Sitagliptin Phosphate

For type 2 diabetes mellitus. Sold as Januvia. Every FDA application for this active ingredient: 1 branded and 15 generic.

As of Nov 15, 2026, FDA lists 16 applications for Sitagliptin Phosphate (sold as Januvia), first approved Oct 16, 2006, with 8 new uses approved and 0 published complete response letters.

First approved: Oct 16, 2006
Applications: 16
New uses approved: 8
Complete response letters: 0
Medicare spending, 2025: $2.15B
First approved in the EU: Mar 20, 2007
First approved in Japan: Oct 16, 2009

Medicare Spending

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

Product	Part	Spending, 2025	Change	Beneficiaries
Januvia	Part D	$2.15B	-44%	787,305

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

SITAGLIPTIN PHOSPHATE 100 MG TABLET: $3.85 per unitGeneric · new this year
SITAGLIPTIN PHOSPHATE 25 MG TABLET: $3.61 per unitGeneric · new this year
SITAGLIPTIN PHOSPHATE 50 MG TABLET: $3.72 per unitGeneric · new this year
JANUVIA 100 MG TABLET: $10.55 per unitBrand · 0% in a year
JANUVIA 25 MG TABLET: $10.54 per unitBrand · 0% in a year
JANUVIA 50 MG TABLET: $10.55 per unitBrand · 0% in a year

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

treatment of Duchenne muscular dystrophyRevio Therapeutics LLP · designated Jan 15, 2026

Approvals in the EU (EMA)

First approved in the EU 5 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Sitagliptin Accord, genericAccord Healthcare S.L.U. · Apr 25, 2022
Sitagliptin SUN, genericSun Pharmaceutical Industries Europe B.V. · Dec 9, 2021
RistabenMerck Sharp & Dohme B.V. · Mar 15, 2010
TesavelMerck Sharp & Dohme B.V. · Jan 10, 2008
XeleviaMerck Sharp & Dohme B.V. · Mar 21, 2007
Januvia, new substanceMerck Sharp and Dohme B.V · Mar 20, 2007

Approvals in Japan (PMDA)

First approved in Japan 36 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

JanuviaDrugs with a new indication for the treatment of type 2 diabetes mellitus. · Ono Pharmaceutical Co., Ltd. · May 23, 2014
GlactivDrugs with a new additional indication for the treatment of type 2 diabetes mellitus in patients who have not responded sufficiently to insulin along with… · MSD K.K. · Sep 16, 2011
JanuviaDrugs with a new additional indication for the treatment of type 2 diabetes mellitus in patients who have not responded sufficiently to alpha- glucosidase… · Ono Pharmaceutical Co., Ltd. · May 20, 2011
Januvia, new ingredientDrugs with a new active ingredient indicated for the treatment of type 2 diabetes mellitus (for use only in patients who do not sufficiently respond to any… · Ono Pharmaceutical Co., Ltd. · Oct 16, 2009 · Review report

Clinical Trials

28 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Effect of Proliverenol on Liver Fat and Insulin Resistance in Type 2 DiabetesDiabetes Mellitus, Type 2 · Universitas Sriwijaya	Phase 2	Recruiting	Nov 10, 2026
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney DiseaseDiabetic Kidney Disease (DKD), Type 2 Diabetes · Beijing University of Chinese Medicine	Phase 2	Active, not recruiting	Oct 30, 2026
Disease-modifying Efficacy of Sitagliptin Therapy in Early-stage Parkinson's DiseaseParkinson Disease · Yonsei University	Phase 2	Not yet recruiting	Sep 4, 2026
Sun Yat-Sen Treatment Strategy for Enhancing Response in Muscle-invasive Bladder CancerBladder Urothelial Carcinoma, Bladder Cancer · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Phase 2	Recruiting	Jul 21, 2026
Efficacy and Safety of Canagliflozin in the Treatment of Type 2 Diabetes With Mild Cognitive ImpairmentType 2 Diabetes Mellitus, Cognitive Impairment · Fudan University	Phase 4	Recruiting	Jul 17, 2026
PTCy, Bortezomib and Sitagliptin for Prevention of GvHD Following Allogeneic HSCTGVHD - Graft-Versus-Host Disease · Northwell Health	Phase 1 / Phase 2	Recruiting	Jun 30, 2026
Sitagliptin With Pembro in RCC and MelanomaAdvanced Renal Cell Carcinoma, Advanced Melanoma · Fernando Maciel Barbosa	Phase 1	Recruiting	Jun 8, 2026
Sitagliptin in Recurrent/Progressive Grade 4 GliomaGlioma, Glioblastoma · Kailin Yang, MD, PhD	Phase 1	Recruiting	Apr 21, 2026

Applications

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


Oct 16, 2006	JanuviaNDA 21995 · New molecular entity	Msd	35	Marketed
Dec 29, 2025	Sitagliptin PhosphateANDA 202327	Watson Labs Inc	0	Marketed
Jan 14, 2026	Sitagliptin PhosphateANDA 202387	Sandoz	0	Marketed
Jan 20, 2026	Sitagliptin PhosphateANDA 202425	Apotex	0	Marketed
—	Sitagliptin PhosphateANDA 202423	Sun Pharma Global	0	Discontinued
—	Sitagliptin PhosphateANDA 202473	Mylan Pharms Inc	0	Discontinued
—	Sitagliptin PhosphateANDA 202487	Teva Pharms USA	0	Discontinued
—	Sitagliptin PhosphateANDA 208186	Zydus Pharms USA Inc	0	Discontinued
—	Sitagliptin PhosphateANDA 211073	Macleods Pharms Ltd	0	Discontinued
—	Sitagliptin PhosphateANDA 214693	Unichem Labs Ltd	0	Discontinued
—	Sitagliptin PhosphateANDA 214700	Dr Reddys Labs Ltd	0	Discontinued
—	Sitagliptin PhosphateANDA 214784	Ajanta Pharma Ltd	0	Discontinued
—	Sitagliptin PhosphateANDA 215155	Alkem Labs Ltd	0	Discontinued
—	SitagliptinANDA 216086	Msn Laboratories Private Ltd	0	Discontinued
—	SitagliptinANDA 216919	Mankind Pharma Ltd	0	Discontinued
—	SitagliptinANDA 217041	Fosun Wanbang (Jiangsu) Pharmaceutical Group Co.,	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