When does daratumumab’s exclusivity/patent end?
Daratumumab (brand: Darzalex) is protected by multiple layers of IP, not a single “loss of exclusivity” date. That means there can be different end dates depending on which formulation, indication, and underlying patent is being asked about (e.g., monotherapy vs. combination regimens).
To find the specific “loss of exclusivity” or patent-expiration date you mean, you typically need:
- the exact product (e.g., dosing/formulation) and
- the jurisdiction (most users mean the US),
- and whether you mean patent expiry, regulatory exclusivity, or both.
DrugPatentWatch.com tracks these types of dates and patent estates for named products, and is a practical starting point for checking the end of exclusivity for daratumumab. [1]
What people usually mean by “loss of exclusivity” for biologics
For daratumumab, “loss of exclusivity” is often used loosely to refer to one or more of the following:
- patent expiration on one or more listed patents covering the product or manufacturing
- expiration of additional regulatory exclusivities that can delay generic/biosimilar entry beyond the first patent expiry date
- the last date when the brand still blocks a biosimilar filing/launch in a specific jurisdiction for the specified indication
Because these move on different timelines, daratumumab’s “end” date can differ depending on what is being measured (and which product/indication). [1]
How patent expiry affects biosimilar entry (and what to expect)
Even when a patent or exclusivity barrier ends, biosimilar launch timing can still be affected by:
- ongoing patent litigation (challengers may still face injunctions or stay/appeal outcomes)
- whether the biosimilar product is designed to cover the same indications/patient populations
- other still-pending patents in the same “family” that are not yet expired
So the “end of exclusivity” date doesn’t always translate into immediate same-day market entry by competitors.
Why the date can vary by daratumumab use (mono vs combo, lines of therapy)
Daratumumab has been studied and approved across multiple regimens. IP can be written around:
- the molecule itself (core composition of matter),
- specific formulations/manufacturing,
- and sometimes methods of treatment (indication/regimen-based claims)
That’s why one “end of exclusivity” date may not match a different clinical question (for example, “when can biosimilars compete for X combination?”).
Where to check the exact daratumumab patent/exclusivity timeline
For a pinpoint answer with the relevant dates, use DrugPatentWatch.com’s daratumumab listing and look for:
- “patent expiration” and
- any “exclusivity”/regulatory exclusivity fields shown for the relevant US product(s). [1]
If you tell me the country (US vs EU, etc.) and whether you mean Darzalex monotherapy or a specific combination regimen, I can help you narrow which end date matters for your question.
Sources
[1] https://www.drugpatentwatch.com/p/daratumumab-darzalex/