TheraRadar
Data updated: May 26, 2026

ONGLYZA (saxagliptin hydrochloride)

Metabolic Approved 2009-07-31
Jump to: Indications Approvals Trials Competitors Safety Patents
7
Indications
--
Phase 3 Trials
16
Years on Market

Details

Status
Discontinued
First Approved
2009-07-31
Patent Cliff
2028

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Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET

Companies

AstraZeneca
Active Ingredient: SAXAGLIPTIN HYDROCHLORIDE

ONGLYZA Approval History

2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
30 FDA actions from 2009 to 2024 · 6 indication expansions
Oct 2024 SUPPL
Efficacy
FDA Letter Label
Jul 2019 SUPPL
Label · Labeling
FDA Letter Label
Feb 2017 SUPPL
Efficacy
FDA Letter Label

What ONGLYZA Treats

7 FDA approvals

Originally approved for its first indication in 2009 . Covers 7 distinct patient populations.

  • Other (7)
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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.

ONGLYZA FDA Label Details

View full patent landscape →
1 OB patents · 1 families · 89 international docs across 34 countries

ONGLYZA Patents & Exclusivity

Latest Patent: Nov 2028

Patents (1 active)

US7951400 Expires Nov 30, 2028
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2028
  • • 4 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: NDA022350 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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