Saxagliptin Hydrochloride

Sold as Onglyza. Every FDA application for this active ingredient: 1 branded and 5 generic.

As of Nov 15, 2026, FDA lists 6 applications for Saxagliptin Hydrochloride (sold as Onglyza), first approved Jul 31, 2009, with 7 new uses approved and 0 published complete response letters.

First approved: Jul 31, 2009
Applications: 6
New uses approved: 7
Complete response letters: 0
Medicare spending, 2025: $12.5M
First approved in the EU: Sep 30, 2009
First approved in Japan: Mar 25, 2013

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Saxagliptin HCl	Part D	$12.3M	-15%	15,287
Onglyza	Part D	$138K	-96%	149

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

SAXAGLIPTIN HCL 2.5 MG TABLET: $1.18 per unitGeneric · -59% in a year
SAXAGLIPTIN HCL 5 MG TABLET: $1.07 per unitGeneric · -68% in a year

Approvals in the EU (EMA)

First approved in the EU 2 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Onglyza, new substanceAstraZeneca AB · Sep 30, 2009

Approvals in Japan (PMDA)

First approved in Japan 44 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Onglyza, new ingredientDrugs with a new active ingredient indicated for the treatment of type 2 diabetes mellitus. · Otsuka Pharmaceutical Co., Ltd. · Mar 25, 2013

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes StudyCardiovascular Events, Type2 Diabetes · Brigham and Women's Hospital	—	Active, not recruiting	Feb 2, 2022

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jul 31, 2009	OnglyzaNDA 22350 · New molecular entity	Astrazeneca AB	14	Discontinued
Jul 31, 2023	SaxagliptinANDA 205941	Amneal	0	Discontinued
Jul 31, 2023	SaxagliptinANDA 205972	Aurobindo Pharma	0	Marketed
Jul 31, 2023	SaxagliptinANDA 205980	Mylan	0	Marketed
Jul 31, 2023	SaxagliptinANDA 205994	Glenmark Pharms Ltd	0	Marketed
Jul 31, 2023	SaxagliptinANDA 206078	Sun Pharm	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA