TheraRadar
Data updated: May 26, 2026

OSENI (alogliptin benzoate)

Metabolic Approved 2013-01-25
Jump to: Indications Approvals Trials Competitors Safety Patents
3
Indications
--
Phase 3 Trials
13
Years on Market

Details

Status
Discontinued
First Approved
2013-01-25
Patent Cliff
2029

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Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET

Companies

Takeda
Active Ingredient: ALOGLIPTIN BENZOATE , PIOGLITAZONE HYDROCHLORIDE

OSENI Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
66 FDA actions from 2013 to 2024 · 1 indication expansions
Jun 2024 SUPPL
Label · Labeling
FDA Letter Label
Mar 2022 SUPPL
Label · Labeling
FDA Letter Label
Jul 2019 SUPPL
Label · Labeling
FDA Letter Label

What OSENI Treats

3 FDA approvals

Originally approved for its first indication in 2013 . Covers 3 distinct patient populations.

  • Other (3)
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT02856113 results posted SYR-322_309 U1111-1174-1923, 2015-000208-25 Ph 3 completed Phase 3 Alogliptin Pediatric Study
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

OSENI FDA Label Details

View full patent landscape →
2 OB patents · 2 families · 148 international docs across 45 countries

OSENI Patents & Exclusivity

Latest Patent: Jun 2029

Patents (2 active)

US8637079 Expires Jun 4, 2029
US7807689 Expires Jun 27, 2028
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2029
  • • 72 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA022426 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.