Daratumumab patent expiration?

Daratumumab (brand name Darzalex) – patent landscape overview

Bottom line:
The earliest patent that covers daratumumab (the composition‑of‑matter/antibody itself) expires in early 2025 (US) or late 2025 (EU), depending on the specific filing.
The latest patents in the portfolio, especially the EU “patent” covering the whole European market and some manufacturing‑process patents, run until mid‑2027 to late‑2028.

What this means for market entry

1. Generic/biologic competition – Once the composition‑of‑matter patent expires, companies can legally develop a generic‑style antibody (often called a biosimilar).
2. “Patent thicket” protection – Even if one key patent expires, other overlapping patents (methods of use, manufacturing, formulation) can still shield the product until they expire.
3. Biosimilar entry timeline – In the US, the first biosimilar to daratumumab could be approved after the earliest composition‑of‑matter patent expires (2025) if all related patents are also clear. In the EU, the timeline is similar, but regulatory approval also depends on the European Medicines Agency’s (EMA) assessment.

How to stay up‑to‑date

Key takeaway: While the core antibody patents will expire around 2025‑2026, other related patents in the portfolio extend protection until the mid‑2020s. Consequently, the first biosimilar or generic‑style entry is likely to come in the late‑2020s, contingent on the status of the overlapping patents.