Prescription medicine

Sitagliptin Brand names: Januvia, Zituvio, Brynovin

Sitagliptin (Januvia) is a prescription medicine with an FDA approval on record since 2006. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $3.77 per sitagliptin phosphate 100 mg tablet in the October 7, 2026 NADAC survey.

Generic listed

Check it at the source: the sitagliptin FDA label on DailyMed (effective November 14, 2024, Merck Sharp & Dohme LLC); the NDA 21995 record on Drugs@FDA; every sitagliptin label on DailyMed.

Highlights of the record

FDA label of November 14, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage
JANUVIA ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Forms and strengths

25 mg
50 mg
100 mg
25 mg/ml

Film-coated tablet; tablet; solution.

On the market

Earliest approval on file: October 16, 2006 Januvia, Msd; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 3 first December 29, 2025; 3 with a marketed status in Drugs@FDA
Labelers listed (NDC): 10 of which 4 under generic applications, 6 under brand applications, repackagers included
Last listed patent: May 24, 2027 Januvia tablets; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): $3.77 per tablet Sitagliptin phosphate 100 mg tablet
Shortage (FDA): No current entry
Recalls by its makers (FDA): 1 since 2013 0 Class I among all firms' recalls; latest July 2, 2013
FAERS reports: 74,197 through July 30, 2026

What is sitagliptin used for?

From the label: indications and usage
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. […]

Conditions named in the indications of sitagliptin's FDA labels, with every medicine labeled for each:

Type 2 diabetes

FDA pharmacologic class: Dipeptidyl Peptidase 4 Inhibitor.

Source: FDA drug label (JANUVIA), NDA021995 (Msd), as published by Merck Sharp & Dohme LLC, effective November 14, 2024 (SPL set f85a48d0-0407-4c50-b0fa-7673a160bf01), via openFDA; the full label on DailyMed

What does the patient leaflet for sitagliptin say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about JANUVIA?
JANUVIA can cause serious side effects, including: Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis. Before you start taking JANUVIA, tell your doctor if you have ever had: pancreatitis high blood triglyceride levels stones in your gallbladder (gallstones) kidney problems a history of alcoholism Stop taking JANUVIA and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis. Heart failure. Heart failure means your heart does not pump blood well enough. Before you start taking JANUVIA, tell your doctor if you have ever had heart failure or have problems with your kidneys. Contact your doctor right away if you have any of the following symptoms: increasing shortness of breath or trouble breathing, especially when you lie down swelling or fluid retention, especially in the feet, ankles or legs an unusually fast increase in weight unusual tiredness These may be symptoms of heart failure.

From the patient leaflet: How should I store JANUVIA?
Store JANUVIA at room temperature, between 68°F to 77°F (20°C to 25°C). Keep JANUVIA and all medicines out of the reach of children.

Is there a generic for sitagliptin (Januvia)?

The FDA approved the first generic sitagliptin on December 29, 2025. 3 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 16 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.

FDA's NDC Directory lists sitagliptin from 4 labelers under a generic (ANDA) application and from 6 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists 1 patent for Januvia tablets: the compound patent runs to November 24, 2026 (pediatric exclusivity to May 24, 2027); a patent listed only for Brynovin oral solution runs to October 23, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2006 earliest approval on file
2025 first generic approved
2027 last listed patent
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for sitagliptin (Januvia)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $3.77 per Sitagliptin phosphate 100 mg tablet. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Sitagliptin phosphate 100 mg tablet (generic)
Januvia 100 mg tablet (brand)

$18.34

$3.77

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Sitagliptin phosphate 100 mg tablet	Generic	$3.77 per tablet	$113.13	n/a
Sitagliptin phosphate 25 mg tablet	Generic	$3.47 per tablet	$104.08	n/a
Sitagliptin phosphate 50 mg tablet	Generic	$3.68 per tablet	$110.51	n/a
Januvia 100 mg tablet	Brand	$10.55 per tablet	$316.55	no change
Januvia 25 mg tablet	Brand	$10.54 per tablet	$316.31	no change
Januvia 50 mg tablet	Brand	$10.55 per tablet	$316.56	no change
Zituvio 100 mg tablet	Brand	$10.08 per tablet	$302.47	+0.1%
Zituvio 25 mg tablet	Brand	$10.05 per tablet	$301.63	no change
Zituvio 50 mg tablet	Brand	$10.05 per tablet	$301.49	no change

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has sitagliptin been recalled?

The FDA's Enforcement Report lists 1 recall naming sitagliptin since 2013: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
July 2, 2013	Class II	Aidapak Services, LLC	Labeling: Label Mixup: sitaGLIPtin PHOSPHATE, Tablet, 50 mg may be potentially mis-labeled as one of the following drugs: LACTOBACILLUS, Tablet, 0 mg, NDC …

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the sitagliptin label say about other medicines?

The sitagliptin label names no other medicine on this site. The labels of 4 other medicines name sitagliptin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Check sitagliptin against other medicines

What do FAERS reports show for sitagliptin?

The FDA Adverse Event Reporting System holds 74,197 reports that list sitagliptin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,991 are coded as a death and 26,159 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Blood Glucose Increased4,597
Nausea (named in the label)4,005
Diarrhoea (named in the label)3,700
Drug Ineffective (a use or a product term, not a reaction)3,605
Fatigue3,030
Headache (named in the label)2,604
Dizziness (named in the label)2,536
Vomiting (named in the label)2,488

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as sitagliptin?

31 other medicines are given the same way (oral) and in the same FDA class as sitagliptin or labeled mainly for the same use (type 2 diabetes), the same class first. Type 2 diabetes lists all 52 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (oral)	Pharmacy cost	Shortage
Alogliptin	Type 2 diabetes	none listed	$4.96 per tablet 12.5 mg tablet	No current entry
Alogliptin and pioglitazone	Type 2 diabetes	none listed	$4.73 per tablet 25-15 mg tablet	No current entry
Linagliptin and metformin	Type 2 diabetes	1 labeler	$8.44 per tablet 2.5 mg-1,000 mg tablet	No current entry
Metformin and saxagliptin	Type 2 diabetes	2 labelers	$9.65 per tablet 5-1,000 mg tablet	No current entry
Saxagliptin	Type 2 diabetes	3 labelers	$1.04 per tablet 5 mg tablet	No current entry
Alogliptin and metformin	Type 2 diabetes	none listed	$2.46 per unit 12.5-1000	No current entry
Empagliflozin and linagliptin and metformin	Type 2 diabetes	none listed	$11.28 per tablet 10-5-1,000 mg tablet	No current entry
Linagliptin	Type 2 diabetes	none listed	$16.80 per tablet 5 mg tablet	No current entry

Every medicine labeled for the same conditions as sitagliptin

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does sitagliptin compare with medicines for the same use?

10 side-by-side pages set sitagliptin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Alternatives to sitagliptin: 31 medicines for the same use
Other DPP-4 inhibitors: the pharmacologic class, with prices and generics
Sitagliptin side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other