15 January 2030
Earliest launch for MSN's generic Cabometyx
MSN has FDA approval, but an appeals court upheld Exelixis's patents in August 2026.
When does Cabometyx go off patent?
In the US, generics can launch from 2031. Cabometyx is sold by Exelixis. 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.
| Patent or protection | Covers | Expiry |
|---|---|---|
| US 7,579,473 | Cabozantinib itself and the drug product | 14 August 2026 |
| Patents upheld against MSN | Drug substance, drug product and a use | 15 January 2030 |
| US 8,877,776 | Cabozantinib malate, the drug product and uses | 8 October 2030 |
| Teva and Cipla settlements | US licence to launch generics | 1 January 2031 |
| Later patents | Uses and drug product | 9 July 2033 |
Cabometyx's compound patent expires in August 2026, but later patents keep generics out longer. An appeals court upheld Exelixis's patents against MSN in August 2026, so MSN cannot launch before 15 January 2030 even though the FDA gave it final approval that month. Teva and Cipla settled for a US licence from 1 January 2031. Patents on the malate salt run to October 2030 and others to 2033.
Sources: FDA Orange Book data files · Exelixis 10-K 2025
| Year | Exelixis net product revenue (US) | US | Growth |
|---|---|---|---|
| 2021 | $1.08B | $1.08B | – |
| 2022 | $1.40B | $1.40B | +30% |
| 2023 | $1.63B | $1.63B | +16% |
| 2024 | $1.81B | $1.81B | +11% |
| 2025 | $2.12B | $2.12B | +17% |
Almost all Cabometyx; includes the much smaller Cometriq. Ipsen and Takeda sell Cabometyx outside the US. Net sales as reported, with the US share. Sources: Exelixis 10-K 2025 · Exelixis 10-K 2023
Approved, waiting to launch The FDA gave MSN final approval in August 2026, but an appeals court upheld Exelixis's patents that month, so MSN cannot launch before 15 January 2030. Teva and Cipla settled for a US license from 1 January 2031. Azurity and Handa filed versions in different forms.
| Company (product) | Stage |
|---|---|
| MSN | FDA-approved 14 Aug 2026; barred by court until 15 Jan 2030 |
| Teva | Filed with the FDA; settled; US entry allowed from 1 Jan 2031 |
| Cipla | Filed with the FDA; settled; US entry allowed from 1 Jan 2031 |
| Biocon | Filed with the FDA; settled Jul 2025 |
| Azurity | Different strengths: tentatively approved; in litigation |
| Handa | Capsules: tentatively approved Aug 2026 |
Checked October 2026. Sources: FDA Orange Book: MSN · Exelixis: appeal ruling, Aug 2026 · Exelixis 10-K 2025 · Fierce Pharma: Teva settlement
Among past small-molecule drugs facing unrestricted generics, US sales in the first full year after copies arrived were a median 18% of the last full year before (range 0% to 48%, 10 drugs), and 6% by the third year (8 drugs). Where settlements limit generic volumes, as with Revlimid, the decline is slower. Every drug is different: settlements, how many copies launch, and pricing all change the curve. See the erosion benchmarks →
| Scenario | 2025 US sales | Year 1 (about 2032) | Year 2 | Year 3 |
|---|---|---|---|---|
| Fastest past case | $2.12B | $0.00B0% | $0.00B0% | $0.02B1% |
| Median | $2.12B | $0.38B18% | $0.15B7% | $0.12B6% |
| Slowest past case | $2.12B | $1.02B48% | $0.53B25% | $0.37B17% |
An illustration, not a forecast: it applies the past-cliff benchmarks to Cabometyx's 2025 US sales, held flat until copies arrive in 2031. Year 1 is the first full year with copies on sale.
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.
MSN has FDA approval, but an appeals court upheld Exelixis's patents in August 2026.
Under settlements with Exelixis.