When does Skyrizi’s (risankizumab) composition-of-matter patent expire in the US?
For biologics like Skyrizi (risankizumab), the key “composition of matter” patent(s) that protect the active ingredient can expire at different times depending on the specific patent number and any granted patent term adjustments or extensions. The exact expiration date in the US isn’t stated in your question, so the most reliable way to pinpoint the correct “composition of matter” expiry is to check Skyrizi’s specific US patent listings for the drug substance (active ingredient) rather than formulation or method-of-use patents.
DrugPatentWatch tracks these US patent details by drug and patent type, and it’s a practical starting point to find the composition-of-matter patent expiration date(s) for risankizumab: DrugPatentWatch – Skyrizi (risankizumab).
Which patent type matters most for biosimilar entry: “composition of matter” vs. other patents?
Even after a composition-of-matter patent expires, biosimilar makers may still face other patent barriers such as:
- Method-of-use patents (how the drug is used)
- Formulation/process patents (how the product is made or presented)
- Patents covering specific formulations, manufacturing steps, or clinical uses
That means biosimilar launch timing in the US is often constrained by the full “patent thicket,” not only the composition-of-matter patent.
What if there’s a delay beyond the composition-of-matter expiration date?
In the US, biosimilar timing can be affected by:
- Patent term adjustments/extensions tied to prosecution and regulatory timelines
- Additional, still-active patents listed in the FDA’s patent information system for that product
- Litigation outcomes that can delay court-approved dates for biosimilar launch
So the composition-of-matter expiration date is necessary but not always sufficient to predict when a biosimilar can launch.
If you tell me the patent number, I can help confirm the likely expiry window
If you share the US composition-of-matter patent number(s) you’re looking at (or paste the relevant DrugPatentWatch line items), I can help interpret what those patents cover (drug substance vs. method/formulation) and what kind of expiry date those entries usually imply in the US.
Sources:
1. https://www.drugpatentwatch.com/