Viewing data from:

SITAGLIPTIN PHOSPHATE

ANDA

SITAGLIPTIN PHOSPHATE | A202327 | WATSON LABORATORIES INC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: JANUVIA(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 7 NDCs

Highest NADAC/Unit

$3.77

per ea

Lowest NADAC/Unit

$3.47

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00480260956SITAGLIPTIN PHOSPHATE 100 MG TABLET	$3.77	EA	Generic	—	2026-08-05
00480260910SITAGLIPTIN PHOSPHATE 100 MG TABLET	$3.77	EA	Generic	—	2026-08-05
00480260998SITAGLIPTIN PHOSPHATE 100 MG TABLET	$3.77	EA	Generic	—	2026-08-05
00480260898SITAGLIPTIN PHOSPHATE 50 MG TABLET	$3.68	EA	Generic	—	2026-08-05
00480260856SITAGLIPTIN PHOSPHATE 50 MG TABLET	$3.68	EA	Generic	—	2026-08-05
00480260756SITAGLIPTIN PHOSPHATE 25 MG TABLET	$3.47	EA	Generic	—	2026-08-05
00480260798SITAGLIPTIN PHOSPHATE 25 MG TABLET	$3.47	EA	Generic	—	2026-08-05

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain68 active DMFs5 inactive

47 active API suppliers hold Drug Master Files for this ingredient.

MSN PHARMACHEM PRIVATE LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE USP (ROUTE CODE SG)

DMF 238642010

MATRIX PHARMACORP PRIVATE LTDSITAGLIPTIN PHOSPHATE USP

DMF 240672010

TAPI NL BVSITAGLIPTIN PHOSPHATE

DMF 241482010

SUN PHARMACEUTICAL INDUSTRIES LTDSITAGLIPTIN PHOSPHATE USP

DMF 241992010

APOTEX INCSITAGLIPTIN PHOSPHATE MONOHYDRATE USP

DMF 242662010

ALIVUS LIFE SCIENCES LTDSITAGLIPTIN PHOSPHATE

DMF 257732012

TAPI NL BVSITAGLIPTIN PHOSPHATE

DMF 258672012

ALIVUS LIFE SCIENCES LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE

DMF 267832013

ALIVUS LIFE SCIENCES LTDSITAGLIPTIN PHOSPHATE ANHYDROUS

DMF 268852013

MSN PHARMACHEM PRIVATE LTDSITAGLIPTIN PHOSPHATE ANHYDROUS USP [ROUTE CODE - SA]

DMF 269742013

WOCKHARDT BIO AGSITAGLIPTIN PHOSPHATE

DMF 270842013

BEIJING HUIKANG BOYUAN CHEMICAL TECH CO LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE

DMF 283252014

ZHEJIANG CHANGMING PHARMACEUTICAL CO LTDSITAGLIPTIN PHOSPHATE (NON-STERILE)

DMF 283442015

ZYDUS LIFESCIENCES LTDSITAGLIPTIN PHOSPHATE ANHYDROUS

DMF 286542014

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDSITAGLIPTIN PHOSPHATE ANHYDROUS

DMF 295082015

JUBILANT BIOSYS LTDSITAGLIPTIN PHOSPHATE USP

DMF 300822015

RUYUAN HEC PHARM CO LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE NON-STERILE BULK DRUG SUBSTANCE

DMF 301702016

MACLEODS PHARMACEUTICALS LTDSITAGLIPTIN PHOSPHATE (MONOHYDRATE)

DMF 307572016

HONOUR LAB LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE

DMF 308572016

HARMAN FINOCHEM LTDSITAGLIPTIN PHOSPHATE USP

DMF 309742016

HIKAL LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE (PROCESS-B)

DMF 315792017

SIGNA SA DE CVSITAGLIPTIN PHOSPHATE MONOHYDRATE USP

DMF 322982018

TORRENT PHARMACEUTICALS LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE USP

DMF 323332018

LUPIN MANUFACTURING SOLUTIONS LTDSITAGLIPTIN PHOSPHATE ANHYDROUS USP

DMF 326242018

APITORIA PHARMA PRIVATE LTDSITAGLIPTIN PHOSPHATE

DMF 329402018

HONOUR LAB LTDSITAGLIPTIN PHOSPHATE ANHYDROUS

DMF 329682018

FUXIN LONG RUI PHARMACEUTICAL CO LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE

DMF 330992018

BIOCON LTDSITAGLIPTIN PHOSPHATE

DMF 331432018

MOEHS IBERICA SLSITAGLIPTIN PHOSPHATE MONOHYDRATE

DMF 332062018

TAPI NL BVSITAGLIPTIN PHOSPHATE ENZYMATIC

DMF 334282019

MOREPEN LABORATORIES LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE

DMF 335172019

DR REDDYS LABORATORIES LTDSITAGLIPTIN PHOSPHATE USP (ANHYDROUS)

