Is Linagliptin + Metformin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 7 valid registrations of Linagliptin + Metformin, including Lijen Met (2.5,850 mg,mg, Film-coated tablet, SAR 137.00); Lijen Met (2.5,1000 mg,mg, Film-coated tablet, SAR 145.45); OLPUNTRA MET (2.5,1000 mg,mg, Film-coated tablet, SAR 78.05); OLPUNTRA MET (2.5,850 mg,mg, Film-coated tablet, SAR 78.05); Zylinamet (2.5,1000 mg,mg, Film-coated tablet, SAR 142.90).

Is Linagliptin + Metformin approved by the US FDA?

Drugs@FDA lists 6 application product lines for Linagliptin + Metformin, including JENTADUETO (Prescription); JENTADUETO XR (Prescription); LINAGLIPTIN AND METFORMIN HYDROCHLORIDE (Prescription); LINAGLIPTIN AND METFORMIN HYDROCHLORIDE (Prescription); LINAGLIPTIN AND METFORMIN HYDROCHLORIDE (Prescription).

Is Linagliptin + Metformin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Linagliptin + Metformin: Jentadueto.

Active substances

Linagliptin + Metformin

SFDA 7
US FDA 6
EMA 1
Health Canada 3
US price lines 5
NHS prices 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Lijen Met	2.5,850 mg,mg	Film-coated tablet · Oral use	60 Bottle	SAR 137.00	Generic · Prescription	Med City Pharma	Valid
Lijen Met	2.5,1000 mg,mg	Film-coated tablet · Oral use	60 Bottle	SAR 145.45	Generic · Prescription	Med City Pharma	Valid
OLPUNTRA MET	2.5,1000 mg,mg	Film-coated tablet · Oral use	60 Blister	SAR 78.05	NCE · Prescription	ALPHA PHARMA INDUSTRY	Valid
OLPUNTRA MET	2.5,850 mg,mg	Film-coated tablet · Oral use	60 Blister	SAR 78.05	NCE · Prescription	ALPHA PHARMA INDUSTRY	Valid
Zylinamet	2.5,1000 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 142.90	Generic · Prescription	Alrai Pharmaceutical industry Co. (L.L.C)	Valid
Zylinamet	2.5,850 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 134.60	Generic · Prescription	Alrai Pharmaceutical industry Co. (L.L.C)	Valid
Zylinamet	2.5,500 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 124.35	Generic · Prescription	Alrai Pharmaceutical industry Co. (L.L.C)	Valid

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
JENTADUETO	2.5MG;500MG; 2.5MG;850MG; 2.5MG;1GM	tablet · oral	BOEHRINGER INGELHEIM	Prescription	30 Jan 2012
JENTADUETO XR	2.5MG;1GM; 5MG;1GM	tablet, extended release · oral	BOEHRINGER INGELHEIM	Prescription	27 May 2016
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	2.5MG;500MG; 2.5MG;850MG; 2.5MG;1GM	tablet · oral	SUNSHINE	Prescription	30 Aug 2021
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	2.5MG;500MG; 2.5MG;850MG; 2.5MG;1GM	tablet · oral	ZYDUS PHARMS	Prescription	30 Mar 2023
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	2.5MG;500MG; 2.5MG;850MG; 2.5MG;1GM	tablet · oral	DR REDDYS	Prescription	3 Nov 2025
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	2.5MG;500MG; 2.5MG;850MG; 2.5MG;1GM	tablet · oral	MSN	Prescription	3 Nov 2025

EMA European Union — centrally authorised medicines

Jentadueto Boehringer Ingelheim International GmbH · Authorised · authorised 19 Jul 2012 · ATC A10BD11

Therapeutic indication (EMA)

Treatment of adult patients with type-2 diabetes mellitus: Jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin. Jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
JENTADUETO	02403250	500 MG; 2.5 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE
JENTADUETO	02403269	850 MG; 2.5 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE
JENTADUETO	02403277	1000 MG; 2.5 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	JENTADUETO 2.5 MG-1,000 MG TAB	$8.4388	per EA	23 Sep 2026
US NADAC	JENTADUETO 2.5 MG-500 MG TAB	$8.44289	per EA	23 Sep 2026
US NADAC	JENTADUETO 2.5 MG-850 MG TAB	$8.45431	per EA	23 Sep 2026
US NADAC	JENTADUETO XR 2.5 MG-1,000 MG	$8.46945	per EA	23 Sep 2026
US NADAC	JENTADUETO XR 5 MG-1,000 MG TB	$16.94698	per EA	23 Sep 2026
NHS Drug Tariff	Linagliptin 2.5mg / Metformin 1g tablets	£33.26	56 tablet	1 Oct 2026
NHS Drug Tariff	Linagliptin 2.5mg / Metformin 850mg tablets	£33.26	56 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.