Regulatory PathRegulatory requirements compared

Active substance

Sitagliptin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Balivio100 mgFilm-coated tablet · Oral use28 BlisterSAR 84.20Generic · PrescriptionHonessan PharmaValid
Balivio50 mgFilm-coated tablet · Oral use28 BlisterSAR 45.00Generic · PrescriptionHonessan PharmaValid
Balivio25 mgFilm-coated tablet · Oral use28 BlisterSAR 24.55Generic · PrescriptionHonessan PharmaValid
Cronoxam100 mgFilm-coated tablet · Oral use28 BlisterSAR 81.95Generic · PrescriptionAPOTEXValid
GLIPTEN 100MG F.C. TABLET100 mgFilm-coated tablet · Oral use28 BlisterSAR 98.20NCE · PrescriptionSPIMACO ADDWAEIHValid
Glyci100 mgFilm-coated tablet · Oral use30 BlisterSAR 87.80Generic · PrescriptionPharco International pharmaceutical companyValid
Glytix100 mgFilm-coated tablet · Oral use28 BlisterSAR 84.20Generic · PrescriptionMS Pharma Saudi (MSPS)Valid
Glytix50 mgFilm-coated tablet · Oral use28 BlisterSAR 45.00Generic · PrescriptionMS Pharma Saudi (MSPS)Valid
Glytix25 mgFilm-coated tablet · Oral use28 BlisterSAR 31.25Generic · PrescriptionMS Pharma Saudi (MSPS)Valid
JANUVIA 100MG F.C. TABLETS100 mgFilm-coated tablet · Oral use28 BlisterSAR 105.25NCE · PrescriptionMERCK SHARP & DOHMEValid
JANUVIA 25 mg25 mgFilm-coated tablet · Oral use28 BlisterSAR 44.65NCE · PrescriptionMERCK SHARP & DOHMEValid
JANUVIA 50 mg50 mgFilm-coated tablet · Oral use28 BlisterSAR 81.70NCE · PrescriptionMERCK SHARP & DOHMEValid
Juleen25 mgFilm-coated tablet · Oral use30 BlisterSAR 40.65Generic · PrescriptionSUDAIR PHARMA COMPANYValid
Juleen50 mgFilm-coated tablet · Oral use30 BlisterSAR 74.40Generic · PrescriptionSUDAIR PHARMA COMPANYValid
Juleen100 mgFilm-coated tablet · Oral use30 BlisterSAR 90.20Generic · PrescriptionSUDAIR PHARMA COMPANYValid
Maysiglu100Film-coated tablet · Oral use28 BlisterSAR 81.95Generic · PrescriptionKRKA D D NOVO MESTOValid
Meliglptin100 mgFilm-coated tablet · Oral use30 BlisterSAR 91.20Generic · PrescriptionSaudi AmaroxValid
Meliglptin50 mgFilm-coated tablet · Oral use30 BlisterSAR 45.60Generic · PrescriptionSaudi AmaroxValid
Meliglptin25 mgFilm-coated tablet · Oral use30 BlisterSAR 22.80Generic · PrescriptionSaudi AmaroxValid
SITAJUB100 mgTablet · Oral use30 BlisterSAR 90.20Generic · PrescriptionAlhobail PharmValid
SITAJUB50 mgFilm-coated tablet · Oral use30 BlisterSAR 48.20Generic · PrescriptionAlhobail PharmValid
SITAJUB25 mgFilm-coated tablet · Oral use30 BlisterSAR 40.65Generic · PrescriptionAlhobail PharmValid
SITAVIA50 mgFilm-coated tablet · Oral use30 BlisterSAR 74.40Generic · PrescriptionMiddle East Pharmaceutical Industries Co Ltd Avalon PharmaValid
SITAVIA100 mgFilm-coated tablet · Oral use30 BlisterSAR 90.20Generic · PrescriptionMiddle East Pharmaceutical Industries Co Ltd Avalon PharmaValid
Sita100 mgFilm-coated tablet · Oral use30 BlisterSAR 90.20Generic · PrescriptionAlrai Pharmaceutical industry Co. (L.L.C)Valid

