2032, date not disclosed
Tagrisso expected to lose US exclusivity
Patent-expiry estimate. Core US patents expire in 2032. Later patents cover the formulation (2035) and one approved use (2042).
When does Tagrisso go off patent?
In the US, generics can launch from 2032. Tagrisso is sold by AstraZeneca. Core US patents expire in 2032. Later patents cover the formulation (2035) and one approved use (2042).
Tagrisso'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 8,946,235 | Osimertinib itself and the drug product | 8 August 2032 |
| US 9,732,058 | Osimertinib itself and the drug product | 25 July 2032 |
| US 11,524,951 | Osimertinib itself and the drug product | 25 July 2032 |
| US 10,183,020 | The drug product (formulation) | 2 January 2035 |
| US 12,465,608 | One specific approved use (listed December 2025) | 26 November 2042 |
The compound patents set the earliest likely generic entry, in 2032. Generic makers can challenge or work around the later patents on the formulation (2035) and one use (2042). FDA also lists new-indication and orphan exclusivities running to 2027. AstraZeneca has disclosed no US generic challenge. Separately, Wyeth sued AstraZeneca claiming Tagrisso infringed Wyeth patents; a jury awarded $107.5M in 2024, the court then ruled those patents invalid, and Wyeth has appealed. That case is about damages, not about when generics can launch.
Sources: FDA Orange Book: Tagrisso patents · AstraZeneca 20-F 2025
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2023 | $5.80B | $2.28B | – |
| 2024 | $6.58B | $2.76B | +13% |
| 2025 | $7.25B | $3.06B | +10% |
Worldwide net sales as reported, with the US share. Source: AstraZeneca 20-F 2025
No US filing found AstraZeneca discloses no US generic challenge to Tagrisso in its 2025 annual report.
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 →
Tagrisso is 12% of AstraZeneca's 2025 revenue ($7.3B of $58.7B). With Farxiga, Lynparza, Imfinzi, Calquence 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. Tagrisso is highlighted.
Patent-expiry estimate. Core US patents expire in 2032. Later patents cover the formulation (2035) and one approved use (2042).