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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

SITAGLIPTIN

ANDA

Tentative Approval

SITAGLIPTIN | A218441 | BIOCON PHARMA LTD

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Merck Sharp & Dohme LLC v. Biocon Pharma Ltd. et al 1:2023cv00683 1 patentANDA 218441sitagliptin phosphate	D. Del.	2023-06-23	Terminated 2023-08-14	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain7 active DMFs

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

ZYDUS LIFESCIENCES LTDSITAGLIPTIN FREE BASE

DMF 329652018

SYNAPTICS LABS PRIVATE LTDSITAGLIPTIN TRIAZOLE HYDROCHLORIDE [INTERMEDIATE OF SITAGLIPTIN; CAS NO. 762240-92-6]

DMF 385942023

MOEHS IBERICA SLSITAGLIPTIN BASE

DMF 389212023

SAI SREYAS PHARMACEUTICAL PRIVATE LIMITEDSITAGLIPTIN INTERMEDIATE [(3-(TRIFLUOROMETHYL)-5H,6H,7H,8H [1,2,4] TRIAZOLO[4,3-A] PYRAZINE HYDROCHLORIDE)]

DMF 390222023

JIANGSU BAJU PHARMACEUTICAL CO LTDSITAGLIPTIN BASE

DMF 395802024

ZHEJIANG YONGTAI CHIRAL MEDICINE TECHNOLOGY CO LTDSITAGLIPTIN BASE

DMF 412842025

ZHEJIANG YONGTAI CHIRAL MEDICINE TECHNOLOGY CO LTDSITAGLIPTIN BASE (PROCESS B-1)

DMF 428392025

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

Products (2)

Sort:

#002 — 50MG

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TABLET | TA Date: 2026-05-01 00:00:00

No patent or exclusivity listings for this strength.

#003 — 100MG

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TABLET | TA Date: 2026-05-01 00:00:00