Pharma Patent Cliffby readouts.io
Loss of exclusivity · Other

Prolia patent expiration

Prolia (Amgen) has faced US biosimilar competition since 2025. Denosumab biosimilars launched in the US from mid-2025. Bone health.

US loss of exclusivity
2025Generics launched
2025 worldwide sales
$4.4BAmgen
Therapeutic area
Other
US competition from
BiosimilarsUS date shown

What the date means

Prolia's US exclusivity date is based on generics launched. US biosimilars have already launched, so the loss of exclusivity is under way. It is a biologic, so copies are biosimilars. Biosimilars are harder to make and usually erode sales more gradually than generics.

What's at stake for Amgen

Amgen
18%

Prolia is 12% of Amgen's 2025 revenue ($4.4B of $36.8B). With Enbrel, 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. Prolia is highlighted.

Other blockbusters losing US exclusivity in 2025

Sources

  1. Amgen FY2025
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