1 January 2027
Medicare negotiated prices for Stelara, Entresto and Xarelto stop applying
CMS removes them from the program after generics or biosimilars reached the market; their prices applied in 2026 only.
When does Stelara go off patent?
It already has. Stelara is sold by Johnson & Johnson. US biosimilars from Jan 2025. Sales were $10.4B in 2024, before entry.
Stelara'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 |
|---|---|---|
| FDA 12-year biologic exclusivity (ended) | Counted from approval on 25 September 2009 | 25 September 2021 |
| Last US composition-of-matter patent (expired) | Ustekinumab, per J&J | 2023 |
| Settlements with biosimilar makers | No US biosimilar launch before this date | 1 January 2025 |
| Europe (expired) | Composition patent with its SPC, per J&J | 2024 |
J&J's last US composition-of-matter patent on ustekinumab expired in 2023, but settlements with biosimilar makers kept them off the US market until 1 January 2025. Amgen's Wezlana launched first that month, and the FDA has approved eight Stelara biosimilars. In Europe the last composition patent, extended by an SPC, expired in 2024. Stelara's worldwide sales fell 41% in 2025.
Sources: J&J 10-K 2023 · FDA Purple Book · Center for Biosimilars: first launch
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2023 | $10.86B | $6.97B | – |
| 2024 | $10.36B | $6.72B | -5% |
| 2025 | $6.08B | $3.85B | -41% |
Worldwide net sales as reported, with the US share. Source: J&J 10-K 2025
Copies on the US market The FDA has approved 8 biosimilars. Amgen's Wezlana launched first, in January 2025, and Stelara sales fell 41% that year.
First-interchangeable exclusivity: Amgen's Wezlana was the first interchangeable biosimilar; its exclusivity as the only interchangeable ended 30 Apr 2025. FDA Purple Book (Sep 2026)
| Company (product) | Stage |
|---|---|
| Amgen (Wezlana) | FDA-approved 31 Oct 2023; launched Jan 2025; interchangeable; first interchangeable biosimilar; its exclusivity as the only interchangeable ended 30 Apr 2025. First Stelara biosimilar on the US market |
| Alvotech / Teva (Selarsdi) | FDA-approved 16 Apr 2024; launched 21 Feb 2025; interchangeable |
| Samsung Bioepis / Sandoz (Pyzchiva) | FDA-approved 28 Jun 2024; launched Feb 2025; interchangeable |
| Fresenius Kabi (Otulfi) | FDA-approved 27 Sep 2024; launched 3 Mar 2025; interchangeable |
| Accord BioPharma (Imuldosa) | FDA-approved 10 Oct 2024; launched 18 Aug 2025; interchangeable |
| Biocon Biologics (Yesintek) | FDA-approved 29 Nov 2024; launched 24 Feb 2025; interchangeable |
| Celltrion (Steqeyma) | FDA-approved 17 Dec 2024; launched Mar 2025; interchangeable |
| Bio-Thera / Hikma (Starjemza) | FDA-approved 22 May 2025; launched 6 Nov 2025; interchangeable |
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 · Center for Biosimilars: first launch · FDA Purple Book (Sep 2026) · Teva and Alvotech: Selarsdi launch · Samsung Bioepis: Pyzchiva US launch · Fresenius Kabi: Otulfi US availability · Accord BioPharma: Imuldosa launch · Biocon Biologics: Yesintek US launch · Celltrion: Steqeyma US launch · Hikma: Starjemza launch
In Q2 2026, US sales were $336M, 20% of the $1,699M in Q4 2024, the last full quarter before copies.
Amgen's Wezlana launched first; most of the other approved biosimilars followed during 2025.
| Quarter | US sales | vs Q4 2024 |
|---|---|---|
| Q4 2024 | $1,699M | 100% |
| Q1 2025 · copies launch | $981M | 58% |
| Q2 2025 | $1,078M | 63% |
| Q3 2025 | $1,022M | 60% |
| Q4 2025 | $766M | 45% |
| Q1 2026 | $220M | 13% |
| Q2 2026 | $336M | 20% |
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 →
Stelara was selected for the Medicare Drug Price Negotiation Program. Its negotiated Medicare price takes effect in 2026, 66% below its list price. CMS removed Stelara from the program from 1 January 2027 after US biosimilars reached the market, so the negotiated price applies in 2026 only. US biosimilars had already launched by then. 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 →
Stelara is 6.5% of Johnson & Johnson's 2025 revenue ($6.1B of $94.2B). With Xarelto, Simponi, Opsumit, Darzalex, Tremfya, Invega Sustenna, Imbruvica and Erleada, the drugs tracked here add up to 46% of Johnson & Johnson's revenue losing US exclusivity by 2033. Total includes MedTech.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Stelara is highlighted.
CMS removes them from the program after generics or biosimilars reached the market; their prices applied in 2026 only.
Amgen's Wezlana launched in January 2025, and several more biosimilars followed during the year. Stelara sales fell 41% in 2025. Center for Biosimilars