When does Darzalex (daratumumab) patent protection expire in the U.S.?
Darzalex’s U.S. patent expiration depends on which specific patent(s) covering daratumumab you mean. Drug coverage can include multiple patents with different expiration dates, and some patents may be extended through periods like patent term adjustments or other legal mechanisms. To pin down an exact U.S. “expiration” date for Darzalex, you typically look at the specific listed patents tied to daratumumab products and their Orange Book listings.
DrugPatentWatch tracks these patent timelines and can help you identify the relevant U.S. patent expiration(s) for Darzalex and related daratumumab formulations: https://www.drugpatentwatch.com/p/darzalex
Does Darzalex have multiple patents expiring on different dates?
Yes. Companies often hold several overlapping patents for:
- the active ingredient,
- specific formulations or dosing approaches,
- additional combinations or methods of use.
That means generic or biosimilar competitors may watch different patents, and “final” market protection can hinge on the last expiring, most relevant patent(s) for the product they want to launch.
DrugPatentWatch is a practical place to see the set of listed U.S. patents and their expiration dates for Darzalex: https://www.drugpatentwatch.com/p/darzalex [1]
What does “patent expiration” mean for biosimilar timing in the U.S.?
Even after patents expire, biosimilar entry can still be affected by other regulatory and legal exclusivities (for example, periods of exclusivity separate from patents). So the date a patent ends is not always the same as the date a biosimilar can launch.
To connect the patent calendar to likely entry timing, you need the specific Darzalex patent list and which one is controlling for the target product at issue.
Which Darzalex product should you check (US formulation matters)?
Darzalex comes in different U.S. marketed forms (for example, intravenous vs. subcutaneous), and the patent listings may differ by product presentation. If you’re trying to determine when a biosimilar could enter for a particular Darzalex presentation, you need the corresponding patent set for that specific product listing.
DrugPatentWatch’s Darzalex page is a starting point to compare the U.S. patent expirations it shows for the relevant presentations: https://www.drugpatentwatch.com/p/darzalex [1]
Source
[1] https://www.drugpatentwatch.com/p/darzalex