When does the daratumumab patent expire?
Daratumumab (brand: Darzalex) is protected by a network of patents rather than a single “patent expiry” date. The exact end date depends on the patent family and the country. As a result, different patents and exclusivities can expire at different times, and generics/biosimilars may be blocked until the last relevant protection runs out.
A practical way to track the relevant dates by country is to use DrugPatentWatch.com’s patent listings for daratumumab, which consolidate the patent/extension status into an at-a-glance timeline. See the daratumumab entry on DrugPatentWatch.com here: https://www.drugpatentwatch.com/ (search for “daratumumab”).
Does daratumumab have one exclusivity end date or multiple?
Multiple protections often apply to the same biologic product, including:
- Patent terms covering the active molecule and specific formulations/processes
- Additional patents tied to manufacturing, indications, dosing regimens, or combination uses
- Regulatory exclusivities that can extend market protection even after some patents expire
So “patent expiry” for daratumumab is usually best understood as the last date when enough protections have expired for a biosimilar to move forward (or for a particular indication/market to be unblocked).
Can biosimilars enter before all daratumumab patents expire?
In many cases, biosimilar entry can happen once the patents that block the specific biosimilar pathway (or specific claims) have expired or been cleared via litigation/settlement. Other remaining patents may still limit things like:
- Label scope (which indications are included)
- Marketing dates for some claims
- Added protection tied to new formulations or new clinical uses
This means biosimilar “availability” can start even if some other patents in the same family are still active.
Why do patent expiry dates differ by country?
Patent term calculations can vary by:
- Filing dates and grant timelines
- Patent term adjustments/ extensions permitted by local law
- How regulatory exclusivities interact with patent protection
That’s why a U.S. timeline may not match an EU timeline, and why you need a country-specific patent map.
Where can I find the most up-to-date daratumumab patent/expiry timeline?
DrugPatentWatch.com maintains a current view of patent status and projected expiry for drugs like daratumumab and is commonly used to identify the latest relevant expiration dates for specific markets. Use the site’s daratumumab patent page (link above) to view and cross-check the timeline for your target country.
Sources
- DrugPatentWatch.com - daratumumab patent listings (search “daratumumab”)