27 August 2029
Repatha US antibody patent expires
A methods-of-treatment patent runs to May 2032. No confirmed US biosimilar filing yet.
When does Repatha go off patent?
In the US, biosimilars can launch from 2029. Repatha is sold by Amgen. Amgen 10-K: US antibody patent expires 27 August 2029; a methods-of-treatment patent runs to May 2032.
Repatha'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 biologic, so copies are biosimilars. Biosimilars are harder to make and usually erode sales more gradually than generics.
| Patent or protection | Covers | Expiry |
|---|---|---|
| FDA 12-year biologic exclusivity | Counted from approval on 27 August 2015 | 27 August 2027 |
| US antibody patent | Evolocumab, per Amgen | 27 August 2029 |
| US methods-of-treatment patent | Per Amgen | 10 May 2032 |
| Europe | Composition 2028 (extended to 2031 in France, Italy, Spain and the UK); methods 2032; formulation 2033 | 2028 |
Amgen's US patent on the Repatha antibody expires on 27 August 2029, two years after its 12-year biologic exclusivity, and a methods-of-treatment patent runs to May 2032. In Europe the composition patent runs to 2028, extended to 2031 in France, Italy, Spain and the UK. We found no confirmed US biosimilar filing or late-stage program. Sales grew 36% in 2025.
Sources: Amgen 10-K 2025 · FDA Purple Book
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2021 | $1.12B | $0.56B | – |
| 2022 | $1.30B | $0.61B | +16% |
| 2023 | $1.64B | $0.79B | +26% |
| 2024 | $2.22B | $1.14B | +36% |
| 2025 | $3.02B | $1.66B | +36% |
Worldwide net sales as reported, with the US share. Sources: Amgen 10-K 2025 · Amgen 10-K 2023
No US filing found We found no confirmed US biosimilar filing or late-stage program for Repatha as of October 2026. Amgen's US antibody patent runs to August 2029 and a methods patent to 2032.
Checked October 2026. Sources: Amgen 10-K 2025
Among past biologics facing biosimilars, US sales in the first full year after copies arrived were a median 65% of the last full year before (range 34% to 93%, 7 drugs), and 27% by the third year (9 drugs). Biosimilars usually take share more gradually than generics. 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 2030) | Year 2 | Year 3 |
|---|---|---|---|---|
| Fastest past case | $1.66B | $0.57B34% | $0.18B11% | $0.07B4% |
| Median | $1.66B | $1.09B65% | $0.64B38% | $0.44B27% |
| Slowest past case | $1.66B | $1.55B93% | $1.26B76% | $1.06B64% |
An illustration, not a forecast: it applies the past-cliff benchmarks to Repatha's 2025 US sales, held flat until copies arrive in 2029. Year 1 is the first full year with copies on sale.
Repatha is 8.2% of Amgen's 2025 revenue ($3.0B of $36.8B). With Prolia, Xgeva, Otezla and Enbrel, the drugs tracked here add up to 38% of Amgen's revenue losing US exclusivity by 2029.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Repatha is highlighted.
A methods-of-treatment patent runs to May 2032. No confirmed US biosimilar filing yet.