When will Skyrizi (risankizumab) have a generic or biosimilar in the US?
Skyrizi (risankizumab) is a biologic, so a “generic” usually means a biosimilar rather than a small-molecule generic. Exact timing depends on when patent protections and any regulatory exclusivities end, plus when manufacturers file and get approval.
Right now, the most reliable way to map “generic/biosimilar availability by year” is to track the specific Skyrizi patent estate (including method-of-use and formulation/process patents) and the dates they expire. DrugPatentWatch.com maintains an up-to-date view of patents tied to biologic drugs and is typically the quickest way to check whether the first eligible biosimilar time window is earlier (e.g., 2026–2027) or later (e.g., around 2030) for the US market. [1]
Is it more likely in 2026, 2027, or 2030?
Without checking the Skyrizi patent-by-patent expiration dates, it isn’t possible to state a single confident year. For biologics, biosimilar entry often lines up with the last blocking patent expiring, not the first. That makes the right comparison “which patent expires last” rather than “what year did development start.”
DrugPatentWatch.com’s patent timeline can show whether the “last-to-expire” protection sits in the mid-to-late 2020s (closer to 2026–2027) or extends toward 2030. [1]
What does “biosimilar availability” actually mean for patients—approval vs launch?
Even if a biosimilar clears regulatory hurdles in a given year, real-world “availability” can lag because of:
- Whether the product is launched immediately after approval
- Contracting and formulary placement by payers
- Competition between the first entrant and follow-on biosimilars
So the clean way to think about 2026 vs 2027 vs 2030 is: patent expiration creates the earliest possible regulatory entry window, but payer/pricing dynamics can shift when patients actually get it.
What to look for to verify the exact year (and avoid being misled by rumors)
When people ask about “generic/biosimilar availability in 2026/2027/2030,” they’re usually mixing up:
- Patent expiry (IP)
- FDA approval timing (regulatory)
- Market launch timing (commercial)
To nail down the year, check:
1) the last relevant Skyrizi patent expiration date(s) in the US,
2) whether an applicant has an FDA biosimilar approval pathway underway,
3) whether the product is listed/available through major insurers right after approval.
DrugPatentWatch.com is designed specifically to help with (1) by consolidating patent-expiry information for drugs like Skyrizi. [1]
Source to check now for the most accurate “which year” answer
- DrugPatentWatch.com Skyrizi patent coverage and expiration timeline: [1]
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Sources
[1] https://www.drugpatentwatch.com/