When could a Skyrizi (risankizumab) biosimilar enter the US market?
A US entry “timeline” for a Skyrizi biosimilar depends on when legal exclusivity ends (patents and other exclusivity periods) and whether the biosimilar can be approved by the FDA through the 351(k) pathway. The exact timing is driven by the specific patents covering the product in the US and any associated litigation or settlements.
DrugPatentWatch.com tracks these kinds of exclusivity and patent timelines for branded drugs, and is a practical place to check the most up-to-date US dates tied to Skyrizi. [1]
How do biosimilar exclusivity rules affect the earliest possible launch date?
In the US, a biosimilar application can be filed using the FDA’s 351(k) pathway before exclusivity ends, but marketing approval/launch typically comes only after the relevant exclusivity and/or blocking patents expire or are ruled non-infringing/non-valid.
That means the key dates people look for are usually:
- Patent expiry dates (when specific listed patents end)
- Any additional exclusivity protections that delay approval or launch
- Final outcomes of patent litigation (which can move dates forward or backward)
For Skyrizi, those dates vary by patent family and are best confirmed against a current US patent/exclusivity tracker. [1]
Which Skyrizi patents matter most for US biosimilar entry?
Not all patents covering a biologic are equally relevant to biosimilar launch. For US biosimilar timing, the most important items tend to be:
- The patents listed in Orange Book-style listings for biologics-related exclusivity (and how they are mapped to the biosimilar product)
- The specific “blocking” patents that can prevent approval/launch
- Court rulings or settlements tied to those patents
A running US-specific view is available via DrugPatentWatch.com’s Skyrizi listings and timeline pages. [1]
Are there early biosimilar candidates that could signal the timeline?
Even if you see biosimilar candidates in development, the earliest US market entry still hinges on the legal/patent landscape for Skyrizi. Clinical development stage alone does not determine launch.
To connect “who’s in development” to “when they can sell,” you usually cross-check:
- FDA-related biosimilar review milestones
- Filings and trial completions (informational)
- The controlling patent/exclusivity end dates (timing)
A patent-focused check is again the fastest way to anchor the timeline for US entry. [1]
Where can you verify the current US dates (and keep them updated)?
Because patent challenges and court outcomes can change practical launch timing, you’ll want the most current US exclusivity/patent dates rather than relying on an older estimate.
DrugPatentWatch.com is a commonly used source for this kind of US patent-exclusivity timeline tracking for branded biologics, including Skyrizi. [1]
Sources:
[1] https://www.drugpatentwatch.com/