Prescription medicine
Saxagliptin First approved as Onglyza
Saxagliptin (Onglyza) is a prescription medicine with an FDA approval on record since 2009. FDA's NDC Directory lists it from 3 generic labelers, and pharmacies paid $1.04 per saxagliptin HCl 5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the saxagliptin FDA label on DailyMed (effective January 27, 2026, Glenmark Pharmaceuticals Inc., USA); the NDA 22350 record on Drugs@FDA; every saxagliptin label on DailyMed.
Highlights of the record
FDA label of January 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSaxagliptin tablets are 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.
Forms and strengths
- 2.5 mg
- 5 mg
Film-coated tablet.
On the market
- Earliest approval on file
- July 31, 2009 Onglyza, Astrazeneca Ab; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first July 31, 2023; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 3 under generic applications, 0 under brand applications, repackagers included
- Last listed patent
- November 30, 2028 Onglyza tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $1.04 per tablet Saxagliptin HCl 5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2025 0 Class I among all firms' recalls; latest March 13, 2025
- FAERS reports
- 1,458 through July 30, 2026
What is saxagliptin used for?
From the label: indications and usageSaxagliptin tablets are 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. ( 1.1 ) Limitations of use:
Not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. […]
Conditions named in the indications of saxagliptin's FDA labels, with every medicine labeled for each:
From other saxagliptin labelsType 2 diabetes: Saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [ see Clinical Studies ( 14 ) ].
FDA pharmacologic class: Dipeptidyl Peptidase 4 Inhibitor.
Source: FDA drug label (SAXAGLIPTIN), Glenmark Pharmaceuticals Inc., USA, effective January 27, 2026 (SPL set e286ffd4-c598-47fb-af06-2e15f7e6f99f), via openFDA; the full label on DailyMed
What does the patient leaflet for saxagliptin 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 saxagliptin tablets?Serious side effects can happen to people taking saxagliptin tablets, including: 1)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 saxagliptin tablets: Tell your healthcare provider if you have ever had • inflammation of your pancreas (pancreatitis) • stones in your gallbladder (gallstones) • a history of alcoholism • high blood triglyceride levels Stop taking saxagliptin tablets and contact your healthcare provider 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. 2)Heart failure. Heart failure means your heart does not pump blood well enough. Before you start taking saxagliptin tablets: Tell your healthcare provider if you • have ever had heart failure or have problems with your kidneys. Contact your healthcare provider right away if you have any of the following symptoms: • increasing shortness of breath or trouble breathing, especially when you lie down • an unusually fast increase in weight • swelling or fluid retention, especially in the feet, ankles or legs • unusual tiredness These may be symptoms of heart failure.
From the patient leaflet: How should I store saxagliptin tablets?Store saxagliptin tablets between 68°F to 77°F (20°C to 25°C). Keep saxagliptin tablets and all medicines out of the reach of children
Source: FDA drug label (SAXAGLIPTIN), Glenmark Pharmaceuticals Inc., USA, effective January 27, 2026 (SPL set e286ffd4-c598-47fb-af06-2e15f7e6f99f), via openFDA; the full label on DailyMed
Is there a generic for saxagliptin (Onglyza)?
The FDA approved the first generic saxagliptin on July 31, 2023. 5 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 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists saxagliptin from 3 labelers under a generic (ANDA) application. 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 Onglyza tablets, the last expiring on November 30, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2009 earliest approval on file
- 2023 first generic approved
- 2028 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 saxagliptin (Onglyza)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.04 per Saxagliptin HCl 5 mg tablet, down 74% from $3.94 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.
- Saxagliptin HCl 5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Saxagliptin HCl 2.5 mg tablet | Generic | $1.14 per tablet | $34.33 | -68% |
| Saxagliptin HCl 5 mg tablet | Generic | $1.04 per tablet | $31.16 | -74% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has saxagliptin been recalled?
The FDA's Enforcement Report lists 2 recalls naming saxagliptin since 2025: 0 Class I (the most serious), 2 Class II, 0 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 13, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the saxagliptin label say about other medicines?
The saxagliptin label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name saxagliptin. 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 |
|---|---|---|
| Atazanavir | drug interactions | Similar significant increases in plasma concentrations of saxagliptin are anticipated with other strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). |
| Clarithromycin | drug interactions | Similar significant increases in plasma concentrations of saxagliptin are anticipated with other strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). |
| Itraconazole | drug interactions | Similar significant increases in plasma concentrations of saxagliptin are anticipated with other strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). |
| Ketoconazole | drug interactions | Strong CYP3A4/5 inhibitors (e.g., ketoconazole): Coadministration with saxagliptin significantly increases saxagliptin concentrations. |
| Nefazodone | drug interactions | Similar significant increases in plasma concentrations of saxagliptin are anticipated with other strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). |
| Nelfinavir | drug interactions | Similar significant increases in plasma concentrations of saxagliptin are anticipated with other strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). |
| Ritonavir | drug interactions | Similar significant increases in plasma concentrations of saxagliptin are anticipated with other strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). |
Source: FDA drug label (SAXAGLIPTIN), Glenmark Pharmaceuticals Inc., USA, effective January 27, 2026 (SPL set e286ffd4-c598-47fb-af06-2e15f7e6f99f), via openFDA; the full label on DailyMed
What do FAERS reports show for saxagliptin?
The FDA Adverse Event Reporting System holds 1,458 reports that list saxagliptin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 96 are coded as a death and 854 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 saxagliptin?
31 other medicines are given the same way (oral) and in the same FDA class as saxagliptin 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 |
|---|---|---|---|---|
| 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 |
| Linagliptin and metformin | Type 2 diabetes | 1 labeler | $8.44 per tablet 2.5 mg-1,000 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 saxagliptin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does saxagliptin compare with medicines for the same use?
1 side-by-side page set saxagliptin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to saxagliptin
- 31 medicines for the same use
- Other DPP-4 inhibitors
- the pharmacologic class, with prices and generics
- Saxagliptin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other