Orange Book product · Brand (NDA)

JANUMET XR

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Brand (NDA)NDA 202270TE ABRX MSD SUB MERCK

Feb 02, 2012

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 02, 2012
14 yr 7 mo ago
Today
Patent 7326708 expires
Listed drug substance patent expiration.
Nov 24, 2026
in 5 mo
Patent 7326708*PED expires
Listed listed patent expiration.
May 24, 2027
in 11 mo

Active ingredient

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Strength

1GM;EQ 50MG BASE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Application

NDA 202270

Product number

002

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7326708	Nov 24, 2026	in 5 mo	SubstanceProductU-1227
7326708*PED	May 24, 2027	in 11 mo