How many Jardiance biosimilars are approved?

Drug Landscape tracks 13 approved Jardiance biosimilars across global regulators. 0 additional applications are filed and 2 are in Phase 3.

Is Jardiance still patent-protected?

All tracked patents on Jardiance 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

Jardiance biosimilars

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

Complete Jardiance (empagliflozin) biosimilar landscape: 13 approved biosimilars, 0 filed, 2 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

13 approved 0 filed 2 Phase 3 All key patents expired

About Jardiance

Jardiance (empagliflozin) — originally marketed by Boehringer Ingelheim. Class: Sodium-Glucose Cotransporter 2 Inhibitor [EPC]. Target: SGLT2. Area: Metabolic. First approved 2014-01-01.

Approved biosimilars (13)

Biosimilar	Sponsor	Phase	First approval
Synjardy	Hotel Dieu de France Hospital	marketed	2015-01-01
Empagliflozin Arm	University of Alabama at Birmingham	marketed
Empagliflozin 25mg	Samuel Lunenfeld Research Institute, Mount Sinai Hospital	marketed
Empagliflozin Oral Tablet [Jardiance]	Royal Perth Hospital	marketed
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	AJANTA PHARMA LTD	marketed
empagliflozin 10mg	Chong Kun Dang Pharmaceutical	marketed
Empagliflozin (EMPA)	University of Sao Paulo	marketed
Empagliflozin and Linagliptin	Institut für Pharmakologie und Präventive Medizin	marketed
Empagliflozin (Jardiance®)	University Hospital Tuebingen	marketed
Empagliflozin + Carvedilol	Post Graduate Institute of Medical Education and Research, Chandigarh	marketed
Empagliflozin and Dulaglutide	Seoul National University Bundang Hospital	marketed
Empagliflozin Tablets	Kobe University	marketed
Empagliflozin 10 MG	Tanta University	marketed

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (2)

Biosimilar	Sponsor	Phase	First approval	Country
Empagliflozin Pill	Centro Universitario de Ciencias de la Salud, Mexico	phase 3
Empagliflozin 10 milligram	Ain Shams University	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 Jardiance or any of its biosimilars:

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