Data updated: Jun 28, 2026
ONGLYZA (saxagliptin hydrochloride) · AstraZeneca
Metabolic
Approved 2009-07-31
7
Indications
--
Phase 3 Trials
16
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2009-07-31
- Patent Cliff
- 2028
- Routes
- ORAL
- Dosage Forms
- TABLET
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
Nov 2015 SUPPL
Mfg
Jan 2014 SUPPL
Mfg
What ONGLYZA Treats
7 FDA approvalsOriginally approved for its first indication in 2009 . Covers 7 distinct patient populations.
- Other (7)
Other
(7 approvals)- • Approved indication (Jul 2009)Label Letter
- • Approved indication (Feb 2011)Label Letter
- • Approved indication (Dec 2011)Label Letter
- • Approved indication (May 2013)Label Letter
- • Approved indication (Apr 2016)Label Letter
- • Approved indication (Feb 2017)Label Letter
- • Approved indication (Oct 2024)Label Letter
AstraZeneca's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
BEYFORTUS
2023 NIRSEVIMAB-ALIP
1 designation
TRUQAP
2023 CAPIVASERTIB
3 designations
WAINUA (AUTOINJECTOR)
2023 EPLONTERSEN SODIUM
1 designation
IMJUDO
2022 TREMELIMUMAB-ACTL
1 designation
SAPHNELO
2021 ANIFROLUMAB-FNIA
2 designations
TEZSPIRE
2021 TEZEPELUMAB-EKKO
2 designations
KOSELUGO
2020 SELUMETINIB
4 designations
LOKELMA
2018 SODIUM ZIRCONIUM CYCLOSILICATE
CALQUENCE
2017 ACALABRUTINIB
4 designations
IMFINZI
2017 DURVALUMAB
3 designations
FASENRA
2017 BENRALIZUMAB
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Pro Active Pipeline
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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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- • 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
Data sourced from official FDA and NIH databases. Click links to verify on original sources.