Kisqali (Novartis) is expected to face US generic competition from 2031. 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.
Among past small-molecule drugs facing generics: Tecfidera's US sales fell to 21% of their 2019 level in its first full year of generics (2021); Revlimid's US sales fell to 96% of their 2021 level in its first full year of generics (2022) and 57% two years later. Where settlements cap generic volumes, as with Revlimid, the decline is slower. See how past cliffs played out →
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 September 2026. Sources: Novartis 20-F 2025
Kisqali was selected for the Medicare Drug Price Negotiation Program. CMS is negotiating its Medicare price now; the price takes effect in 2028 and is due to be published 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.
Kisqali is 8.8% of Novartis's 2025 revenue ($4.8B of $54.5B). With Entresto, Cosentyx and Kesimpta, the drugs tracked here add up to 43% 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.