1 January 2027
Medicare negotiated prices for 2027 take effect
Discounts of 40% to 71% below list price for these drugs, before the rebates drugmakers already pay.
When does Calquence go off patent?
In the US, generics can launch from 2032. Calquence is sold by AstraZeneca. 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.
| Patent or protection | Covers | Expiry |
|---|---|---|
| US 7,459,554 | A drug substance patent | 24 November 2026 |
| US 9,290,504 | Acalabrutinib itself and the drug product | 11 July 2032 |
| Later patents | Uses, forms and the tablet | 1 July 2036 |
| Trial, AstraZeneca v. Cipla | Cipla generic; MSN settled in December 2025 | April 2027 |
| Europe and Japan | Key patents, per AstraZeneca | 2032 |
AstraZeneca lists US patents for Calquence expiring from 2026 to 2036; the FDA lists the patent on acalabrutinib itself to July 2032. Cipla and MSN challenged the patents in 2024. AstraZeneca settled with MSN in December 2025, and the case against Cipla is set for trial in April 2027. Outside the US, the key patents run to 2032 in Europe and Japan, with later patents to 2035 and 2036.
Sources: FDA Orange Book data files · AstraZeneca 20-F 2025
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2021 | $1.24B | $1.09B | – |
| 2022 | $2.06B | $1.66B | +66% |
| 2023 | $2.51B | $1.81B | +22% |
| 2024 | $3.13B | $2.19B | +24% |
| 2025 | $3.52B | $2.34B | +12% |
Worldwide net sales as reported, with the US share. Sources: AstraZeneca 20-F 2025 · AstraZeneca 20-F 2023
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.
| Company (product) | Stage |
|---|---|
| Cipla | Filed with the FDA; in litigation. Trial set for Apr 2027 |
| MSN | Filed with the FDA; settled Dec 2025, terms confidential |
Checked October 2026. Sources: AstraZeneca 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 →
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. See every negotiated Medicare price →
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.
Discounts of 40% to 71% below list price for these drugs, before the rebates drugmakers already pay.
AstraZeneca settled with MSN in December 2025; the case against Cipla is set for trial.
Patent-expiry estimate. AstraZeneca lists US patents expiring between 2026 and 2036; generic makers challenged them from 2024.