Cabometyx (Exelixis) is expected to face US generic competition from 2031. Settlements with Teva and Cipla allow US generics from 1 January 2031; a court upheld other patents against MSN. US sales, recorded by Exelixis.
Cabometyx's US exclusivity date is based on settlement / court date. Litigation settlements or a court ruling fix the earliest US entry date, which makes it one of the firmer dates in this tracker. It is a small-molecule drug, so copies are generics. Generic launches usually take most of the US volume within months.
Among past small-molecule drugs facing generics: Tecfidera's US sales fell to 21% of their 2019 level in its first full year of generics (2021); Revlimid's US sales fell to 96% of their 2021 level in its first full year of generics (2022) and 57% two years later. Where settlements cap generic volumes, as with Revlimid, the decline is slower. See how past cliffs played out →
Tentatively approved Teva and Cipla settled for a US license from 1 January 2031. MSN holds a tentative approval but lost a 2023 trial over patents expiring in January 2030. Azurity and Handa filed versions in different strengths.
| Company (product) | Stage |
|---|---|
| Teva | Settled; license from 1 Jan 2031 |
| Cipla | Settled; license from 1 Jan 2031 |
| Biocon | Settled Jul 2025 |
| MSN | Tentative approval; lost patent trial (2023) |
| Azurity | Tentative approval (different strengths); sued |
| Handa | Application filed (capsules) |
Checked September 2026. Sources: Exelixis 10-K 2025 · Fierce Pharma: Teva settlement
Cabometyx is 91% of Exelixis's 2025 revenue ($2.1B of $2.3B).
Bars show each company's tracked drugs as a share of its total 2025 revenue. Cabometyx is highlighted.