Prescription medicine
Empagliflozin and linagliptin Brand names: Glyxambi
Empagliflozin and linagliptin (Glyxambi) is a prescription medicine with an FDA approval on record since 2015. No generic is listed; pharmacies paid $11.24 per Glyxambi 10 mg-5 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the empagliflozin and linagliptin FDA label on DailyMed (effective January 20, 2026, Boehringer Ingelheim Pharmaceuticals, Inc.); the NDA 206073 record on Drugs@FDA; every empagliflozin and linagliptin label on DailyMed.
Highlights of the record
FDA label of January 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageGLYXAMBI is a combination of empagliflozin and linagliptin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Forms and strengths
- 10 mg / 5 mg
- 25 mg / 5 mg
Film-coated tablet.
On the market
- Earliest approval on file
- January 30, 2015 Glyxambi, Boehringer Ingelheim; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 8, 2037 Glyxambi tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $11.24 per tablet Glyxambi 10 mg-5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2021 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 1,937 through July 30, 2026
What is empagliflozin and linagliptin used for?
From the label: indications and usageGLYXAMBI is a combination of empagliflozin and linagliptin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin is indicated to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes mellitus and established CV disease [see Clinical Studies (14.2) ]. GLYXAMBI is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and linagliptin, 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. […]
Conditions named in the indications of empagliflozin and linagliptin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Dipeptidyl Peptidase 4 Inhibitor and Sodium-Glucose Cotransporter 2 Inhibitor.
Source: FDA drug label (Glyxambi), Boehringer Ingelheim Pharmaceuticals, Inc., effective January 20, 2026 (SPL set ddbab689-f76c-488c-9613-4168d41dd730), via openFDA; the full label on DailyMed
What does the patient leaflet for empagliflozin and linagliptin 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 GLYXAMBI?GLYXAMBI can cause serious side effects, including: Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 and other ketoacidosis. GLYXAMBI 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. Your healthcare provider may ask you to periodically check ketones in your urine or blood. Stop taking GLYXAMBI and call your healthcare provider or get medical help right away if you get any of the following. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL: nausea vomiting stomach-area (abdominal) pain tiredness trouble breathing ketones in your urine or blood Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis. […]
From the patient leaflet: How should I store GLYXAMBI?Store GLYXAMBI at room temperature between 68°F to 77°F (20°C to 25°C). Keep GLYXAMBI and all medicines out of the reach of children.
Source: FDA drug label (Glyxambi), Boehringer Ingelheim Pharmaceuticals, Inc., effective January 20, 2026 (SPL set ddbab689-f76c-488c-9613-4168d41dd730), via openFDA; the full label on DailyMed
Is there a generic for empagliflozin and linagliptin (Glyxambi)?
No generic empagliflozin and linagliptin is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 5 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 15 patents for Glyxambi tablets: the compound patent runs to August 1, 2028 (pediatric exclusivity to February 1, 2029), and the last listed entry to December 8, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2037 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 empagliflozin and linagliptin (Glyxambi)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $11.24 per Glyxambi 10 mg-5 mg tablet, down 44% from $20.18 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. 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.
- Glyxambi 25 mg-5 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Glyxambi 10 mg-5 mg tablet | Brand | $11.24 per tablet | $337.31 | -44% |
| Glyxambi 25 mg-5 mg tablet | Brand | $11.20 per tablet | $335.98 | -44% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has empagliflozin and linagliptin been recalled?
The FDA's Enforcement Report lists 1 recall naming empagliflozin and linagliptin since 2021: 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 |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the empagliflozin and linagliptin label say about other medicines?
The empagliflozin and linagliptin label names 2 other medicines 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 | Lithium Clinical Impact Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention Monitor serum lithium concentration more frequently during GLYXAMBI initiation and dosage changes. |
| Rifampin | drug interactions | Clinical Impact; Rifampin decreased linagliptin exposure, suggesting that the efficacy of linagliptin may be reduced when administered in combination with a strong P-gp or CYP3A4 inducer. |
Source: FDA drug label (Glyxambi), Boehringer Ingelheim Pharmaceuticals, Inc., effective January 20, 2026 (SPL set ddbab689-f76c-488c-9613-4168d41dd730), via openFDA; the full label on DailyMed
What do FAERS reports show for empagliflozin and linagliptin?
The FDA Adverse Event Reporting System holds 1,937 reports that list empagliflozin and linagliptin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 63 are coded as a death and 466 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 empagliflozin and linagliptin?
31 other medicines are given the same way (oral) and in the same FDA class as empagliflozin and linagliptin 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 |
|---|---|---|---|---|
| Dapagliflozin | Type 2 diabetes | 22 labelers | $0.184 per tablet 10 mg tablet | No current entry |
| Dapagliflozin and metformin | Type 2 diabetes | 8 labelers | $0.720 per tablet 10-1,000 mg tablet | No current entry |
| Metformin and sitagliptin | Type 2 diabetes | 4 labelers | $1.76 per tablet 50 mg-1,000 mg tablet | No current entry |
| Sitagliptin | Type 2 diabetes | 4 labelers | $3.77 per tablet 100 mg tablet | No current entry |
| 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 |
| Canagliflozin and metformin | Type 2 diabetes | none listed | $9.58 per tablet 150-1,000 mg tablet | No current entry |
| Canagliflozin | Type 2 diabetes | none listed | $19.13 per tablet 100 mg tablet | No current entry |
Every medicine labeled for the same conditions as empagliflozin and linagliptin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to empagliflozin and linagliptin
- 31 medicines for the same use
- Other DPP-4 inhibitors
- the pharmacologic class, with prices and generics
- Empagliflozin and linagliptin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other