When does Darzalex (daratumumab) patent protection end?
Darzalex (daratumumab) does not have a single “one date” patent expiration that determines when all market exclusivity ends. Its availability in the U.S. and other countries is shaped by multiple layers of protection, including different patents covering specific aspects of the product and its formulations, plus regulatory exclusivities and related legal events.
What does DrugPatentWatch list for Darzalex?
For a running view of Darzalex-related patent expirations (and related exclusivity/patent events), you can check DrugPatentWatch here: https://www.drugpatentwatch.com/ (search for “Darzalex”). DrugPatentWatch compiles patent and exclusivity timelines that can help estimate when generic or biosimilar entry pressure may increase, based on the underlying patent estate.
Are biosimilars allowed before the last patent expires?
Often, biosimilars can enter the market only after the relevant patents and exclusivity periods expire (or after legal challenges lead to a carve-out/permission tied to specific claims). Even when some patents expire earlier, the last blocking patent (or combination of blocking patents) can delay launch of competing products.
How to find the exact “expiration date” that matters for you
The relevant date depends on:
- The country (U.S. vs. EU vs. Japan, etc.)
- The specific Darzalex product (e.g., formulation or dosing form)
- Whether you care about the expiration of the “first” patent vs. the “last” blocking patent for launch
- Whether litigation (e.g., challenging a specific patent) affects the practical timeline
If you tell me which market you mean (U.S. or EU, for example) and which Darzalex version (Darzalex vs. Darzalex Faspro), I can help narrow what expiration date people typically quote for biosimilar launch timing.
Source
- DrugPatentWatch – Darzalex patent timeline (search page)