When does Trulicity go off patent?
In the US, biosimilars can launch from 2027. Trulicity is sold by Eli Lilly. Lilly 10-K: US compound patent and data protection end 2027.
Trulicity'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 compound patent | Dulaglutide, per Lilly | 2027 |
| US biologic data protection | Per Lilly | 2027 |
| Europe and Japan compound patents | Trulicity, per Lilly | 2029 |
Lilly says both Trulicity's US compound patent and its US data protection end in 2027, with the compound patent running to 2029 in major European countries and Japan. We found no US biosimilar filing; Boan Biotech got FDA clearance in August 2024 to start a first US trial. Sales have fallen every year since 2022, and Medicare's negotiated price takes effect in 2028.
Sources: Lilly 10-K 2025
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2021 | $6.47B | $4.91B | – |
| 2022 | $7.44B | $5.69B | +15% |
| 2023 | $7.13B | $5.43B | -4% |
| 2024 | $5.25B | $3.69B | -26% |
| 2025 | $4.28B | $2.91B | -19% |
Worldwide net sales as reported, with the US share. Sources: Lilly 10-K 2025 · Lilly 10-K 2023
Early development We found no US biosimilar filing as of October 2026. Boan Biotech received FDA clearance in August 2024 to start a first US trial of its biosimilar. Lilly guides to US compound patent and data protection ending in 2027.
| Company (product) | Stage |
|---|---|
| Boan Biotech (BA5101) | Early development. US trial cleared by FDA, Aug 2024 |
Checked October 2026. Sources: Boan Biotech: FDA trial clearance · Lilly 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 →
| Scenario | 2025 US sales | Year 1 (about 2028) | Year 2 | Year 3 |
|---|---|---|---|---|
| Fastest past case | $2.91B | $0.99B34% | $0.31B11% | $0.12B4% |
| Median | $2.91B | $1.90B65% | $1.12B38% | $0.77B27% |
| Slowest past case | $2.91B | $2.72B93% | $2.21B76% | $1.85B64% |
An illustration, not a forecast: it applies the past-cliff benchmarks to Trulicity's 2025 US sales, held flat until copies arrive in 2027. Year 1 is the first full year with copies on sale.
Trulicity was selected for the Medicare Drug Price Negotiation Program. CMS must publish the negotiated prices for 2028 by 30 November 2026. US biosimilars are due by then. For the 25 drugs negotiated so far, Medicare prices came in 38% to 85% below list price. Those discounts are measured before the rebates drugmakers already pay and apply to Medicare only. See every negotiated Medicare price →
Trulicity is 6.6% of Eli Lilly's 2025 revenue ($4.3B of $65.2B). With Jardiance, Taltz, 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. Trulicity is highlighted.
Deadline for CMS to publish the negotiated prices for the drugs selected for 2028. The prices take effect on 1 January 2028. Xeljanz will have none, because CMS found a generic on sale.
Company guidance. Lilly 10-K: US compound patent and data protection end 2027.
Prices are due from CMS by 30 November 2026.