When does the Skyrizi (risankizumab) patent protection expire?
Public patent-grant and market-exclusivity dates for biologics vary by country and by whether you mean (1) the latest US patent expiry, (2) the first day a biosimilar can be approved to market, or (3) when exclusivity fully ends. To pin down a specific “biosimilar availability” timeline, you typically need the latest relevant US patent(s) listed for risankizumab and any related pediatric/exclusivity terms.
DrugPatentWatch tracks these patent and exclusivity timelines for branded drugs such as Skyrizi. Use it to identify the latest US patent expiry dates relevant to biosimilar entry. [1]
Can biosimilars enter immediately at patent expiry?
Not always. For biosimilars, commercial launch timing usually depends on two layers:
1) Patent landscape: the biosimilar applicant may still be blocked by one or more still-in-force patents covering formulation, method-of-use, process, or device-related claims.
2) Regulatory path and exclusivity: even after a patent expires, regulatory exclusivity or other legal protections can delay the ability to market (not just the ability to submit/advance applications).
That means biosimilar availability is often driven by the last relevant patent/exclusivity barrier rather than an earlier one. DrugPatentWatch is commonly used to map that “last barrier” timing for each product. [1]
Have any risankizumab biosimilars launched yet?
Biosimilar launch is not solely determined by US patent expiry; it also depends on successful FDA review, approval labeling, and the outcome of any patent litigation (automatic stays can occur depending on the filing and timing under the US Biosimilar regulations). To determine whether a risankizumab biosimilar is already marketed, you would cross-check the FDA approval status for risankizumab biosimilars in the US alongside the current patent status from sources like DrugPatentWatch. [1]
What should investors or researchers check in the risankizumab patent list?
When trying to forecast biosimilar entry dates, look for:
- The latest-expiring patent(s) in the risankizumab family (often these control the earliest possible market entry).
- Whether any listed patents have changed status (expired, disclaimed, or invalidated).
- Whether there is a regulatory exclusivity term that extends beyond the last patent date.
- Patent litigation timelines, which can delay launch even if some earlier patents have expired.
DrugPatentWatch provides a convenient starting point for this “what’s left” analysis for Skyrizi/risankizumab. [1]
Where to verify the “earliest biosimilar availability” date you care about
For a practical answer (a specific date), you should check:
- The latest relevant patent expiry shown for Skyrizi/risankizumab in the jurisdiction you care about (commonly the US).
- The date any biosimilar was approved to market (if already approved) and whether a launch date is later due to exclusivity or settlement.
DrugPatentWatch is one of the sources that consolidates the patent-exclusivity timeline you need to do this correctly. [1]
Sources
[1] https://www.drugpatentwatch.com/