April 2029
Court-upheld patents stop blocking Enbrel biosimilars
Two biosimilars are FDA-approved but cannot launch until then.
When does Enbrel go off patent?
In the US, biosimilars can launch from 2029. Enbrel is sold by Amgen. Court-upheld patents block approved biosimilars until April 2029.
Enbrel's US exclusivity date is based on settlement / court date. Litigation settlements or a court ruling fix the earliest US entry date, which makes it one of the firmer dates in this tracker. 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 |
|---|---|---|
| Fusion protein and compositions | Etanercept, per Amgen; upheld in court | 22 November 2028 |
| DNA and manufacturing methods | Per Amgen; upheld in court | 24 April 2029 |
| Formulation patents | Formulations and methods of preparing them | 19 October 2037 |
| Methods of treatment using formulations | Per Amgen | 22 February 2038 |
Amgen's patents on the etanercept fusion protein and its DNA and manufacturing run to November 2028 and April 2029, and courts upheld them against Sandoz, so the two approved biosimilars cannot launch before 2029. Formulation patents run to 2037 and 2038. Amgen sells Enbrel only in the US and Canada; Pfizer sells it elsewhere. Medicare's negotiated price took effect in January 2026, and US sales fell 33% in 2025.
Sources: Amgen 10-K 2025 · GaBI
| Year | Amgen (US and Canada) | US | Growth |
|---|---|---|---|
| 2021 | $4.46B | $4.35B | – |
| 2022 | $4.12B | $4.04B | -8% |
| 2023 | $3.70B | $3.65B | -10% |
| 2024 | $3.32B | $3.29B | -10% |
| 2025 | $2.23B | $2.20B | -33% |
Net sales as reported, with the US share. Sources: Amgen 10-K 2025 · Amgen 10-K 2023
Approved, waiting to launch Two biosimilars are FDA-approved but blocked by court-upheld patents until 2029.
| Company (product) | Stage |
|---|---|
| Sandoz (Erelzi) | FDA-approved 30 Aug 2016; barred by court until 2029 |
| Samsung Bioepis (Eticovo) | FDA-approved 25 Apr 2019; interchangeable; barred by court until 2029 |
Checked October 2026. Sources: Fierce Pharma · GaBI
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 | $2.20B | $0.75B34% | $0.23B11% | $0.09B4% |
| Median | $2.20B | $1.44B65% | $0.84B38% | $0.58B27% |
| Slowest past case | $2.20B | $2.06B93% | $1.66B76% | $1.40B64% |
An illustration, not a forecast: it applies the past-cliff benchmarks to Enbrel's 2025 US sales, held flat until copies arrive in 2029. Year 1 is the first full year with copies on sale.
Enbrel was selected for the Medicare Drug Price Negotiation Program. Its negotiated Medicare price takes effect in 2026, 67% below its list price. That is 3 years before US biosimilars 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 →
Enbrel is 6.1% of Amgen's 2025 revenue ($2.2B of $36.8B). With Prolia, Xgeva, Otezla and Repatha, 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. Enbrel is highlighted.
Two biosimilars are FDA-approved but cannot launch until then.