Pharma Patent Cliffby readouts.io
Loss of exclusivity · Immunology

Enbrel patent expiration

Enbrel (Amgen) is expected to face US biosimilar competition from 2029. Court-upheld patents block approved biosimilars until April 2029.

US loss of exclusivity
2029Settlement / court date
2025 worldwide sales
$2.2BAmgen
Therapeutic area
Immunology
Medicare negotiated price
−67%From 2026, vs list price
US competition from
BiosimilarsUS date shown

What the date means

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.

Medicare price negotiation

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.

What changed for Enbrel

  1. Medicare price
    First Medicare prices set, including Eliquis, Farxiga, Entresto, Enbrel and Stelara

    From 2026: Farxiga 68%, Enbrel 67%, Stelara 66%, Eliquis 56% and Entresto 53% below list price. CMS

What's at stake for Amgen

Amgen
18%

Enbrel is 6.1% of Amgen's 2025 revenue ($2.2B of $36.8B). With Prolia, the drugs tracked here add up to 18% 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.

Other blockbusters losing US exclusivity in 2029

Sources

  1. Amgen FY2025
  2. GaBI
  3. CMS: negotiated prices for 2026
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