Prescription medicine
Sotagliflozin Brand names: Inpefa
Sotagliflozin (Inpefa) is a prescription medicine with an FDA approval on record since 2023. No generic is listed; pharmacies paid $20.37 per Inpefa 200 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the sotagliflozin FDA label on DailyMed (effective August 12, 2026, Lexicon Pharmaceuticals, Inc.); the NDA 216203 record on Drugs@FDA; every sotagliflozin label on DailyMed.
Highlights of the record
FDA label of August 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageINPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors INPEFA is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart fa
Forms and strengths
- 200 mg
- 400 mg
Tablet.
On the market
- Earliest approval on file
- May 26, 2023 Inpefa, Lexicon Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- October 7, 2030 Inpefa tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $20.37 per tablet Inpefa 200 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 541 through July 30, 2026
What is sotagliflozin used for?
From the label: indications and usageINPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors INPEFA is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: heart failure ( 1 ) or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors
Conditions named in the indications of sotagliflozin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Sodium-Glucose Cotransporter 2 Inhibitor.
Source: FDA drug label (INPEFA), Lexicon Pharmaceuticals, Inc., effective August 12, 2026 (SPL set 1a46614e-05f6-421a-b6f4-d6f8760d643a), via openFDA; the full label on DailyMed
What does the patient leaflet for sotagliflozin 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 INPEFA?INPEFA can cause serious side effects, including: Ketoacidosis (acidic blood with increased ketones in your blood or urine ). Ketoacidosis has happened in people who have type 1 or type 2 diabetes during treatment with INPEFA. Ketoacidosis can happen with INPEFA even if your blood sugar is not high. Your healthcare provider may ask you to periodically check ketones in your urine or blood. Ketoacidosis can also happen in people who are sick or who have surgery during treatment with INPEFA. Ketoacidosis is a serious condition which needs to be treated in a hospital. Ketoacidosis may lead to death. Stop taking INPEFA and call your healthcare provider or get medical help right away if you get any of the following symptoms. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL: nausea vomiting trouble breathing stomach-area (abdominal) pain tiredness ketones in your urine or blood Dehydration. […] 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 INPEFA?Store INPEFA at room temperature between 68°F to 77°F (20°C to 25°C). Keep INPEFA and all medicines out of the reach of children.
Source: FDA drug label (INPEFA), Lexicon Pharmaceuticals, Inc., effective August 12, 2026 (SPL set 1a46614e-05f6-421a-b6f4-d6f8760d643a), via openFDA; the full label on DailyMed
Is there a generic for sotagliflozin (Inpefa)?
No generic sotagliflozin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Inpefa tablets: the compound patent runs to October 7, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2030 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for sotagliflozin (Inpefa)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $20.37 per Inpefa 200 mg tablet, up 3% from $19.73 on October 8, 2025. 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.
- Inpefa 200 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Inpefa 200 mg tablet | Brand | $20.37 per tablet | $611.08 | +3% |
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 sotagliflozin label say about other medicines?
The sotagliflozin label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name sotagliflozin. 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 |
|---|---|---|
| Digoxin | drug interactions | DRUG INTERACTIONS Digoxin: Monitor digoxin levels. ( 7.1 ) Uridine 5'-diphospho-glucuronosyltransferase Inducers (e.g., rifampin): |
| Lithium | drug interactions | Consider monitoring of clinical status. ( 7.2 ) Lithium: Monitor serum lithium concentrations. |
| Rifampin | drug interactions | DRUG INTERACTIONS Digoxin: Monitor digoxin levels. ( 7.1 ) Uridine 5'-diphospho-glucuronosyltransferase Inducers (e.g., rifampin): |
Source: FDA drug label (INPEFA), Lexicon Pharmaceuticals, Inc., effective August 12, 2026 (SPL set 1a46614e-05f6-421a-b6f4-d6f8760d643a), via openFDA; the full label on DailyMed
What do FAERS reports show for sotagliflozin?
The FDA Adverse Event Reporting System holds 541 reports that list sotagliflozin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 43 are coded as a death and 103 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as sotagliflozin?
18 other medicines are given the same way (oral) and in the same FDA class as sotagliflozin or labeled mainly for the same use (heart failure), the same class first. Heart failure lists all 37 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 |
|---|---|---|---|---|
| Dapagliflozin | Heart failure | 22 labelers | $0.184 per tablet 10 mg tablet | No current entry |
| Dapagliflozin and metformin | Heart failure | 8 labelers | $0.720 per tablet 10-1,000 mg tablet | No current entry |
| Empagliflozin | Heart failure | none listed | $11.19 per tablet 10 mg tablet | No current entry |
| Carvedilol | Heart failure | 41 labelers | $0.0179 per tablet 6.25 mg tablet | No current entry |
| Spironolactone | Heart failure | 38 labelers | $0.0426 per tablet 25 mg tablet | A presentation being discontinued |
| Hydrochlorothiazide | Heart failure | 44 labelers | $0.0115 per tablet 25 mg tablet | A presentation being discontinued |
| Furosemide | Heart failure | 33 labelers | $0.026 per tablet 20 mg tablet | In shortage |
| Sacubitril and valsartan | Heart failure | 27 labelers | $0.533 per unit 49-51 mg | No current entry |
Every medicine labeled for the same conditions as sotagliflozin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to sotagliflozin
- 18 medicines for the same use
- Other SGLT2 inhibitors
- the pharmacologic class, with prices and generics
- Sotagliflozin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other