2027, date not disclosed
Trelegy expected to lose US exclusivity
Patent-expiry estimate. GSK's latest US compound patent expires in 2027, but inhaler and formulation patents run to 2030 (2031 with pediatric exclusivity). Sales GBP 2,986M.
When does Trelegy go off patent?
In the US, generics can launch from 2027. Trelegy is sold by GSK. GSK's latest US compound patent expires in 2027, but inhaler and formulation patents run to 2030 (2031 with pediatric exclusivity). Sales GBP 2,986M.
Trelegy'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-expiry estimate. GSK's latest US compound patent expires in 2027, but inhaler and formulation patents run to 2030 (2031 with pediatric exclusivity). Sales GBP 2,986M.
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 →
No US filing found No generic application for Trelegy is listed with the FDA. Its inhaler and formulation patents run to 2030, or 2031 with pediatric exclusivity.
Checked October 2026. Sources: FDA Orange Book: Trelegy patents
Trelegy was selected for the Medicare Drug Price Negotiation Program. Its negotiated Medicare price takes effect in 2027, 73% below its list price. That is the same year US generics can launch. The discount is measured against list price, before the rebates drugmakers already pay, and applies to Medicare only, so the revenue impact is smaller than the headline number.
Trelegy is 9.1% of GSK's 2025 revenue (≈$3.9B of $43.1B). With Shingrix and Nucala, the drugs tracked here add up to 26% of GSK's revenue losing US exclusivity by 2029. Turnover GBP 32.7B.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Trelegy is highlighted.