2031, date not disclosed
Tremfya expected to lose US exclusivity
Company guidance. J&J 10-K: US composition patent family projected to expire in 2031. Sales grew 40% in 2025, which J&J attributes to share gains and market growth.
When does Tremfya go off patent?
In the US, biosimilars can launch from 2031. Tremfya is sold by Johnson & Johnson. J&J 10-K: US composition patent family projected to expire in 2031. Sales grew 40% in 2025, which J&J attributes to share gains and market growth.
Tremfya's US exclusivity date is based on company guidance. The date comes from the company's own filings or guidance. Secondary patents, new formulations or litigation can still move it. 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 | Counted from approval on 13 July 2017 | 13 July 2029 |
| Composition patent family | Guselkumab, per J&J | 2031 |
J&J projects its composition patent family for Tremfya to expire in the US in 2031, two years after its 12-year biologic exclusivity ends in July 2029. J&J does not give dates outside the US. Biosimilars are at an early stage: Celltrion got approval in Korea to start its first trial in July 2026, and Samsung Bioepis, Alvotech and Polpharma also have programs. Sales grew 40% in 2025.
Sources: J&J 10-K 2025 · FDA Purple Book
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2021 | $2.13B | $1.50B | – |
| 2022 | $2.67B | $1.84B | +25% |
| 2023 | $3.15B | $2.15B | +18% |
| 2024 | $3.67B | $2.44B | +17% |
| 2025 | $5.16B | $3.53B | +40% |
Worldwide net sales as reported, with the US share. Sources: J&J 10-K 2025 · J&J 10-K 2023
In clinical trials Celltrion won approval in Korea for a first trial of its Tremfya biosimilar in July 2026. Samsung Bioepis, Alvotech and Polpharma also have programs.
| Company (product) | Stage |
|---|---|
| Celltrion (CT-P68) | In clinical trials. Phase 1 approved in Korea (Jul 2026) |
| Samsung Bioepis | Early development |
| Alvotech | Early development |
| Polpharma (PB019) | Early development |
Checked October 2026. Sources: Pearce IP: Celltrion trial
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 →
| Scenario | 2025 US sales | Year 1 (about 2032) | Year 2 | Year 3 |
|---|---|---|---|---|
| Fastest past case | $3.53B | $1.20B34% | $0.38B11% | $0.15B4% |
| Median | $3.53B | $2.30B65% | $1.35B38% | $0.94B27% |
| Slowest past case | $3.53B | $3.30B93% | $2.67B76% | $2.24B64% |
An illustration, not a forecast: it applies the past-cliff benchmarks to Tremfya's 2025 US sales, held flat until copies arrive in 2031. Year 1 is the first full year with copies on sale.
Tremfya is 5.5% of Johnson & Johnson's 2025 revenue ($5.2B of $94.2B). With Stelara, Xarelto, Simponi, Opsumit, Darzalex, 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. Tremfya is highlighted.
Company guidance. J&J 10-K: US composition patent family projected to expire in 2031. Sales grew 40% in 2025, which J&J attributes to share gains and market growth.