2033, date not disclosed
Skyrizi expected to lose US exclusivity
Company guidance. AbbVie 10-K: US composition-of-matter patents expire 2033.
When does Skyrizi go off patent?
In the US, biosimilars can launch from 2033. Skyrizi is sold by AbbVie. AbbVie 10-K: US composition-of-matter patents expire 2033.
Skyrizi'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 |
|---|---|---|
| US composition-of-matter patents | Risankizumab itself | 2033 |
| FDA 12-year biologic exclusivity | Counted from first approval on 23 April 2019 | 23 April 2031 |
AbbVie expects the US composition-of-matter patents covering risankizumab to expire in 2033. The 12-year US exclusivity that keeps biosimilar applications from being approved runs out earlier, in April 2031, so the patents set the likely date. We found no US biosimilar program as of October 2026.
Sources: AbbVie 10-K 2025 · FDA Purple Book
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2023 | $7.76B | $6.75B | – |
| 2024 | $11.72B | $10.09B | +51% |
| 2025 | $17.56B | $15.20B | +50% |
Worldwide net sales as reported, with the US share. Source: AbbVie 10-K 2025
No US filing found We found no announced Skyrizi biosimilar program in the US as of October 2026. AbbVie's US compound patents run to 2033.
Checked October 2026. Sources: AbbVie 10-K 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 →
Skyrizi is 29% of AbbVie's 2025 revenue ($17.6B of $61.2B). With Vraylar, Imbruvica, Venclexta and Rinvoq, the drugs tracked here add up to 57% of AbbVie's revenue losing US exclusivity by 2037.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Skyrizi is highlighted.
Company guidance. AbbVie 10-K: US composition-of-matter patents expire 2033.