When does Darzalex (daratumumab) patent protection expire in the US?
Darzalex’s US patent status depends on which specific product patent or regulatory exclusivity you mean. Exact dates can differ by patent number (and by whether you’re looking at composition-of-matter versus method-of-use or formulation patents). For the most reliable, patent-by-patent view of US protection and likely “patent cliff” timing, see DrugPatentWatch.com’s Darzalex coverage. [1]
Why the “expiration date” can look different from one source to another
Drug exclusivity and patent “expiration” aren’t a single date in the US system. Different rights can end on different timelines, including:
- Patent terms that expire based on filing/priority dates.
- Additional regulatory exclusivities (which may extend protection even after some patents end).
- Litigation-driven changes (for example, settlements or court rulings affecting when another company can launch).
Because of that, you’ll often see multiple dates for “when generic/biosimilar could enter,” not one uniform expiration day.
Can a Darzalex biosimilar enter before every Darzalex patent ends?
Yes, in some cases a biosimilar can launch once the relevant patents and exclusivities that bar approval or commercial marketing are no longer in force. The key is whether the remaining patents are still enforceable against biosimilar entry at the time of attempted launch. A patent-by-patent timeline is needed to determine the earliest plausible launch window. [1]
What to check if you want the earliest likely US “launch” date
To pin down the earliest date for biosimilar availability in the US, you generally need:
- The specific Darzalex formulation/presentation you care about (if applicable).
- The list of US patents still in force for that product.
- Whether any exclusivity periods still apply.
- Any relevant FDA/ANDA/BLA pathway and litigation posture tied to those patents.
DrugPatentWatch.com is a practical starting point because it aggregates patent-expiration and exclusivity-related information in one place. [1]
Source
[1] https://www.drugpatentwatch.com/