Viewing data from:

ZITUVIMET

NDA

METFORMIN HYDROCHLORIDE; SITAGLIPTIN | N216743 | ZYDUS LIFESCIENCES GLOBAL FZE

2 strengths0 unique patents0 unique exclusivities

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

6 trials from ClinicalTrials.gov, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Concomitant Administration of Sitagliptin and Metformin as Individual Tablets (0431A-048)NCT00961857	Phase 1	Completed	Merck Sharp & Dohme LLC	48	2005-12-01 → 2006-01-01
MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)NCT00482729	Phase 3	Completed	Merck Sharp & Dohme LLC	1,246	2007-06-19 → 2009-04-27
MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)NCT00532935	Phase 3	Completed	Merck Sharp & Dohme LLC	517	2008-01-26 → 2009-10-23
A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes (0431-068)(COMPLETED)NCT00541450	Phase 3	Completed	Merck Sharp & Dohme LLC	492	2008-01-15 → 2010-01-16
Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)NCT00929201	Phase 1	Completed	Merck Sharp & Dohme LLC	61	2008-01 → 2008-05
A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Co-administration of Sitagliptin and Metformin as Individual Tablets (0431A-095)NCT00961480	Phase 1	Completed	Merck Sharp & Dohme LLC	24	2007-10 → 2007-11

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$5.07

per ea

Lowest NADAC/Unit

$5.03

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
70710178606ZITUVIMET 50-500 MG TABLET	$5.07	EA	Brand	—	2026-06-17
70710178706ZITUVIMET 50-1,000 MG TABLET	$5.03	EA	Brand	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (4 FSS)

Lowest Price

$103.10

Highest Price

$233.37

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
70710-1786-06ZITUVIMET 50/500MG TAB	$233.37	FSS	Zydus Pharmaceuticals (USA) Inc.	08/14/2026
70710-1787-06ZITUVIMET 50/1000MG TAB	$232.61	FSS	Zydus Pharmaceuticals (USA) Inc.	08/14/2026
70710-1986-06METFORMIN HCL 500MG/SITAGLIPTIN PHOSPHATE 50	$103.10	FSS	Zydus Pharmaceuticals (USA) Inc.	08/14/2026
70710-1987-06METFORMIN HCL 1000MG/SITAGLIPTIN PHOSPHATE 50	$106.67	FSS	Zydus Pharmaceuticals (USA) Inc.	08/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 28, 2026	SUPPL -5	View Letter (PDF)
Nov 6, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG;50MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 3, 2023

No patent or exclusivity listings for this strength.

#002 — 1GM;50MG

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 3, 2023