Pharma Patent Cliffby readouts.io
Loss of exclusivity · US · 2025

Drugs that went off patent in 2025

Which drugs went off patent in 2025?

Four blockbuster drugs with $20.3B in 2025 worldwide sales lost US exclusivity in 2025, led by Entresto (Novartis, $7.7B). One is a small-molecule drug that went generic and three are biologics that faced biosimilars.

Drugs losing US exclusivity
4Already facing US copies
2025 worldwide sales
$20.3B#6 of 12 years tracked
Largest drug
EntrestoNovartis · $7.7B
Most exposed company
Novartis14% of 2025 revenue

The 4 drugs

DrugCompanyArea2025 salesDate basisUS copiesMedicare price
Entresto Novartis Cardiometabolic $7.7B Generics launched Copies on the US market 2026 · −53%
Stelara Johnson & Johnson Immunology $6.1B Generics launched Copies on the US market 2026 · −66%
Prolia Amgen Other $4.4B Generics launched Copies on the US market –
Xgeva Amgen Oncology $2.1B Generics launched Copies on the US market –

Every date here is fixed by a launch, settlement, court ruling or company guidance. Each drug's page has the sources.

Companies most exposed in 2025

CompanyDrugs2025 revenue from themShare of company
NovartisEntresto$7.7B14%
AmgenProlia and Xgeva$6.5B18%
Johnson & JohnsonStelara$6.1B6.5%

For shared drugs, each company is credited with the revenue it reports, so nothing is counted twice. Share is of the company's total 2025 revenue.

What happened

US generics and biosimilars could launch from 2025. Generic launches usually take most of a drug's US volume within months. Biosimilars usually erode a biologic's sales more gradually, because they are harder to make and switching takes longer. Entresto and Stelara were also selected for Medicare price negotiation, which can cut Medicare revenue before or alongside US copies.

US exclusivity can end earlier or later than these dates if a court ruling, settlement or new patent changes the picture. See what happened to sales after past patent cliffs →

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Pharma Patent Cliff by readouts.io. "Drugs going off patent in 2025." Updated 28 September 2026. https://pharmapatentcliff.com/off-patent/2025

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