DMF 335512019

FUXIN LONG RUI PHARMACEUTICAL CO LTDSITAGLIPTIN PHOSPHATE

DMF 337912019

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDSITAGLIPTIN PHOSPHATE

DMF 341762019

MSN LIFE SCIENCES PRIVATE LTDSITAGLIPTIN PHOSPHATE ANHYDROUS

DMF 343782019

MSN LIFE SCIENCES PRIVATE LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE USP

DMF 347022020

HIKAL LTDSITAGLIPTIN PHOSPHATE ANHYDRATE

DMF 347342020

BIOCON LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE

DMF 349872020

LEE PHARMA LTDSITAGLIPTIN PHOSPHATE USP

DMF 351982020

MOREPEN LABORATORIES LTDSITAGLIPTIN PHOSPHATE ANYDROUS

DMF 355242020

DR REDDYS LABORATORIES LTDSITAGLIPTIN PHOSPHATE USP (MONOHYDRATE)

DMF 355802021

LAURUS LABS LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE USP

DMF 355842021

MANKIND PHARMA LTDSITAGLIPTIN PHOSPHATE

DMF 357022021

OPTIMUS DRUGS PRIVATE LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE

DMF 361392021

ZHEJIANG YONGTAI PHARMACEUTICAL CO LTDSITAGLIPTIN PHOSPHATE USP

DMF 361532021

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDSITAGLIPTIN PHOSPHATE USP

DMF 362072021

SHANDONG NEW TIME PHARMACEUTICAL CO LTDSITAGLIPTIN PHOSPHATE USP

DMF 364702022

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)SITAGLIPTIN PHOSPHATE MONOHYDRATE USP

DMF 369302022

ALMELO PRIVATE LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE USP

DMF 370202022

AMI LIFESCIENCES PRIVATE LTDSITAGLIPTIN PHOSPHATE USP

DMF 370302022

LEE PHARMA LTDSITAGLIPTIN PHOSPHATE USP (ROUTE-1)

DMF 372992022

UNION QUIMICO FARMACEUTICA SASITAGLIPTIN PHOSPHATE

DMF 374482023

CHROMO LABORATORIES INDIA PRIVATE LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE USP

DMF 385822024

CHEMO SMS ENTERPRISE SLSITAGLIPTIN PHOSPHATE USP

DMF 386142024

BIOCON LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE USP

DMF 387232023

IOL CHEMICALS AND PHARMACEUTICALS LTDSITAGLIPTIN PHOSPHATE USP

DMF 389312024

AMI LIFESCIENCES PRIVATE LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE

DMF 393542024

WAVELENGTH ENTERPRISES LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE

DMF 393772024

MSN LIFE SCIENCES PRIVATE LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE USP

DMF 394972024

ZHEJIANG JINGSHENG PHARMACEUTICAL CO LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE

DMF 399572024

RUYUAN HEC PHARM CO LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE NON-STERILE BULK DRUG SUBSTANCE (ENZYMATIC METHOD)

DMF 403082024

DR REDDYS LABORATORIES LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE (PRODUCT CODE: SPT-4)

DMF 405242024

APITORIA PHARMA PRIVATE LTDSITAGLIPTIN PHOSPHATE ANHYDROUS USP (PROCESS-II)

DMF 410702025

ZHEJIANG YONGTAI CHIRAL MEDICINE TECHNOLOGY CO LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE

DMF 414422025

CHIERON ACTIVE INGREDIENTS PRIVATE LTDSITAGLIPTIN PHOSPHATE MONOHYDRATE USP

DMF 420722025

AARTI PHARMALABS LTDSITAGLIPTIN PHOSPHATE ANHYDROUS

DMF 420812025

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)SITAGLIPTIN PHOSPHATE MONOHYDRATE USP PROCESS-II

DMF 425682025

SUN PHARMACEUTICAL INDUSTRIES LTDSITAGLIPTIN PHOSPHATE USP (PROCESS II)

DMF 431852025

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDInactiveSITAGLIPTIN PHOSPHATE ANHYDROUS

DMF 264252012

SICHUAN XIELI PHARMACEUTICAL CO LTDInactiveSITAGLIPTIN PHOSPHATE

DMF 264952012

SINTENOVO SA DE CVInactiveSITAGLIPTIN PHOSPHATE MONOHYDRATE

DMF 289082015

VIWIT PHARMACEUTICAL CO LTDInactiveSITAGLIPTIN PHOSPHATE MONOHYDRATE

DMF 292262015

VIWIT PHARMACEUTICAL CO LTDInactiveSITAGLIPTIN PHOSPHATE

DMF 301812015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 13, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 25MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 30, 2025

No patent or exclusivity listings for this strength.

#002 — EQ 50MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 30, 2025

#003 — EQ 100MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 30, 2025