2035, date not disclosed
Ultomiris expected to lose US exclusivity
Company guidance. AstraZeneca 20-F: US patent protection expected to 2035. Rare immune and blood diseases.
When does Ultomiris go off patent?
In the US, biosimilars can launch from 2035. Ultomiris is sold by AstraZeneca. AstraZeneca 20-F: US patent protection expected to 2035. Rare immune and blood diseases.
Ultomiris's US exclusivity date is based on company guidance. The date comes from the company's own filings or guidance. Secondary patents, new formulations or litigation can still move it. It is a biologic, so copies are biosimilars. Biosimilars are harder to make and usually erode sales more gradually than generics.
| Patent or protection | Covers | Expiry |
|---|---|---|
| FDA orphan exclusivity | One approved use | 7 June 2028 |
| FDA 12-year biologic exclusivity | Counted from approval on 21 December 2018 | 21 December 2030 |
| Key US patent | Ravulizumab itself, per AstraZeneca | 2035 |
| Other US patents | Per AstraZeneca | 2038 to 2041 |
| Europe and Japan | Ravulizumab itself; other patents to 2038 to 2040 | 2035 |
AstraZeneca lists 2035 as the expiry of Ultomiris's key US patent, with other US patents running to 2041; in Europe and Japan the key patent also runs to 2035. Its 12-year US biologic exclusivity ends in December 2030. We found no biosimilar program. Its predecessor, Soliris, already faces US biosimilars.
Sources: AstraZeneca 20-F 2025 · FDA Purple Book
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2021 | $0.69B | $0.38B | – |
| 2022 | $1.97B | $1.14B | +186% |
| 2023 | $3.00B | $1.75B | +53% |
| 2024 | $3.92B | $2.26B | +31% |
| 2025 | $4.72B | $2.67B | +20% |
Worldwide net sales as reported, with the US share. Sources: AstraZeneca 20-F 2025 · AstraZeneca 20-F 2023
No US filing found We found no Ultomiris biosimilar program as of October 2026. Its predecessor Soliris already faces US biosimilars.
Checked October 2026. Sources: AstraZeneca 20-F 2025
Among past biologics facing biosimilars, US sales in the first full year after copies arrived were a median 65% of the last full year before (range 34% to 93%, 7 drugs), and 27% by the third year (9 drugs). Biosimilars usually take share more gradually than generics. Every drug is different: settlements, how many copies launch, and pricing all change the curve. See the erosion benchmarks →
Ultomiris is 8% of AstraZeneca's 2025 revenue ($4.7B of $58.7B). With Farxiga, Lynparza, Imfinzi, Tagrisso and Calquence, the drugs tracked here add up to 57% of AstraZeneca's revenue losing US exclusivity by 2035.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Ultomiris is highlighted.
Company guidance. AstraZeneca 20-F: US patent protection expected to 2035. Rare immune and blood diseases.