listed as marketed across them.
- 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
- Where both are dated, the first generic approval came 10.3 years after the first brand approval.
- Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.
Tablet, Oral
One to three generic makers listed
Brand listed as marketed: Cabometyx. 1 generic maker with 3 generic products listed as marketed; the first generic approval is dated 14 August 2026.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Msn Laboratories Private Ltd | 14 August 2026 | 3 |
Patents and exclusivities still listed
- 17 September 2028Exclusivity ODE-375 Cabometyx
- 26 March 2032Exclusivity ODE-530 Cabometyx
- 15 January 2030Patent 11098015
- 15 January 2030Patent 11091440 drug product
- 15 January 2030Patent 11091439 drug substance
- 8 October 2030Patent 8877776 drug substance
- 18 July 2031Patent 10039757
- 18 July 2031Patent 10034873
- 10 February 2032Patent 12128039 drug product
- 10 February 2032Patent 11298349 drug product
1 more patents are listed.
Capsule, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Cometriq. No generic is listed as marketed.
Patents and exclusivities still listed
- 15 January 2030Patent 11098015
- 15 January 2030Patent 11091440 drug product
- 15 January 2030Patent 11091439 drug substance
- 8 October 2030Patent 8877776 drug substance
- 10 February 2032Patent 12128039 drug product
- 10 February 2032Patent 11298349 drug product
- 10 February 2032Patent 9717720 drug product
US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.
Where can you go from this result?
Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.