Calquence (AstraZeneca) is expected to face US generic competition from 2032. AstraZeneca lists US patents expiring between 2026 and 2036; generic makers challenged them from 2024.
Calquence's US exclusivity date is based on patent-expiry estimate. It is estimated from patent expiry rather than a fixed entry date, so it may move as patents are challenged or extended. 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 →
Filed with the FDA Cipla and MSN challenged Calquence's patents in 2024. AstraZeneca settled with MSN in December 2025; the case against Cipla is set for trial in April 2027.
Checked September 2026. Sources: AstraZeneca 20-F 2025
Calquence was selected for the Medicare Drug Price Negotiation Program. Its negotiated Medicare price takes effect in 2027, 40% below its list price. That is 5 years before US generics can launch, so Medicare revenue comes under pressure first. The discount is measured against list price, before the rebates drugmakers already pay, and applies to Medicare only, so the revenue impact is smaller than the headline number.
Calquence is 6% of AstraZeneca's 2025 revenue ($3.5B of $58.7B). With Farxiga, Lynparza, Imfinzi, Tagrisso and Ultomiris, the drugs tracked here add up to 57% of AstraZeneca's revenue losing US exclusivity by 2035.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Calquence is highlighted.