9 more — full table

Indications — CHI Daman Drug Formulary

DIABETES MELLITUS TYPE 2

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

ProductStrengthForm · routeApplicantStatusFirst approved
JANUVIAEQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASEtablet · oralMSDPrescription16 Oct 2006
ZITUVIO25MG; 50MG; 100MGtablet · oralZYDUS LIFESCIENCESPrescription18 Oct 2023
BRYNOVINEQ 25MG BASE/MLsolution · oralAZURITYPrescription16 Jan 2025
SITAGLIPTIN PHOSPHATEEQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASEtablet · oralWATSON LABS INCPrescription29 Dec 2025
SITAGLIPTIN PHOSPHATEEQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASEtablet · oralSANDOZPrescription14 Jan 2026
SITAGLIPTIN PHOSPHATEEQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASEtablet · oralAPOTEXPrescription20 Jan 2026

EMA European Union — centrally authorised medicines

Januvia Merck Sharp and Dohme B.V · Authorised · authorised 20 Mar 2007 · ATC A10BH01

Therapeutic indication (EMA)

For adult patients with type-2 diabetes mellitus, Januvia is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance; a peroxisome-proliferator-activated-receptor-gamma (PPAR?) agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? agonist alone do not provide adequate glycaemic control; a PPAR? agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? agonist alone do not provide adequate glycaemic control; as triple oral therapy in combination with: a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control; a PPAR? agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Januvia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Xelevia Merck Sharp & Dohme B.V. · Authorised · authorised 21 Mar 2007 · ATC A10BH01

Therapeutic indication (EMA)

For adult patients with type-2 diabetes mellitus, Xelevia is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance; a peroxisome proliferator-activated receptor gamma (PPAR?) agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? agonist alone do not provide adequate glycaemic control; as triple oral therapy in combination with: a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control; a PPAR? agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Xelevia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Tesavel Merck Sharp & Dohme B.V. · Authorised · authorised 10 Jan 2008 · ATC A10BH01

Therapeutic indication (EMA)

For patients with type-2 diabetes mellitus, Tesavel is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance; a PPAR? agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? agonist alone do not provide adequate glycaemic control; as triple oral therapy in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control; a peroxisome-proliferator-activated-receptor-gamma (PPAR?) agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control. Tesavel is also indicated as add on to insulin (with or without metformin) when diet and exercise plus stable dosage of insulin do not provide adequate glycaemic control.

Ristaben Merck Sharp & Dohme B.V. · Authorised · authorised 15 Mar 2010 · ATC A10BH01

Therapeutic indication (EMA)

For adult patients with type-2 diabetes mellitus, Ristaben is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance; a peroxisome proliferator-activated-receptor-gamma (PPAR?) agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? agonist alone do not provide adequate glycaemic control; as triple oral therapy in combination with: a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control; a PPAR? agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Ristaben is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Sitagliptin SUN Sun Pharmaceutical Industries Europe B.V. · Authorised · authorised 9 Dec 2021 · ATC A10BH01

Therapeutic indication (EMA)

For adult patients with type 2 diabetes mellitus, Sitagliptin SUN is indicated to improve glycaemic control: as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.- a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.- a peroxisome proliferator-activated receptor gamma (PPAR?) agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.- a PPAR? agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Sitagliptin SUN is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Sitagliptin Accord Accord Healthcare S.L.U. · Authorised · authorised 25 Apr 2022 · ATC A10BH01

Therapeutic indication (EMA)

