When does Kisqali go off patent?
In the US, generics can launch from 2031. Kisqali is sold by Novartis. Novartis 20-F: US compound patent 2031. Sales grew 58% in 2025.
Kisqali'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 8,415,355 | Ribociclib itself, with pediatric exclusivity | 13 September 2031 |
| US 9,193,732 | Ribociclib salts, with pediatric exclusivity | 9 May 2032 |
| Tablet patents | Kisqali tablets, with pediatric exclusivity | 14 October 2036 |
| Europe compound patent | Kisqali | 2032 |
Novartis gives 2031 as the US expiry of Kisqali's compound patent: 13 March 2031, or September 2031 with pediatric exclusivity. A patent on ribociclib's salt form runs to May 2032 and tablet patents to October 2036, both with pediatric exclusivity. Novartis reports no US generic challenge so far. In Europe the compound patent runs to 2032. Medicare's negotiated price for Kisqali takes effect in 2028.
Sources: FDA Orange Book data files · Novartis 20-F 2025
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2021 | $0.94B | – | – |
| 2022 | $1.23B | $0.47B | +31% |
| 2023 | $2.08B | $1.03B | +69% |
| 2024 | $3.03B | $1.68B | +46% |
| 2025 | $4.78B | $2.98B | +58% |
Novartis did not report a US figure for 2021. Worldwide net sales as reported, with the US share. Sources: Novartis 20-F 2025 · Novartis 20-F 2023 · Novartis 20-F 2022
No US filing found Novartis discloses no US generic challenge to Kisqali in its 2025 annual report. Its US compound patent runs to 2031.
Checked October 2026. Sources: Novartis 20-F 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 | $2.98B | $0.00B0% | $0.00B0% | $0.02B1% |
| Median | $2.98B | $0.53B18% | $0.21B7% | $0.17B6% |
| Slowest past case | $2.98B | $1.43B48% | $0.74B25% | $0.52B17% |
An illustration, not a forecast: it applies the past-cliff benchmarks to Kisqali's 2025 US sales, held flat until copies arrive in 2031. Year 1 is the first full year with copies on sale.
Kisqali 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 →
Kisqali is 8.8% of Novartis's 2025 revenue ($4.8B of $54.5B). With Entresto, Xolair, Cosentyx and Kesimpta, the drugs tracked here add up to 46% of Novartis's revenue losing US exclusivity by 2031.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Kisqali 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. Novartis 20-F: US compound patent 2031. Sales grew 58% in 2025.