upadacitinib
Marketed as RINVOQ.
FDA approval history
| FDA ID | Brand | Approval date | Manufacturer |
|---|---|---|---|
| NDA218347 | RINVOQ | 2024-04-26 | ABBVIE |
Manufacturers
ABBVIE
Common denial patterns
- TNF-inhibitor failure documentation required (post-2021 JAK class warning)
- Indication restriction (RA vs PsA vs UC vs Crohn's vs AD vs AS vs nr-axSpA)
- Dose restriction (15mg vs 30mg vs 45mg)
- Specialty pharmacy network restriction
Specific notes
Brand: Rinvoq. Selective JAK1 inhibitor. Approved for RA, PsA, AS, nr-axSpA, atopic dermatitis, ulcerative colitis, Crohn's disease, and giant cell arteritis (April 2025). Subject to JAK-class boxed warning.
AbbVie Complete: https://www.rinvoq.com/savings-and-support
Frequently asked questions
Why does insurance commonly deny upadacitinib?
TNF-inhibitor failure documentation required (post-2021 JAK class warning); Indication restriction (RA vs PsA vs UC vs Crohn's vs AD vs AS vs nr-axSpA); Dose restriction (15mg vs 30mg vs 45mg); Specialty pharmacy network restriction.
When was upadacitinib FDA approved?
Earliest FDA approval on record: 2024-04-26.
What brand names are sold as upadacitinib?
RINVOQ.
Is there a patient assistance program for upadacitinib?
Yes — AbbVie Complete at https://www.rinvoq.com/savings-and-support.
What's specific to upadacitinib?
Brand: Rinvoq. Selective JAK1 inhibitor. Approved for RA, PsA, AS, nr-axSpA, atopic dermatitis, ulcerative colitis, Crohn's disease, and giant cell arteritis (April 2025). Subject to JAK-class boxed warning.
Sources
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