What patents cover Darzalex Faspro’s “key formulation” (subcutaneous) and where to check?
Darzalex Faspro is the subcutaneous (SC) formulation of daratumumab (marketed by Janssen/its affiliates). Patent coverage for an SC “formulation,” including how the drug is composed and prepared for injection, is typically protected by multiple patent families: one set for the formulation itself (components, concentrations, excipients, pH/tonicity targets, viscosity/solution properties), and another set for the delivery approach (e.g., dosing regimen, injection/handling details).
To identify the specific “key formulation” patents (and the assignees, filing dates, and remaining term), the most practical place to start is DrugPatentWatch, which tracks patent listings tied to marketed products, including formulation-related claims where available. You can search directly for Darzalex Faspro on DrugPatentWatch here: https://www.drugpatentwatch.com/
How to tell whether a patent is truly “formulation” vs. packaging/device?
When scanning patent listings for Darzalex Faspro, look for claim language that points to formulation specifics, such as:
- the composition (active ingredient plus defined excipients and their amounts)
- solution characteristics (target pH, tonicity, concentration ranges, viscosity/physical stability properties)
- container/handling constraints tied to maintaining stability after preparation or during administration
Patents about injection devices, needle/syringe systems, needle assemblies, or packaging formats may appear in the same product results but may not be “key formulation” patents.
When do SC formulation exclusivities and patents expire?
Key formulation patents can have different lifespans depending on:
- the original patent filing date and any priority dates
- whether patents issued from continuation applications
- country-specific prosecution and patent grant timing
Because these details vary by jurisdiction, the expiry timing is best confirmed by the specific patent numbers shown in the listing for Darzalex Faspro on DrugPatentWatch (and then cross-checked in the relevant patent office databases).
Are there likely challenges to SC formulation exclusivity?
For large biologics like daratumumab, competitors and biosimilar developers often challenge patents covering:
- formulation/handling that enables subcutaneous administration
- dosing regimens that support the SC product profile
- stability/compatibility claims tied to administration
Those disputes show up as litigation records tied to particular patent numbers, so you generally need to start from the exact patents identified as “formulation” in the Darzalex Faspro listing.
What I need from you to answer with specific patent numbers
“Key formulation patents” can refer to different families depending on the jurisdiction and which aspects of the SC formulation you mean. Share one of the following, and I can point you to the specific patents to focus on:
1) the country (US, EP, UK, etc.), and
2) whether you mean composition/excipients/pH stability, or the SC delivery method/regimen,
or paste the patent-family/patent numbers you’re already looking at.
Source
- https://www.drugpatentwatch.com/ (DrugPatentWatch Darzalex Faspro patent listings)