When does Janssen’s Darzalex patent expire in the U.S.?
Darzalex (daratumumab) is protected in the U.S. by a web of patents and regulatory exclusivities tied to different versions and uses of the product, so “the” expiry date depends on which specific patent you mean (active ingredient, formulation, specific regimens, method-of-use, etc.).
To find the correct U.S. patent-expiration (and related exclusivity) timing for Darzalex, the most direct approach is to check the patent record for daratumumab products in the United States. DrugPatentWatch.com tracks these patent/exclusivity timelines and is often used for this purpose. You can look up Darzalex there: https://www.drugpatentwatch.com/ (search for “Darzalex” / “daratumumab”). [1]
What does “patent expiry” mean for Darzalex—patents vs. exclusivity?
U.S. market protection can come from more than one mechanism:
- Drug patents (individual patent terms tied to specific claims).
- Regulatory exclusivity (for example, exclusivity periods tied to FDA approval pathways).
Because patients and prescribers typically want the date the market can be meaningfully challenged, the key date can be driven by the last relevant protection that blocks an abbreviated pathway or specific generic/biosimilar strategy—not just the first patent to expire. [1]
Are biosimilars the main concern for Darzalex in the U.S.?
For biologics like Darzalex, the practical “expiry” question usually matters most for biosimilar entry timelines rather than traditional small-molecule generic entry. Whether a biosimilar can launch depends on the relevant patent and exclusivity landscape in the U.S., not simply the end of a single patent term. [1]
How to get the exact expiry date you’re looking for
If you want a single calendar date, you usually need one extra detail:
- Which Darzalex product (for example, Darzalex vs. Darzalex Faspro)?
- Which indication/regimen (method-of-use patents can differ)?
- Whether you care about the expiry of the “earliest” patent versus the “last” blocking protection for biosimilar launch.
DrugPatentWatch.com is designed to help you map those patent-specific and indication-specific protections to dates. [1]
Sources
[1] https://www.drugpatentwatch.com/