How many Xarelto biosimilars are approved?

Drug Landscape tracks 15 approved Xarelto biosimilars across global regulators. 0 additional applications are filed and 3 are in Phase 3.

Is Xarelto still patent-protected?

2 active patents remain on Xarelto. Earliest expiry: 2034-02-17.

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

Xarelto biosimilars

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

Complete Xarelto (rivaroxaban) biosimilar landscape: 15 approved biosimilars, 0 filed, 3 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

15 approved 0 filed 3 Phase 3 2 active patents

About Xarelto

Xarelto (rivaroxaban) — originally marketed by Johnson & Johnson. Class: Direct Factor Xa Inhibitor. Target: Factor Xa (FXa). Area: Oncology. First approved 2011-01-01.

Approved biosimilars (15)

Biosimilar	Sponsor	Phase	First approval
RIVAROXABAN		marketed	2008-01-01
Rivaroxaban, Ticagrelor, ASA	Medical University of Vienna	marketed
Rivaroxaban (Xarelto)	University of Michigan	marketed
Rivaroxaban or Warfarin	Fujita Health University	marketed
Rivaroxaban Oral Tablet	Swiss Paraplegic Research, Nottwil	marketed
Rivaroxaban or Marcumar	RWTH Aachen University	marketed
Rivaroxaban, Dabigatran	University Hospital, Grenoble	marketed
Rivaroxaban 10 milligram Oral Tablet	Florida Orthopaedic Institute	marketed
Rivaroxaban 10 mg	Hospital Alemão Oswaldo Cruz	marketed
Rivaroxaban Oral Tablet [Xarelto]	Children's Hospital of Fudan University	marketed
Rivaroxaban, dabigatran, apixaban, or edoxaban	Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec	marketed
Rivaroxaban 2.5mg	Asan Medical Center	marketed
Rivaroxaban and aspirin 80	Shiraz University of Medical Sciences	marketed
rivaroxaban and ticagrel therapy	Beijing Anzhen Hospital	marketed
rivaroxaban (10mg)	Chang Gung Memorial Hospital	marketed

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (3)

Biosimilar	Sponsor	Phase
Rivaroxaban (BAY59-7939)	Bayer	phase 3
Rivaroxaban + Aspirin	University of Florida	phase 3
Rivaroxaban 10 Milligrams	Ahmed AbdelMoneim Hassan Ali	phase 3

Originator patent timeline

Active patents (2)

2034-08-17 — 9539218*PED · Compound · US
2034-02-17 — 9539218 · Method of Use · US

Expired patents (0)

No expired patents tracked.

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Every regulatory action on Xarelto or any of its biosimilars:

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