How many Farxiga biosimilars are approved?

Drug Landscape tracks 14 approved Farxiga biosimilars across global regulators. 0 additional applications are filed and 3 are in Phase 3.

Is Farxiga still patent-protected?

All tracked patents on Farxiga 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

Farxiga biosimilars

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

Complete Farxiga (DAPAGLIFLOZIN) biosimilar landscape: 14 approved biosimilars, 0 filed, 3 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

14 approved 0 filed 3 Phase 3 All key patents expired

About Farxiga

Farxiga (DAPAGLIFLOZIN) — originally marketed by AstraZeneca. Class: Sodium-Glucose Cotransporter 2 Inhibitor. Target: Sodium/glucose cotransporter 2. Area: Immunology. First approved 2014-01-01.

Approved biosimilars (14)

Biosimilar	Sponsor	Phase
DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE	LUPIN LTD	marketed
Dapagliflozin Oral Product	Vastra Gotaland Region	marketed
Dapagliflozin + Lobeglitazone	Seoul National University Bundang Hospital	marketed
dapagliflozin and saxagliptin	AstraZeneca	marketed
Dapagliflozin 10mg	LG Chem	marketed
Dapagliflozin plus Metformin XR	University of Guadalajara	marketed
Dapagliflozin or Empagliflozin	Yonsei University	marketed
Dapagliflozin (DAPA)	Ottawa Heart Institute Research Corporation	marketed
Dapagliflozin/Sitagliptin	Boryung Pharmaceutical Co., Ltd	marketed
Dapagliflozin / metFORMIN Pill	Tan Tock Seng Hospital	marketed
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	AUROBINDO PHARMA LIMITED	marketed
Dapagliflozin/Pioglitazone	Boryung Pharmaceutical Co., Ltd	marketed
Dapagliflozin+ACEI treatment	Children's Hospital of Fudan University	marketed
Dapagliflozin (Forxiga)	National Institute of Cardiology, Warsaw, Poland	marketed

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (3)

Biosimilar	Sponsor	Phase
Dapagliflozin Farxiga®	October 6 University	phase 3
Dapagliflozin/Metformin	AstraZeneca	phase 3
Dapagliflozin Pill	Centro Universitario de Ciencias de la Salud, Mexico	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 Farxiga or any of its biosimilars:

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