Prescription medicine
Ertugliflozin and sitagliptin Brand names: Steglujan
Ertugliflozin and sitagliptin (Steglujan) is a prescription medicine with an FDA approval on record since 2017. No generic is listed; pharmacies paid $17.59 per Steglujan 15-100 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the ertugliflozin and sitagliptin FDA label on DailyMed (effective June 3, 2026, Merck Sharp & Dohme LLC); the NDA 209805 record on Drugs@FDA; every ertugliflozin and sitagliptin label on DailyMed.
Highlights of the record
FDA label of June 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSTEGLUJAN ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Forms and strengths
- 5 mg / 100 mg
- 15 mg / 100 mg
Film-coated tablet.
On the market
- Earliest approval on file
- December 19, 2017 Steglujan, Msd Sub Merck; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 19, 2031 Steglujan tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $17.59 per tablet Steglujan 15-100 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 118 through July 30, 2026
What is ertugliflozin and sitagliptin used for?
From the label: indications and usageSTEGLUJAN ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1) ]. 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 STEGLUJAN [see Warnings and Precautions (5.2) ]. […]
Conditions named in the indications of ertugliflozin and sitagliptin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Dipeptidyl Peptidase 4 Inhibitor.
Source: FDA drug label (STEGLUJAN), Merck Sharp & Dohme LLC, effective June 3, 2026 (SPL set c2c553d8-5a9d-4366-bf53-8bdb5a876d19), via openFDA; the full label on DailyMed
What does the patient leaflet for ertugliflozin and 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 STEGLUJAN?STEGLUJAN may cause serious side effects, including: Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis. STEGLUJAN can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who are sick, cannot eat or drink as usual, skip meals, are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. […] Seek medical attention immediately if you have a fever or you are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness swelling redness of skin (erythema) Also tell your healthcare provider if you have any of these signs or symptoms of urinary tract infections or yeast infections: Urinary tract infection: burning feeling when you urinate need to urinate often or right away pain in the lower part of your stomach (pelvis) blood in your urine You may also have a fever, back pain, nausea, or vomiting. […]
From the patient leaflet: How should I store STEGLUJAN?Store STEGLUJAN at room temperature between 68°F to 77°F (20°C to 25°C). Keep STEGLUJAN dry. Keep STEGLUJAN and all medicines out of the reach of children.
Source: FDA drug label (STEGLUJAN), Merck Sharp & Dohme LLC, effective June 3, 2026 (SPL set c2c553d8-5a9d-4366-bf53-8bdb5a876d19), via openFDA; the full label on DailyMed
Is there a generic for ertugliflozin and sitagliptin (Steglujan)?
No generic ertugliflozin and sitagliptin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Steglujan tablets: the compound patent runs to December 19, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ertugliflozin and sitagliptin (Steglujan)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $17.59 per Steglujan 15-100 mg tablet, about the same as a year earlier. 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.
- Steglujan 15-100 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Steglujan 15-100 mg tablet | Brand | $17.59 per tablet | $527.59 | -0.7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the ertugliflozin and sitagliptin label say about other medicines?
The ertugliflozin and sitagliptin label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Lithium | drug interactions | Clinical Impact: Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention: Monitor serum lithium concentration more frequently during STEGLUJAN initiation and dosage changes. |
Source: FDA drug label (STEGLUJAN), Merck Sharp & Dohme LLC, effective June 3, 2026 (SPL set c2c553d8-5a9d-4366-bf53-8bdb5a876d19), via openFDA; the full label on DailyMed
What do FAERS reports show for ertugliflozin and sitagliptin?
The FDA Adverse Event Reporting System holds 118 reports that list ertugliflozin and sitagliptin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 44 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ertugliflozin and sitagliptin?
29 other medicines are given the same way (oral) and in the same FDA class as ertugliflozin and 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 ertugliflozin and sitagliptin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ertugliflozin and sitagliptin
- 29 medicines for the same use
- Other DPP-4 inhibitors
- the pharmacologic class, with prices and generics
- Ertugliflozin and sitagliptin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other