When does Prolia go off patent?
It already has. Prolia is sold by Amgen. Denosumab biosimilars launched in the US from mid-2025. Bone health.
Prolia's US exclusivity date is based on biosimilars 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.
| Patent or protection | Covers | Expiry |
|---|---|---|
| RANKL antibody patents (expired) | Denosumab itself, including its sequences | February 2025 |
| Europe (expired) | The same patents, in select countries | November 2025 |
| Suits against later biosimilar makers | Henlius with Organon, Amneal with mAbxience, Dr. Reddy's with Alvotech, and Alkem | Pending |
Amgen's patents on denosumab itself expired in February 2025 in the US and in November 2025 in select European countries. The FDA has approved Prolia biosimilars from 10 companies, and the first launched in June 2025. Amgen is still suing four later entrants over other patents; those cases are at an early stage, with no trial before 2028. Amgen expects sales to erode faster in 2026 as more biosimilars launch.
Sources: Amgen 10-K 2025 · FDA Purple Book
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2021 | $3.25B | $2.15B | – |
| 2022 | $3.63B | $2.46B | +12% |
| 2023 | $4.05B | $2.73B | +12% |
| 2024 | $4.37B | $2.88B | +8% |
| 2025 | $4.41B | $2.98B | +1% |
US biosimilars launched from June 2025. Worldwide net sales as reported, with the US share. Sources: Amgen 10-K 2025 · Amgen 10-K 2023
Copies on the US market The FDA has approved Prolia biosimilars from 10 companies; launches began in 2025 after Amgen's US patents expired in February.
First-interchangeable exclusivity: Sandoz's Jubbonti was the first interchangeable biosimilar; its exclusivity as the only interchangeable ended 29 Oct 2025. FDA Purple Book (Sep 2026)
| Company (product) | Stage |
|---|---|
| Sandoz (Jubbonti) | FDA-approved 5 Mar 2024; launched 2 Jun 2025; interchangeable; first interchangeable biosimilar; its exclusivity as the only interchangeable ended 29 Oct 2025 |
| Samsung Bioepis (Ospomyv) | FDA-approved 13 Feb 2025; launched 2026; interchangeable. Sold in the US under a private label by Cordavis (CVS Health) |
| Celltrion (Stoboclo) | FDA-approved 28 Feb 2025; launched Jul 2025; interchangeable |
| Fresenius Kabi (Conexxence) | FDA-approved 25 Mar 2025; launched Jul 2025; interchangeable |
| Henlius (Bildyos) | FDA-approved 29 Aug 2025; interchangeable |
| Biocon Biologics (Bosaya) | FDA-approved 16 Sep 2025; launched 7 Apr 2026; interchangeable |
| Hikma (Enoby) | FDA-approved 26 Sep 2025; launched 19 Jan 2026; interchangeable |
| Accord BioPharma (Osvyrti) | FDA-approved 29 Oct 2025; launched 23 Jul 2026; interchangeable |
| Amneal (Boncresa) | FDA-approved 19 Dec 2025; interchangeable |
| Teva (Ponlimsi) | FDA-approved 27 Mar 2026; interchangeable |
| Alvotech / Dr. Reddy's (AVT03) | Filed with the FDA; in litigation, sued Nov 2025. FDA turned it down in Dec 2025 over factory issues only; back under review after the FDA cleared the factory in Jul 2026 |
Approval dates are from the FDA's own lists. A maker shows as launched only when its own release or filing confirms it; FDA-approved means a launch is not confirmed, not that the copy is off the market. Checked October 2026. Sources: FDA Purple Book · Amgen 10-K 2025 · Sandoz: Jubbonti and Wyost US launch · FDA Purple Book (Sep 2026) · Samsung Epis Holdings: Q2 and H1 2026 results · Samsung Epis Holdings: Q1 2026 results (Cordavis partnership) · Celltrion: Stoboclo and Osenvelt US launch · Fresenius Kabi: Conexxence and Bomyntra US launch · Biocon Biologics: Bosaya and Aukelso US launch · Hikma: Enoby and Xtrenbo launch · Accord BioPharma: Osvyrti and Jubereq launch · Alvotech 20-F 2025 (FDA letters) · Alvotech: FDA clears Reykjavik facility, 5 Oct 2026
In Q2 2026, US sales were $478M, 66% of the $720M in Q1 2025, the last full quarter before copies.
Denosumab biosimilars launched from mid-2025 under settlements with Amgen; erosion sped up once several were on sale.
| Quarter | US sales | vs Q1 2025 |
|---|---|---|
| Q4 2024 | $775M | 108% |
| Q1 2025 | $720M | 100% |
| Q2 2025 · copies launch | $745M | 103% |
| Q3 2025 | $806M | 112% |
| Q4 2025 | $707M | 98% |
| Q1 2026 | $461M | 64% |
| Q2 2026 | $478M | 66% |
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 →
Prolia is 12% of Amgen's 2025 revenue ($4.4B of $36.8B). With Xgeva, Otezla, Repatha 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. Prolia is highlighted.