How many Ozempic biosimilars are approved?

Drug Landscape tracks 14 approved Ozempic biosimilars across global regulators. 0 additional applications are filed and 4 are in Phase 3.

Is Ozempic still patent-protected?

19 active patents remain on Ozempic. Earliest expiry: 2026-07-17.

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

Ozempic biosimilars

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

Complete Ozempic (semaglutide) biosimilar landscape: 14 approved biosimilars, 0 filed, 4 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

14 approved 0 filed 4 Phase 3 19 active patents

About Ozempic

Ozempic (semaglutide) — originally marketed by Novo Nordisk. Class: GLP-1 Receptor Agonist [EPC]. Target: GLP-1 receptor. Area: Metabolic. First approved 2017-01-01.

Approved biosimilars (14)

Biosimilar	Sponsor	Phase	First approval
SEMAGLUTIDE		marketed	2017-01-01
Semaglutide Auto-Injector	University of Washington	marketed
semaglutide combined with metformin	The First Affiliated Hospital of Xiamen University	marketed
Semaglutide 2.4 mg	Novo Nordisk A/S	marketed
Semaglutide 1.0 mg	Novo Nordisk A/S	marketed
Semaglutide Pen	Unity Health Toronto	marketed
Semaglutide Pill	Medanta, The Medicity, India	marketed
Semaglutide Pen Injector [Ozempic]	University of Nottingham	marketed
Semaglutide Injectable Product	Neurogastrx, Inc.	marketed
semaglutide or tirzepatide	Mayo Clinic	marketed
Semaglutide, Empagliflozin	University Medical Center, Kazakhstan	marketed
Semaglutide Pen Injector	University of Pennsylvania	marketed
Semaglutide (Rybelsus®)	Instituto Mexicano del Seguro Social	marketed
Semaglutide Treatment	University Health Network, Toronto	marketed

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (4)

Biosimilar	Sponsor	Phase
Semaglutide(Wegovy® )	Gan & Lee Pharmaceuticals.	phase 3
Semaglutide J	Novo Nordisk A/S	phase 3
semaglutide injection (HD1916)	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	phase 3
Semaglutide B	Novo Nordisk A/S	phase 3

Originator patent timeline

Active patents (19)

2041-02-17 — 11318191 · US
2038-08-24 — 10888605 · US
2034-05-02 — 10278923 · US
2033-06-21 — 10335462 · US
2033-06-21 — 9764003 · US
2033-03-15 — 10933120 · US
2032-02-01 — 9132239 · US
2031-12-16 — 10086047 · US
2031-12-16 — 9278123 · US
2031-12-16 — 11382957 · US
2031-12-16 — 10960052 · US
2031-12-05 — 8129343 · US

Expired patents (1)

2026-03-20 — 8536122 · US

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Every regulatory action on Ozempic or any of its biosimilars:

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