How many Rinvoq biosimilars are approved?

Drug Landscape tracks 1 approved Rinvoq biosimilars across global regulators. 0 additional applications are filed and 2 are in Phase 3.

Is Rinvoq still patent-protected?

All tracked patents on Rinvoq have expired in tracked territories.

What is a biosimilar?

A biosimilar is a biological medicine highly similar to an already-approved reference biologic (the originator), with no clinically meaningful differences in safety, purity, or potency. Approved via abbreviated regulatory pathways once the originator's data exclusivity and patents expire.

Last reviewed 2026-06-10 · How we verify

Rinvoq biosimilars

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Complete Rinvoq (upadacitinib) biosimilar landscape: 1 approved biosimilars, 0 filed, 2 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

1 approved 0 filed 2 Phase 3 All key patents expired

About Rinvoq

Rinvoq (upadacitinib) — originally marketed by AbbVie Inc.. Class: JAK inhibitor. Target: Janus kinase (JAK) enzymes, particularly JAK1 and JAK2. Area: Immunology.

Approved biosimilars (1)

Biosimilar	Sponsor	Phase	First approval	Country
UPADACITINIB HEMIHYDRATE		marketed	2019-01-01

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (2)

Biosimilar	Sponsor	Phase	First approval	Country
Upadacitinib Oral Product	McMaster University	phase 3
Upadacitinib (ABT-494)	AbbVie	phase 3

Originator patent timeline

Active patents (0)

No active patents tracked.

Expired patents (0)

No expired patents tracked.

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Every regulatory action on Rinvoq or any of its biosimilars:

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing