2029, date not disclosed
Darzalex expected to lose US exclusivity
Patent-expiry estimate. Core US patents expire 2029. Formulation patents on subcutaneous Darzalex Faspro run longer.
When does Darzalex go off patent?
In the US, biosimilars can launch from 2029. Darzalex is sold by Johnson & Johnson. Core US patents expire 2029. Formulation patents on subcutaneous Darzalex Faspro run longer.
Darzalex's US exclusivity date is based on patent-expiry estimate. It is estimated from patent expiry rather than a fixed entry date, so it may move as patents are challenged or extended. 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 |
|---|---|---|
| Genmab compound and use patents (two families, licensed to J&J) | Daratumumab itself and its uses | 2029 |
| J&J patents on Darzalex Faspro and Darzalex IV | The under-the-skin (with hyaluronidase) and IV products | Not disclosed |
J&J says both Genmab patent families expire in the US in 2029; in Europe, compound and use protection in some countries runs to 2031 or 2032. J&J pays Genmab royalties of 12% to 20% of Darzalex sales, about $2.4B in 2025. Because J&J holds separate patents on the under-the-skin Darzalex Faspro, a biosimilar of the IV form would not automatically be able to copy it; Henlius and Dr. Reddy's are testing a copy of the under-the-skin version.
Sources: J&J 10-K 2025
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2023 | $9.74B | $5.28B | – |
| 2024 | $11.67B | $6.59B | +20% |
| 2025 | $14.35B | $8.27B | +23% |
Worldwide net sales as reported, with the US share. Source: J&J 10-K 2025
In clinical trials The most advanced biosimilar, Celltrion's, is in Phase 3. Henlius and its partner Dr. Reddy's are testing a copy of the under-the-skin version.
| Company (product) | Stage |
|---|---|
| Celltrion (CT-P44) | In clinical trials |
| Henlius / Dr. Reddy's (HLX15) | In clinical trials. First patient dosed May 2026 |
Checked October 2026. Sources: Lexology: Celltrion Phase 3 · Pearce IP: Henlius US 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 2030) | Year 2 | Year 3 |
|---|---|---|---|---|
| Fastest past case | $8.27B | $2.81B34% | $0.88B11% | $0.35B4% |
| Median | $8.27B | $5.40B65% | $3.17B38% | $2.20B27% |
| Slowest past case | $8.27B | $7.72B93% | $6.25B76% | $5.26B64% |
An illustration, not a forecast: it applies the past-cliff benchmarks to Darzalex's 2025 US sales, held flat until copies arrive in 2029. Year 1 is the first full year with copies on sale.
Darzalex is 15% of Johnson & Johnson's 2025 revenue ($14.3B of $94.2B). With Stelara, Xarelto, Simponi, Opsumit, 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. Darzalex is highlighted.
Patent-expiry estimate. Core US patents expire 2029. Formulation patents on subcutaneous Darzalex Faspro run longer.