2030, date not disclosed
Taltz expected to lose US exclusivity
Company guidance. Lilly 10-K: US compound patent 2030; US biologics data protection runs to 2028.
When does Taltz go off patent?
In the US, biosimilars can launch from 2030. Taltz is sold by Eli Lilly. Lilly 10-K: US compound patent 2030; US biologics data protection runs to 2028.
Taltz'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 biologic data protection | Counted from approval on 22 March 2016 | 22 March 2028 |
| US compound patent | Ixekizumab, per Lilly | 2030 |
| Europe compound patent | Taltz, per Lilly | 2031 |
| Japan compound patent | Taltz, per Lilly | 2030 |
Lilly says Taltz's US compound patent runs to 2030, after its 12-year US biologic data protection ends in 2028; the compound patent runs to 2031 in major European countries and 2030 in Japan. Biosimilars are at an early stage: Samsung Bioepis started a first trial in August 2026, and Celltrion and Alvotech have announced programs.
Sources: Lilly 10-K 2025 · FDA Purple Book
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2021 | $2.21B | $1.54B | – |
| 2022 | $2.48B | $1.73B | +12% |
| 2023 | $2.76B | $1.83B | +11% |
| 2024 | $3.26B | $2.15B | +18% |
| 2025 | $3.56B | $2.33B | +9% |
Worldwide net sales as reported, with the US share. Sources: Lilly 10-K 2025 · Lilly 10-K 2023
In clinical trials Samsung Bioepis started a first trial of its Taltz biosimilar in August 2026. Celltrion and Alvotech have also announced programs.
| Company (product) | Stage |
|---|---|
| Samsung Bioepis (SB35) | In clinical trials. Phase 1 started Aug 2026 |
| Celltrion (CT-P52) | Early development |
| Alvotech (AVT28) | Early development |
Checked October 2026. Sources: Pearce IP: Samsung Bioepis trial · BioPatrika: Taltz biosimilars
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 →
| Scenario | 2025 US sales | Year 1 (about 2031) | Year 2 | Year 3 |
|---|---|---|---|---|
| Fastest past case | $2.33B | $0.79B34% | $0.25B11% | $0.10B4% |
| Median | $2.33B | $1.52B65% | $0.89B38% | $0.62B27% |
| Slowest past case | $2.33B | $2.18B93% | $1.77B76% | $1.48B64% |
An illustration, not a forecast: it applies the past-cliff benchmarks to Taltz's 2025 US sales, held flat until copies arrive in 2030. Year 1 is the first full year with copies on sale.
Taltz is 5.5% of Eli Lilly's 2025 revenue ($3.6B of $65.2B). With Trulicity, Jardiance, Verzenio, Mounjaro and Zepbound, the drugs tracked here add up to 82% of Eli Lilly's revenue losing US exclusivity by 2036.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Taltz is highlighted.
Company guidance. Lilly 10-K: US compound patent 2030; US biologics data protection runs to 2028.