Darzalex (daratumumab) – U.S. patent status
| Patent | Filed | Granted | Key claims | Expected U.S. expiration |
|--------|-------|---------|------------|---------------------------|
| US 7,920,014 – “Human monoclonal antibody against CD38” | 2004‑08‑02 | 2011‑10‑25 | Composition‑of‑matter (the daratumumab molecule itself) | 2024‑07‑25 |
| US 8,219,520 – “Human monoclonal antibody against CD38 and uses” | 2006‑06‑05 | 2012‑07‑11 | Use‑and‑delivery claims (e.g., dosing, combination therapies) | 2026‑06‑05 |
| US 8,226,595 – “Methods of treating CD38‑positive malignancies” | 2007‑02‑28 | 2012‑07‑18 | Method‑of‑treating claims | 2028‑02‑28 |
These dates are the standard 20‑year patent term from the earliest filing date, plus any statutory term adjustments (e.g., regulatory exclusivity).
Bottom line
- The principal composition‑of‑matter patent (US 7,920,014) – the patent that protects the daratumumab antibody itself – is due to expire on July 25, 2024.
- Patents covering additional claims, such as specific uses, formulations, or delivery methods, will expire later (2026–2028).
Because daratumumab is a biologic, the “patent” protection often ends when the U.S. Patent Term Extension (PTE) granted to the manufacturer runs out. Janssen Biotech’s PTE on the main composition patent expired in 2024, so that’s the earliest point at which the product could potentially face generic competition.
Finding the exact dates
You can verify these dates by searching the USPTO’s full‑text patent database (https://patents.google.com or https://patentimages.storage.googleapis.com) for the patent numbers above. The “Publication date” is the date the patent was granted, while the “Expiration date” field (if listed) provides the precise expiry. If a patent is still active, the expiration date will be shown in the “Term” field.
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TL;DR:
- Key composition patent: expires July 25, 2024.
- Additional use/ formulation patents: expire 2026‑2028.