Darzalex patent expiration date?

Darzalex (daratumumab) – Patent Status

Bottom line:
The core drug‑product patents for Darzalex are scheduled to expire in the early‑2030s (most around 2033). The method‑of‑use patents, which are often the strongest barrier to generics, are set to expire a few years later, in the mid‑2030s. Because of the layered nature of the patent portfolio, it is unlikely that a generic version of Darzalex could be launched until the mid‑2030s at the earliest.

Why it matters
Darzalex is a monoclonal antibody that was approved by the FDA in 2015. Its patents were filed over a decade ago, and the standard 20‑year term from filing means the patents naturally slide into the 2030s. Until those patents expire, any generic or biosimilar entrant would need to seek FDA approval through the Biologics License Application (BLA) pathway and must still comply with the Biosimilar and Generic Drugs (BGD) Act.

Key Takeaway
The main DARZALEX patents will likely expire around 2033–2034 for the drug product, and 2036–2037 for the method of use. Consequently, the drug’s monopoly period will stretch into the mid‑2030s, and generic competition is not expected before then.