Prescription medicine
Bexagliflozin Brand names: Brenzavvy
Bexagliflozin (Brenzavvy) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the bexagliflozin FDA label on DailyMed (effective June 23, 2026, TheracosBio, LLC); the NDA 214373 record on Drugs@FDA; every bexagliflozin label on DailyMed.
Highlights of the record
FDA label of June 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageBexagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Forms and strengths
- 20 mg
Tablet.
On the market
- Earliest approval on file
- January 20, 2023 Brenzavvy, Theracosbio; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 5, 2041 Brenzavvy tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 26 through July 30, 2026
What is bexagliflozin used for?
From the label: indications and usageBexagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Bexagliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. [see Warnings and Precautions ( 5.1 )]. Bexagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitation of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.
Conditions named in the indications of bexagliflozin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Sodium-Glucose Cotransporter 2 Inhibitor.
Source: FDA drug label (Bexagliflozin), TheracosBio, LLC, effective June 23, 2026 (SPL set 7f0ad5d2-3509-4057-904c-d27993de7408), via openFDA; the full label on DailyMed
What does the patient leaflet for bexagliflozin 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 bexagliflozin tablets?Bexagliflozin tablets can cause serious side effects, including: Diabetic Ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis. Bexagliflozin tablets 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: o pain or tenderness o swelling o 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. Vaginal yeast infection. […]
From the patient leaflet: How should I store bexagliflozin tablets?Store bexagliflozin tabletsat room temperature between 68 °F to 77 °F (20 °C to 25 °C). Keep bexagliflozin tabletsand all medicines out of the reach of children.
Source: FDA drug label (Bexagliflozin), TheracosBio, LLC, effective June 23, 2026 (SPL set 7f0ad5d2-3509-4057-904c-d27993de7408), via openFDA; the full label on DailyMed
Is there a generic for bexagliflozin (Brenzavvy)?
No generic bexagliflozin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 7 patents for Brenzavvy tablets: the compound patent runs to May 14, 2032, and the last listed entry to October 5, 2041. 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
- 2041 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the bexagliflozin label say about other medicines?
The bexagliflozin label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name bexagliflozin. 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 with SGLT2 inhibitors such as bexagliflozin tablets may decrease serum lithium concentrations. Intervention Monitor serum lithium concentration more frequently upon bexagliflozin tablets initiation and discontinuation. |
Source: FDA drug label (Bexagliflozin), TheracosBio, LLC, effective June 23, 2026 (SPL set 7f0ad5d2-3509-4057-904c-d27993de7408), via openFDA; the full label on DailyMed
What do FAERS reports show for bexagliflozin?
The FDA Adverse Event Reporting System holds 26 reports that list bexagliflozin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 2 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 bexagliflozin?
36 other medicines are given the same way (oral) and in the same FDA class as bexagliflozin 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 |
| Empagliflozin | Type 2 diabetes | none listed | $11.19 per tablet 10 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 |
| Empagliflozin and metformin | Type 2 diabetes | none listed | $5.60 per tablet 12.5-1,000 mg tablet | No current entry |
| Canagliflozin | Type 2 diabetes | none listed | $19.13 per tablet 100 mg tablet | 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 |
| Empagliflozin and linagliptin | Type 2 diabetes | none listed | $11.24 per tablet 10 mg-5 mg tablet | No current entry |
Every medicine labeled for the same conditions as bexagliflozin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to bexagliflozin
- 36 medicines for the same use
- Other SGLT2 inhibitors
- the pharmacologic class, with prices and generics
- Bexagliflozin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other