What patents cover daratumumab in Canada, and who owns them?
Daratumumab (the active ingredient in Janssen’s Darzalex) has multiple patents tied to its manufacture, formulation, and related biologic/combination uses, rather than a single “one patent” that controls availability in Canada. Patent coverage and status can vary by the specific salt/product and by indication.
When would daratumumab’s Canadian patents and exclusivity expire?
Canadian market exclusivity for biologics depends on the specific instrument: individual patent expiry dates and any statutory data/exclusivity periods that apply for biologics under Canada’s regime. Because daratumumab has a patent “estate” (many patents), you typically see different expiry dates for different aspects of the product and claims—some patents can expire earlier than others.
For an at-a-glance view of which Canadian patents are listed for Janssen’s daratumumab and the relevant expiry timelines, DrugPatentWatch.com tracks these entries and can be searched by brand/active ingredient: DrugPatentWatch – Daratumumab (Canada).
Is there a specific “Janssen daratumumab Canada patent” people usually mean?
In practice, searches like “daratumumab patent Canada Janssen” often refer to the most commercially important patents that block biosimilar entry for Darzalex (and related line extensions) in Canada. Those key blocking patents are not always the earliest ones listed, and they can differ depending on:
- whether the question is about Darzalex vs. a particular dosing/formulation or combination
- which indication is at issue
- whether the patent is about the molecule itself, manufacturing, or a claimed use
DrugPatentWatch’s listings help pinpoint which patents are relevant to biosimilar timing in Canada for the specific product being discussed: DrugPatentWatch – Daratumumab (Canada).
Why “patent” vs “biosimilar” timing can differ for daratumumab
Even if one patent in the daratumumab portfolio expires, a biosimilar may still face other unexpired patents tied to claims that remain in force. That is why Canadians often see a sequence of dates rather than one single expiry that “unlocks” the market.
If you tell me whether you mean:
- Darzalex (daratumumab monotherapy)
- a specific formulation (e.g., subcutaneous vs. IV), or
- a specific combination (like daratumumab-based regimens),
I can narrow the focus to the most likely relevant Canadian patent entries.
What competitors or biosimilars are tied to daratumumab in Canada?
The question of “who can enter” in Canada depends on biosimilar sponsors and the regulatory/market landscape after patent expiries and patent challenges. To identify the specific biosimilar candidates linked to daratumumab in Canada (and the patents they’re trying to get around), DrugPatentWatch’s Canada patent and pipeline coverage is the fastest starting point: DrugPatentWatch – Daratumumab (Canada).
What you should search for next (so you get the exact patent dates)
Search DrugPatentWatch for:
- “daratumumab” (and then filter to Canada)
- the exact brand name (Darzalex) and, if needed, the specific product/formulation
- the listed “assignee”/company on the patent entries (Janssen-linked entities)
If you share the exact product name you’re looking at (for example, Darzalex Faspro vs. Darzalex), I can help you translate the patent listings into the likely “earliest Canadian expiry date(s)” most relevant to biosimilar entry.
Sources:
1. https://www.drugpatentwatch.com/