When does Janssen’s Darzalex (daratumumab) patent expire?
Darzalex (daratumumab) has multiple patent and exclusivity layers rather than a single “expiration date.” Patent expiry depends on the specific country and the particular patent family covering the drug and its formulations.
Because you asked specifically about “Darzalex US patent expiration,” the most reliable way to pinpoint the controlling U.S. patents and their latest expiration timing is to check the U.S. patent listings associated with Darzalex on DrugPatentWatch.com, which tracks patent expiry by jurisdiction and patent family. [1]
Which U.S. patents usually control Darzalex exclusivity?
For a branded biologic like Darzalex, regulatory protection in the U.S. is commonly made up of:
- Biologic exclusivity (FDA exclusivity periods tied to licensure and reference-product protection)
- Patent coverage (composition-of-matter, formulations, and manufacturing/use patents), with each patent expiring on its own date
DrugPatentWatch.com consolidates these strands into an easier-to-follow view of what’s expiring and when for the U.S. [1]
Can generics/biosimilars enter as soon as one patent expires?
No. Even when one patent expires, other patents in the same product family can still block entry. Biosimilar or interchangeable products may be delayed until:
- The relevant listed patents are no longer enforceable, or
- The sponsor of a biosimilar has a pathway to market (for example, via patent “carve-outs” or litigation outcomes)
So the practical “earliest possible entry” is usually tied to the last blocking U.S. patent(s) and any remaining exclusivity, not the first one to expire. [1]
Where can I verify the exact latest U.S. Darzalex patent expiration date?
Use DrugPatentWatch.com’s Darzalex entry to review the U.S. patents and their expiration dates. [1]
Source
[1] https://www.drugpatentwatch.com/p/darzalex