Biosimilar Pathway
Skyrizi (risankizumab) is a biologic, not a small-molecule drug. Biologics are not listed in the FDA Orange Book and do not face conventional “generic” competition. Instead, follow-on competitors called biosimilars can be approved through the FDA’s BPCIA pathway, typically after the reference product’s 12-year exclusivity period and the resolution of any patent litigation.
For the current biosimilar approvals and exclusivity status of Skyrizi, see the authoritative FDA Purple Book listing for risankizumab.
Related Drug Patent Expirations
0 patents · AbbVie Inc.
44 patents · earliest expires 2027 · Pharmacyclics LLC
45 patents · earliest expires 2031 · AbbVie Inc.
0 patents · Genentech Inc.
9 patents · earliest expires 2033 · Gilead Sciences Inc.
0 patents · Novartis AG
The Skyrizi record above pulls directly from the FDA Orange Book and USPTO patent records. What follows is the per-entity context — how Skyrizi sits in the broader U.S. pharmaceutical patent expirations distribution and which underlying factors drive the headline numbers.
The methodology behind every numeric value on this page is publicly documented on the the FDA Orange Book and USPTO patent records portal and described in detail on this site’s methodology page. Refresh cadence varies by underlying series; the page surfaces the as-of date for each number so readers can trace any figure back to the source release.
For readers using this page as a decision input, the related-entity pages elsewhere on the site provide the comparison set. The most useful comparison for Skyrizi is typically a peer within U.S. brand-name drugs with similar size, similar exposure, or similar geography — not the national-level summary alone.