For adult patients with type 2 diabetes mellitus, Sitagliptin Accord is indicated to improve glycaemic control: as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.- a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.- a peroxisome proliferator-activated receptor gamma (PPARy) agonist (i.e. a thiazolidinedione) when use of a PPARy agonist is appropriate and when diet and exercise plus the PPARy agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.- a PPARy agonist and metformin when use of a PPARy agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Sitagliptin Accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AG-SITAGLIPTIN0253551325 MGTABLET · ORALANGITA PHARMA INC.
AG-SITAGLIPTIN0253552150 MGTABLET · ORALANGITA PHARMA INC.
AG-SITAGLIPTIN02535548100 MGTABLET · ORALANGITA PHARMA INC.
APO-SITAGLIPTIN0242826125 MGTABLET · ORALAPOTEX INC
APO-SITAGLIPTIN0242828850 MGTABLET · ORALAPOTEX INC
APO-SITAGLIPTIN02428296100 MGTABLET · ORALAPOTEX INC
APO-SITAGLIPTIN MALATE0250865625 MGTABLET · ORALAPOTEX INC
APO-SITAGLIPTIN MALATE0250866450 MGTABLET · ORALAPOTEX INC
APO-SITAGLIPTIN MALATE02508672100 MGTABLET · ORALAPOTEX INC
AURO-SITAGLIPTIN0252986625 MGTABLET · ORALAURO PHARMA INC
AURO-SITAGLIPTIN0252987450 MGTABLET · ORALAURO PHARMA INC
AURO-SITAGLIPTIN02529882100 MGTABLET · ORALAURO PHARMA INC
JAMP SITAGLIPTIN0253413425 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP SITAGLIPTIN0253414250 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP SITAGLIPTIN02534150100 MGTABLET · ORALJAMP PHARMA CORPORATION
JANUVIA02303922100 MGTABLET · ORALMERCK CANADA INC
JANUVIA0238883925 MGTABLET · ORALMERCK CANADA INC
JANUVIA0238884750 MGTABLET · ORALMERCK CANADA INC
M-SITAGLIPTIN0253498325 MGTABLET · ORALMANTRA PHARMA INC
M-SITAGLIPTIN0253499150 MGTABLET · ORALMANTRA PHARMA INC
M-SITAGLIPTIN02535009100 MGTABLET · ORALMANTRA PHARMA INC
MINT-SITAGLIPTIN0255391025 MGTABLET · ORALMINT PHARMACEUTICALS INC
MINT-SITAGLIPTIN0255392950 MGTABLET · ORALMINT PHARMACEUTICALS INC
MINT-SITAGLIPTIN02553937100 MGTABLET · ORALMINT PHARMACEUTICALS INC
NAT-SITAGLIPTIN02543400100 MGTABLET · ORALNATCO PHARMA (CANADA) INC

26 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACJANUVIA 100 MG TABLET$10.55179per EA23 Sep 2026
US NADACJANUVIA 25 MG TABLET$10.54364per EA23 Sep 2026
US NADACJANUVIA 50 MG TABLET$10.55215per EA23 Sep 2026
US NADACSITAGLIPTIN PHOSPHATE 100 MG TABLET$3.77084per EA5 Aug 2026
US NADACSITAGLIPTIN PHOSPHATE 25 MG TABLET$3.46931per EA5 Aug 2026
US NADACSITAGLIPTIN PHOSPHATE 50 MG TABLET$3.6838per EA5 Aug 2026
US NADACZITUVIO 100 MG TABLET$10.08225per EA23 Sep 2026
US NADACZITUVIO 25 MG TABLET$10.05424per EA23 Sep 2026
US NADACZITUVIO 50 MG TABLET$10.04956per EA23 Sep 2026
NHS Drug TariffSitagliptin 100mg tablets£2.0528 tablet1 Oct 2026
NHS Drug TariffSitagliptin 100mg/5ml oral solution sugar free£75.00150 ml1 Oct 2026
NHS Drug TariffSitagliptin 25mg tablets£1.4828 tablet1 Oct 2026
NHS Drug TariffSitagliptin 50mg tablets£1.7228 tablet1 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.

Safety signals and safety-related labeling changes

All safety entries for sitagliptin →

Combinations containing Sitagliptin

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.