When does Nucala go off patent?
In the US, biosimilars can launch from 2029. Nucala is sold by GSK. GSK's 20-F lists the latest US molecule patent to 2029, with other patents to 2036. The 12-year US biologic exclusivity ends in November 2027. Sales GBP 2.01B, up 15% at constant currency.
Nucala'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 biologic, so copies are biosimilars. Biosimilars are harder to make and usually erode sales more gradually than generics.
In clinical trials Bio-Thera's BAT2606 has been tested in Phase 1 against US and EU Nucala, and the company plans a global Phase 3 next. We found no other US program.
| Company (product) | Stage |
|---|---|
| Bio-Thera (BAT2606) | Phase 1; Phase 3 planned |
Checked October 2026. Sources: Bio-Thera via BioSpace
Patent-expiry estimate. GSK's 20-F lists the latest US molecule patent to 2029, with other patents to 2036. The 12-year US biologic exclusivity ends in November 2027. Sales GBP 2.01B, up 15% at constant currency.
Among past biologics facing biosimilars: Humira's US sales fell to 65% of their 2022 level in its first full year of biosimilars (2023) and 16% two years later; Stelara's US sales fell to 57% of their 2024 level in its first full year of biosimilars (2025). See how past cliffs played out →
Nucala is 6.1% of GSK's 2025 revenue (≈$2.6B of $43.1B). With Trelegy and Shingrix, 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. Nucala is highlighted.