Upadacitinib manufacturers

About upadacitinib

Upadacitinib manufacturers are currently limited to the originator, AbbVie, which sells it as Rinvoq. Upadacitinib is an oral, selective Janus kinase 1 (JAK1) inhibitor for immune-mediated inflammatory diseases. It is approved for rheumatoid arthritis, psoriatic arthritis, spondyloarthritis, atopic dermatitis, ulcerative colitis, Crohn's disease and giant cell arteritis. Under patent settlements, no US generic is expected before April 2037. Pharmaceutical companies can prepare upadacitinib dossiers for markets where patents allow.

Upadacitinib key facts

Upadacitinib manufacturers and licensing history

AbbVie developed upadacitinib, and the FDA approved Rinvoq in August 2019 for rheumatoid arthritis. Approvals have since expanded to psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, atopic dermatitis, ulcerative colitis, Crohn's disease, juvenile idiopathic arthritis and giant cell arteritis. AbbVie is also studying it in alopecia areata, vitiligo, hidradenitis suppurativa and lupus.

Rinvoq is one of AbbVie's two main growth drugs, alongside Skyrizi, following the loss of exclusivity for Humira. Sales grew by more than 48% in the first half of 2025, to about USD 3.75 billion.

AbbVie sued generic applicants, including Sandoz, Hetero, Aurobindo, Intas and Sun Pharma, in 2023. In September 2025, it settled with all of them, and no US generic is expected before April 2037, assuming paediatric exclusivity is granted. Buyers should confirm API crystal form, extended-release formulation capability and freedom to operate before choosing a dossier partner.

Upadacitinib dosage forms and dossier types

Upadacitinib is approved as extended-release tablets and as an oral solution for children.

Upadacitinib regulatory and patent status

The FDA approved upadacitinib in August 2019, and the EU in December 2019. Its US compound patent expires in 2033, with other Orange Book patents listed to 2038. Under September 2025 settlements with all generic applicants, no US generic is expected before April 2037, assuming paediatric exclusivity is granted. Like other JAK inhibitors, it carries a boxed warning.

Upadacitinib mechanism of action and therapeutic use

Upadacitinib selectively blocks JAK1, an enzyme that transmits signals from several inflammatory cytokines. This reduces inflammation in joints, skin and the gut. It is taken once daily as a tablet and used for rheumatoid arthritis, psoriatic arthritis, spondyloarthritis, atopic dermatitis, ulcerative colitis, Crohn's disease and giant cell arteritis, usually after other treatments have not worked well enough.

Upadacitinib licensing and sourcing

Upadacitinib is currently available only from AbbVie. Companies interested in this molecule usually prepare future generic dossiers or API supply for markets where patents allow. Current offers and supplier contacts are listed among the upadacitinib manufacturers on Pipelinepharma.

Frequently asked questions about upadacitinib

Who manufactures upadacitinib? AbbVie is the only manufacturer and sells upadacitinib as Rinvoq.

When can generic upadacitinib launch in the US? Under September 2025 settlements, no US generic is expected before April 2037, assuming paediatric exclusivity is granted.

What is upadacitinib used for? Upadacitinib is used for rheumatoid arthritis, psoriatic arthritis, spondyloarthritis, atopic dermatitis, ulcerative colitis, Crohn's disease, juvenile idiopathic arthritis and giant cell arteritis.

What forms and strengths of upadacitinib are available? Upadacitinib is available as 15, 30 and 45 mg extended-release tablets and as a 1 mg/ml oral solution.

What safety warnings apply to upadacitinib? Like other JAK inhibitors, upadacitinib has a boxed warning for serious infections, mortality, cancer, major cardiovascular events and blood clots.