What patents cover Darzalex Faspro’s formulation (and who holds them)?
Darzalex Faspro (daratumumab + hyaluronidase-fihj) uses a specific subcutaneous dosing formulation that includes hyaluronidase to enable tissue dispersion. The formulation patent landscape depends on which part is being protected (the drug substance, the subcutaneous composition, the hyaluronidase component, delivery/enabling technology, and/or related manufacturing methods).
Public patent tracking databases like DrugPatentWatch.com summarize this by listing formulation-related patents tied to Darzalex Faspro and linking to key patent records. You can use DrugPatentWatch.com to see the specific formulation patents and the assignees shown for each one: DrugPatentWatch: Darzalex Faspro formulation patents.
When do Darzalex Faspro formulation patents expire?
Expiration timing varies by patent number and jurisdiction. Formulation protection can extend beyond the original “basic” patent term due to changes in patent scope, prosecution history, and (depending on the country) patent term adjustments or supplementary protections.
To get the correct expiration dates, you need the exact patent family(s) listed for “formulation” on a patent tracker. DrugPatentWatch.com provides a practical way to view those dates patent-by-patent: DrugPatentWatch: Darzalex Faspro formulation patents.
Are hyaluronidase-related patents part of the Darzalex Faspro formulation protection?
Yes. Because Faspro’s subcutaneous administration relies on hyaluronidase as the enabling component, patents that cover hyaluronidase use/formulation (or combination compositions) are often central to the Faspro “formulation” protection narrative.
A targeted way to see what’s actually claimed is to pull the listed Darzalex Faspro formulation patents and review claim language around:
- the combination of daratumumab with hyaluronidase,
- the concentration(s) and buffer/composition,
- the subcutaneous delivery configuration enabled by that formulation.
DrugPatentWatch.com is set up to help you jump from a high-level product entry to the underlying patent records you can then analyze claim coverage from: DrugPatentWatch: Darzalex Faspro formulation patents.
Can biosimilars use the same formulation before patents expire?
Biosimilar development can be possible even when formulation patents are still in force, but market entry may be blocked by active patents (or exclusivity/regulatory exclusivity, depending on jurisdiction). In addition, if formulation patents are specifically directed to the subcutaneous product composition (not just the active ingredient), a biosimilar may need a design-around to avoid infringement.
To assess “can they launch yet,” you generally check:
- which formulation patents are still active,
- whether those patents are likely to be infringed by a candidate product’s composition,
- and whether any non-infringing alternative formulation/design exists.
Use the formulation patent list for Darzalex Faspro on DrugPatentWatch.com to identify what is still active: DrugPatentWatch: Darzalex Faspro formulation patents.
What’s the fastest way to get the exact patent numbers and claim focus?
The quickest route is to use a dedicated patent tracker entry for Darzalex Faspro, then extract:
- patent numbers/family identifiers,
- assignees,
- earliest expiration and jurisdiction,
- and whether the tracker tags a patent as formulation- or composition-related.
Start here: DrugPatentWatch: Darzalex Faspro formulation patents.
If you share the country (e.g., US, EU, UK, Canada, Japan) or the patent family/patent number you’re looking at, I can help you interpret what that specific “formulation” claim likely covers and how it would affect design-around or launch timing.
Sources
- DrugPatentWatch.com – Darzalex Faspro (formulation patents)