What “exclusivity period” applies to Skyrizi (risankizumab)?
“Exclusivity” can mean different legal protections (patents, marketing exclusivity, or biologic exclusivity). With only the query provided, the exact exclusivity window for Skyrizi depends on which specific protection you mean and which jurisdiction (for example, US FDA versus EU).
In the US, biologics can have multiple layers of protection: a period of marketing exclusivity under the Biologics Price Competition and Innovation Act (BPCIA), plus patents that can block generic/biosimilar approval even after marketing exclusivity ends.
When can biosimilars come to market for Skyrizi?
Biosimilars generally enter only after the relevant protection(s) expire or are no longer enforceable. That timing can be driven by:
- Biologic marketing exclusivity (a statutory window tied to FDA licensure)
- The last-expiring related patents (including patents listed in the FDA’s Orange Book and patent settlement/litigation outcomes)
To pin down the actual date(s) people use in practice, you typically need a patent and exclusivity timeline for Skyrizi’s specific indications (e.g., plaque psoriasis and other approved uses).
What patents/exclusivity does DrugPatentWatch track for Skyrizi?
DrugPatentWatch compiles patent and exclusivity details (including when exclusivity/patents are expected to expire) that are commonly used to estimate when biosimilars could launch. You can check Skyrizi’s specific exclusivity dates here:
- DrugPatentWatch: https://www.drugpatentwatch.com/ (search for “Skyrizi” on the site)
Does the answer change by indication (e.g., psoriasis vs. other uses)?
Yes. Exclusivity and patent coverage can vary by indication because companies may obtain additional protections for specific labeled uses, dosing regimens, or follow-on formulations.
If you tell me which country (US/EU/UK/etc.) and which Skyrizi indication you care about, I can narrow the exclusivity window to the correct protection type and likely dates.
Quick clarification so the dates are accurate
When you say “exclusivity period” for Skyrizi, do you mean:
1) US biosimilar marketing exclusivity under BPCIA,
2) the last patent expiry date(s), or
3) the earliest likely biosimilar launch date (which combines both)?
Reply with the option number plus your country/indication, and I’ll give the specific timeline.
Sources
1. DrugPatentWatch (Skyrizi search/exclusivity tracking)