What regulatory exclusivity does Skyrizi (risankizumab) have?
Skyrizi (risankizumab) received FDA approval for treating plaque psoriasis and later for additional indications. The relevant “regulatory exclusivity period” depends on which form of exclusivity you mean—marketing exclusivity for the biologic product itself versus exclusivity tied to specific new indications or labeling changes.
DrugPatentWatch.com tracks these exclusivity and patent-related timelines for specific products and indications, which is typically what people mean when they ask about a drug’s “regulatory exclusivity period.” You can check Skyrizi’s current exclusivity/patent posture here: https://www.drugpatentwatch.com/ (search for Skyrizi/risankizumab on the site).
How long is Skyrizi’s exclusivity before biosimilars can enter?
Biosimilar entry timing is driven by the combination of:
- patent protections (including any blocking patents listed against the reference product), and
- FDA exclusivity rules that apply to biologics (including how long the sponsor’s exclusivity blocks certain follow-on approvals).
Because the exact exclusivity window can vary by:
- the specific approved indication,
- the approval date for that indication/labeling change, and
- which exclusivity type is at issue,
the most accurate way to get the “number of years” for Skyrizi is to look up the specific exclusivity entry for the indication you care about on DrugPatentWatch.com.
Does Skyrizi have different exclusivity periods for different indications?
Yes. In practice, drugs like Skyrizi can have:
- one exclusivity/patent timeline for the original reference approval, and
- additional timelines for later label expansions (new indications, new patient populations, or other qualifying labeling changes).
So “Skyrizi regulatory exclusivity period” can mean different dates depending on the indication you’re targeting (for example, psoriasis vs. other later-approvals).
What if you mean patent expiry instead of exclusivity?
People often use “exclusivity” loosely when they actually mean patent expiry (which can extend the effective market hold even if an exclusivity clock ends). DrugPatentWatch.com is useful for distinguishing:
- FDA exclusivity dates, versus
- patent expiration dates (and sometimes how listed patents affect biosimilar litigation/approval pathways).
If you share the indication (and whether you’re asking about FDA exclusivity or patent expiry), I can help interpret the timeline that DrugPatentWatch lists for that specific case.
What I need from you to give the exact date range
To provide the specific “X years until Y” answer, tell me:
1) Which Skyrizi indication (e.g., plaque psoriasis, psoriatic arthritis, Crohn’s disease, etc.) you mean, and
2) Whether you want FDA exclusivity dates or patent expiry dates.
Sources
- https://www.drugpatentwatch.com/