Januvia
An oral daily medication used to improve blood sugar control in adults with type 2 diabetes.
Where Sitagliptin is approved
All regulators →Of the three regulators tracked here, the first to approve Sitagliptin was the US, on 16 Oct 2006. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Sitagliptin patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Sitagliptin, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 4 listed patents; the last listed expires 23 Oct 2040 (US 12295953).
- Latest patent on the drug substance itself: 24 May 2027 (US 7326708, with paediatric extension).
Reproduced from the FDA Orange Book and Purple Book (checked 5 Oct 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Sitagliptin
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Sitagliptin works
All drug targets →- Dipeptidyl peptidase IV inhibitor InhibitorTarget: DPP4 dipeptidyl peptidase 4✓ In ChEMBL and the Guide to Pharmacology
- COVID-19Phase 3
- Cognitive impairmentPhase 3
- HIV infectious diseasePhase 3
- HyperglycemiaPhase 3
- HypoglycemiaPhase 3
- Insulin resistancePhase 3
- Acute myocardial infarctionPhase 3
- Cardiovascular disorderPhase 3
- Chronic kidney diseasePhase 3
- Diabetic footPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1422, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 6286, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Sitagliptin
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 28 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Januvia, Ristaben, Tesavel, Xelevia, Sitagliptin Accord (generic), Sitagliptin SUN (generic)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Sitagliptin
- ATC code
- A10BH01
- ChEMBL
- CHEMBL1422
- DrugBank
- DB01261
- PubChem CID
- 4369359
- CAS number
- 486460-32-6
- FDA UNII
- QFP0P1DV7Z
- Wikidata
- Q419832
- Wikipedia
- Sitagliptin
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Januvia is used for
JANUVIA ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUVIA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: JANUVIA should not be used in patients with type 1 diabetes ( 1 ) JANUVIA has not been studied in patients with a history of pancreatitis. ( 1 , 5.1 ) Limitations of Use JANUVIA should not be used in patients with type 1 diabetes. JANUVIA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUVIA. [See Warnings and Precautions (5.1) .]
How it works
12.1 Mechanism of Action Sitagliptin is a DPP-4 inhibitor, which is believed to exert its actions in patients with type 2 diabetes mellitus by slowing the inactivation of incretin hormones. Concentrations of the active intact hormones are increased by sitagliptin, thereby increasing and prolonging the action of these hormones. Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal. These hormones are rapidly inactivated by the enzyme, DPP-4. The incretins are part of an endogenous system involved in the physiologic regulation of gluco…
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 6 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.