Prescription medicine
Linagliptin Brand names: Tradjenta
Linagliptin (Tradjenta) is a prescription medicine with an FDA approval on record since 2011. No generic is listed; pharmacies paid $16.80 per Tradjenta 5 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the linagliptin FDA label on DailyMed (effective March 21, 2025, Boehringer Ingelheim Pharmaceuticals, Inc.); the NDA 201280 record on Drugs@FDA; every linagliptin label on DailyMed.
Highlights of the record
FDA label of March 21, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Forms and strengths
- 5 mg
Film-coated tablet.
On the market
- Earliest approval on file
- May 2, 2011 Tradjenta, Boehringer Ingelheim; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first August 31, 2021; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 0 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- December 8, 2037 Tradjenta tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $16.80 per tablet Tradjenta 5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 18,132 through July 30, 2026
What is linagliptin used for?
From the label: indications and usageTRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. TRADJENTA is 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 ) Limitations of Use Not recommended in patients with type 1 diabetes mellitus as it would not be effective ( 1 ) Has not been studied in patients with a history of pancreatitis ( 1 ) Limitations of Use TRADJENTA is not recommended in patients with type 1 diabetes mellitus as it would not be effective. TRADJENTA has not been studied in patients with a history of pancreatitis. […]
Conditions named in the indications of linagliptin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Dipeptidyl Peptidase 4 Inhibitor.
Source: FDA drug label (Tradjenta), Boehringer Ingelheim Pharmaceuticals, Inc., effective March 21, 2025 (SPL set c797ea5c-cab7-494b-9044-27eba0cfe40f), via openFDA; the full label on DailyMed
What does the patient leaflet for 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 TRADJENTA?TRADJENTA can cause serious side effects, including: 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 TRADJENTA, tell your healthcare provider if you have ever had: inflammation of your pancreas (pancreatitis) a history of alcoholism stones in your gallbladder (gallstones) high blood triglyceride levels Stop taking TRADJENTA and call 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 to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
From the patient leaflet: How should I store TRADJENTA?Store TRADJENTA at room temperature between 68°F and 77°F (20°C and 25°C). Keep TRADJENTA and all medicines out of the reach of children.
Source: FDA drug label (Tradjenta), Boehringer Ingelheim Pharmaceuticals, Inc., effective March 21, 2025 (SPL set c797ea5c-cab7-494b-9044-27eba0cfe40f), via openFDA; the full label on DailyMed
Is there a generic for linagliptin (Tradjenta)?
The FDA approved the first generic linagliptin on August 31, 2021. 8 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 10 patents for Tradjenta tablets, the last expiring on 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.
- 2011 earliest approval on file
- 2021 first generic approved
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for linagliptin (Tradjenta)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $16.80 per Tradjenta 5 mg tablet, about the same as a year earlier. 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.
- Tradjenta 5 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tradjenta 5 mg tablet | Brand | $16.80 per tablet | $503.95 | no change |
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 linagliptin label say about other medicines?
The linagliptin label names 1 other medicine 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 |
|---|---|---|
| Rifampin | drug interactions | DRUG INTERACTIONS Strong P-glycoprotein/CYP3A4 inducer: The efficacy of TRADJENTA may be reduced when administered in combination (e.g., with rifampin). |
Source: FDA drug label (Tradjenta), Boehringer Ingelheim Pharmaceuticals, Inc., effective March 21, 2025 (SPL set c797ea5c-cab7-494b-9044-27eba0cfe40f), via openFDA; the full label on DailyMed
What do FAERS reports show for linagliptin?
The FDA Adverse Event Reporting System holds 18,132 reports that list linagliptin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,687 are coded as a death and 6,903 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 linagliptin?
30 other medicines are given the same way (oral) and in the same FDA class as 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 |
|---|---|---|---|---|
| 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 |
| Metformin and saxagliptin | Type 2 diabetes | 2 labelers | $9.65 per tablet 5-1,000 mg tablet | No current entry |
| Saxagliptin | Type 2 diabetes | 3 labelers | $1.04 per tablet 5 mg tablet | No current entry |
| Alogliptin and metformin | Type 2 diabetes | none listed | $2.46 per unit 12.5-1000 | No current entry |
| Ertugliflozin and sitagliptin | Type 2 diabetes | none listed | $17.59 per tablet 15-100 mg tablet | No current entry |
Every medicine labeled for the same conditions as linagliptin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does linagliptin compare with medicines for the same use?
2 side-by-side pages set linagliptin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to linagliptin
- 30 medicines for the same use
- Other DPP-4 inhibitors
- the pharmacologic class, with prices and generics
- Linagliptin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other