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NDA

SITAGLIPTIN | N211566 | ZYDUS LIFESCIENCES GLOBAL FZE

3 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

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2035

Today

10925871

Feb. 25, 2035

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Merck Sharp & Dohme LLC v. Zydus Worldwide DMCC et al 1:2021cv00315 1 patentsitagliptin phosphate	D. Del.	2021-03-01	Terminated 2022-12-09	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 19, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 25MG

RLD

1 patent0 exclusivities▴

TABLET;ORAL | Approved: Oct 18, 2023

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10925871	Feb 25, 2035	—	—	Yes	—	—

#002 — 50MG

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Oct 18, 2023

#003 — 100MG

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Oct 18, 2023