When does Verzenio go off patent?
In the US, generics can launch from 2031. Verzenio is sold by Eli Lilly. Lilly 10-K: US compound patent 2031.
Verzenio'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 small-molecule drug, so copies are generics. Generic launches usually take most of the US volume within months.
| Patent or protection | Covers | Expiry |
|---|---|---|
| US 7,855,211 | Abemaciclib itself and the drug product | 28 September 2031 |
| Europe compound patent | Verzenios | 2033 |
| Japan compound patent | Verzenio | 2034 |
| Data protection, Europe | Verzenios | 2028 |
Verzenio has a single patent listed with the FDA, on abemaciclib itself, running to 28 September 2031. Lilly reports no US generic challenge. Outside the US the compound patent runs longer, to 2033 in major European countries and 2034 in Japan. Medicare's negotiated price for Verzenio takes effect in 2028.
Sources: FDA Orange Book data files · Lilly 10-K 2025
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2021 | $1.35B | $0.83B | – |
| 2022 | $2.48B | $1.65B | +84% |
| 2023 | $3.86B | $2.51B | +56% |
| 2024 | $5.31B | $3.42B | +37% |
| 2025 | $5.72B | $3.46B | +8% |
Worldwide net sales as reported, with the US share. Sources: Lilly 10-K 2025 · Lilly 10-K 2023
No US filing found Lilly discloses no US generic challenge to Verzenio in its 2025 annual report. Its US compound patent runs to 2031.
Checked October 2026. Sources: Lilly 10-K 2025
Among past small-molecule drugs facing unrestricted generics, US sales in the first full year after copies arrived were a median 18% of the last full year before (range 0% to 48%, 10 drugs), and 6% by the third year (8 drugs). Where settlements limit generic volumes, as with Revlimid, the decline is slower. 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 2032) | Year 2 | Year 3 |
|---|---|---|---|---|
| Fastest past case | $3.46B | $0.00B0% | $0.00B0% | $0.03B1% |
| Median | $3.46B | $0.62B18% | $0.25B7% | $0.20B6% |
| Slowest past case | $3.46B | $1.66B48% | $0.86B25% | $0.60B17% |
An illustration, not a forecast: it applies the past-cliff benchmarks to Verzenio's 2025 US sales, held flat until copies arrive in 2031. Year 1 is the first full year with copies on sale.
Verzenio was selected for the Medicare Drug Price Negotiation Program. CMS must publish the negotiated prices for 2028 by 30 November 2026. That is 3 years before US generics can launch, so Medicare revenue comes under pressure first. 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 →
Verzenio is 8.8% of Eli Lilly's 2025 revenue ($5.7B of $65.2B). With Trulicity, Jardiance, Taltz, 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. Verzenio 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.
Prices are due from CMS by 30 November 2026.
Company guidance. Lilly 10-K: US compound patent 2031.