Prescription medicine
Alogliptin and pioglitazone Brand names: Oseni
Alogliptin and pioglitazone (Oseni) is a prescription medicine with an FDA approval on record since 2013. No generic is listed; pharmacies paid $4.73 per alogliptin-pioglit 25-15 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the alogliptin and pioglitazone FDA label on DailyMed (effective February 28, 2025, Takeda Pharmaceuticals America, Inc.); the NDA 22426 record on Drugs@FDA; every alogliptin and pioglitazone label on DailyMed.
Highlights of the record
FDA label of February 28, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
CONGESTIVE HEART FAILURE.
Thiazolidinediones, including pioglitazone, which is a component of OSENI ® , cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1) ]. After initiation of OSENI and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea and/or edema). If congestive heart failure develops while taking OSENI, consider discontinuation of OSENI or dosage reduction of pioglitazone in OSENI [see Warnings and Precautions (5.1) ]. OSENI is not recommended in patients with symptomatic heart failure [see Warnings and Precautions (5.1) ]. Initiation of OSENI in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated [see Contraindications (4) and Warnings and Precautions (5.1) ]. WARNING: CONGESTIVE HEART FAILURE See full prescribing information for complete boxed warning Thiazolidinediones, including pioglitazone, which is a component of OSENI, cause or exacerbate congestive heart failure in some patients. ( 5.1 ) After initiation of OSENI and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea and/or edema). […]
Used for
From the label: indications and usageOSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Forms and strengths
- 12.5 mg / 30 mg
- 25 mg / 30 mg
- 25 mg / 45 mg
- 25 mg / 15 mg
Film-coated tablet.
On the market
- Earliest approval on file
- January 25, 2013 Oseni, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- June 4, 2029 Oseni tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $4.73 per tablet Alogliptin-pioglit 25-15 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 249 through July 30, 2026
What is alogliptin and pioglitazone used for?
From the label: indications and usageOSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. OSENI is a combination of alogliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone, a thiazolidinedione agonist of peroxisome proliferator receptor gamma, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: OSENI is not recommended for use in patients with type 1 diabetes mellitus. ( 1 ) Limitations of Use OSENI is not recommended for use in patients with type 1 diabetes mellitus.
Conditions named in the indications of alogliptin and pioglitazone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Dipeptidyl Peptidase 4 Inhibitor, Peroxisome Proliferator Receptor alpha Agonist, Peroxisome Proliferator Receptor gamma Agonist and Thiazolidinedione.
Source: FDA drug label (OSENI), Takeda Pharmaceuticals America, Inc., effective February 28, 2025 (SPL set 4c619ed9-fe3e-4158-9938-80c6c3493d55), via openFDA; the full label on DailyMed
What does the patient leaflet for alogliptin and pioglitazone 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 OSENI?OSENI can cause serious side effects, including: 1. Heart failure: OSENI can cause heart failure and cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. Heart failure means your heart does not pump blood well enough. Before you start taking OSENI: Tell your healthcare provider if you have ever had heart failure or have problems with your kidneys. Call 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. 2. Inflammation of the pancreas (pancreatitis): Alogliptin, one of the medicines in OSENI, may cause pancreatitis, which may be severe. Certain medical conditions make you more likely to get pancreatitis. Before you start taking OSENI: Tell your healthcare provider if you have ever had: pancreatitis high blood triglyceride levels kidney problems stones in your gallbladder (gall stones) liver problems a history of alcoholism Stop taking OSENI 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 through 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 OSENI?Store OSENI at room temperature between 68°F to 77°F (20°C to 25°C). Keep container tightly closed and protect from moisture and humidity. Keep OSENI and all medicines out of the reach of children.
Source: FDA drug label (OSENI), Takeda Pharmaceuticals America, Inc., effective February 28, 2025 (SPL set 4c619ed9-fe3e-4158-9938-80c6c3493d55), via openFDA; the full label on DailyMed
Is there a generic for alogliptin and pioglitazone (Oseni)?
No generic alogliptin and pioglitazone is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Oseni tablets: the compound patent runs to June 27, 2028, and the last listed entry to June 4, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2013 earliest approval on file
- 2029 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for alogliptin and pioglitazone (Oseni)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $4.73 per Alogliptin-pioglit 25-15 mg tablet, down 14% from $5.52 on October 8, 2025. 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.
- Alogliptin-pioglit 25-15 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Alogliptin-pioglit 25-15 mg tablet | Generic | $4.73 per tablet | $141.94 | -14% |
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 alogliptin and pioglitazone label say about other medicines?
The alogliptin and pioglitazone label names 3 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 |
|---|---|---|
| Gemfibrozil | drug interactions | DRUG INTERACTIONS Strong CYP2C8 inhibitors (e.g., gemfibrozil) increase pioglitazone concentrations. |
| Rifampin | drug interactions | Limit the pioglitazone dose to 15 mg daily. ( 7.2 ) CYP2C8 inducers (e.g., rifampin) may decrease pioglitazone concentrations. ( 7.3 ) Topiramate may decrease pioglitazone concentrations. |
| Topiramate | drug interactions | Limit the pioglitazone dose to 15 mg daily. ( 7.2 ) CYP2C8 inducers (e.g., rifampin) may decrease pioglitazone concentrations. ( 7.3 ) Topiramate may decrease pioglitazone concentrations. |
Source: FDA drug label (OSENI), Takeda Pharmaceuticals America, Inc., effective February 28, 2025 (SPL set 4c619ed9-fe3e-4158-9938-80c6c3493d55), via openFDA; the full label on DailyMed
What do FAERS reports show for alogliptin and pioglitazone?
The FDA Adverse Event Reporting System holds 249 reports that list alogliptin and pioglitazone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 36 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 alogliptin and pioglitazone?
28 other medicines are given the same way (oral) and in the same FDA class as alogliptin and pioglitazone 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 |
| Linagliptin and metformin | Type 2 diabetes | 1 labeler | $8.44 per tablet 2.5 mg-1,000 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 |
| 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 |
| 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 alogliptin and pioglitazone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to alogliptin and pioglitazone
- 28 medicines for the same use
- Other DPP-4 inhibitors
- the pharmacologic class, with prices and generics
- Alogliptin and pioglitazone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other