Prescription medicine

Dapagliflozin and saxagliptin First approved as Qtern

Dapagliflozin and saxagliptin (Qtern) is a prescription medicine with an FDA approval on record since 2017. FDA's NDC Directory lists it from 1 generic labeler.

Generic listed

Check it at the source: the dapagliflozin and saxagliptin FDA label on DailyMed (effective April 8, 2026, Novadoz Pharmaceuticals LLC); the NDA 209091 record on Drugs@FDA; every dapagliflozin and saxagliptin label on DailyMed.

Highlights of the record

FDA label of April 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
Dapagliflozin and saxagliptin tablets are 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

Film-coated tablet.

On the market

Earliest approval on file: February 27, 2017 Qtern, Astrazeneca Ab; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 2 first April 6, 2026; 2 with a marketed status in Drugs@FDA
Labelers listed (NDC): 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Last listed patent: June 16, 2030 Qtern 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

What is dapagliflozin and saxagliptin used for?

From the label: indications and usage
Dapagliflozin and saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin and saxagliptin tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [ see WARNINGS AND PRECAUTIONS (5.1) ]. Dapagliflozin and saxagliptin tablets is a combination of dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor and saxagliptin 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 dapagliflozin and saxagliptin's FDA labels, with every medicine labeled for each:

Type 2 diabetes

FDA pharmacologic class: Sodium-Glucose Cotransporter 2 Inhibitor.

Source: FDA drug label (DAPAGLIFLOZIN AND SAXAGLIPTIN), ANDA211533 (Msn), as published by Novadoz Pharmaceuticals LLC, effective April 8, 2026 (SPL set 1cfa51fd-8406-404c-b2a8-0fc1068675fb), via openFDA; the full label on DailyMed

Is there a generic for dapagliflozin and saxagliptin (Qtern)?

The FDA approved the first generic dapagliflozin and saxagliptin on April 6, 2026. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists dapagliflozin and saxagliptin from 1 labeler 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 6 patents for Qtern tablets: the compound patent runs to December 16, 2029 (pediatric exclusivity to June 16, 2030). 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
2026 first generic approved
2030 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the dapagliflozin and saxagliptin label say about other medicines?

The dapagliflozin and saxagliptin label names 8 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
Atazanavir	drug interactions	Clinical Impact; Ketoconazole significantly increased saxagliptin exposure. 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 …
Clarithromycin	drug interactions	Clinical Impact; Ketoconazole significantly increased saxagliptin exposure. 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 …
Itraconazole	drug interactions	Clinical Impact; Ketoconazole significantly increased saxagliptin exposure. 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 …
Ketoconazole	drug interactions	Clinical Impact; Ketoconazole significantly increased saxagliptin exposure. 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 …
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 dapagliflozin and saxagliptin initiation and dosage changes.
Nefazodone	drug interactions	Clinical Impact; Ketoconazole significantly increased saxagliptin exposure. 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 …
Nelfinavir	drug interactions	… with other strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin).
Ritonavir	drug interactions	… strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin).

Check dapagliflozin and saxagliptin against other medicines

What else is labeled for the same conditions as dapagliflozin and saxagliptin?

32 other medicines are given the same way (oral) and in the same FDA class as dapagliflozin and 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
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
Bexagliflozin	Type 2 diabetes	none listed	n/a	No current entry
Empagliflozin and linagliptin	Type 2 diabetes	none listed	$11.24 per tablet 10 mg-5 mg tablet	No current entry
Metformin	Type 2 diabetes	83 labelers	$0.0145 per tablet 500 mg tablet	No current entry

Every medicine labeled for the same conditions as dapagliflozin and saxagliptin

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to dapagliflozin and saxagliptin: 32 medicines for the same use
Other SGLT2 inhibitors: the pharmacologic class, with prices and generics
Check an interaction: what two or more labels say about each other