2037, date not disclosed
Trikafta expected to lose US exclusivity
Patent-expiry estimate. Patents run to about 2037. Cystic fibrosis. Excludes the successor Alyftrek ($0.8B).
When does Trikafta go off patent?
In the US, generics can launch from 2037. Trikafta is sold by Vertex. Patents run to about 2037. Cystic fibrosis. Excludes the successor Alyftrek ($0.8B).
Trikafta's US exclusivity date is based on patent-expiry estimate. It is estimated from patent expiry rather than a fixed entry date, so it may move as patents are challenged or extended. 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 basic product patent (Vertex) | Trikafta | 2037 |
| Latest drug-substance patents listed with the FDA | The active ingredients and the drug product | 8 December 2037 |
| Last listed patent | One listed patent | 17 July 2038 |
| FDA orphan exclusivities | Uses in younger children | 27 March 2033 |
Vertex lists 2037 as the expiry of Trikafta's basic product patent in both the US and Europe. The FDA lists 35 patents for Trikafta, the latest running to July 2038. Vertex's 2025 annual report discloses no generic challenge. Vertex is also moving patients to Alyftrek, its newer cystic fibrosis medicine, whose basic patent runs to 2039.
Sources: FDA Orange Book data files · Vertex 10-K 2025
| Year | Trikafta/Kaftrio, worldwide | Growth |
|---|---|---|
| 2023 | $8.95B | – |
| 2024 | $10.24B | +14% |
| 2025 | $10.31B | +1% |
Net sales as reported. Source: Vertex 10-K 2025
No US filing found Vertex discloses no US generic challenge to Trikafta in its 2025 annual report. Its patents are estimated to run to about 2037.
Checked October 2026. Sources: Vertex 10-K 2025
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 →
Trikafta is 86% of Vertex's 2025 revenue ($10.3B of $12.0B).
Bars show each company's tracked drugs as a share of its total 2025 revenue. Trikafta is highlighted.
Patent-expiry estimate. Patents run to about 2037. Cystic fibrosis. Excludes the successor Alyftrek ($0.8B).