Orange Book product · Brand (NDA)

STEGLATRO

ERTUGLIFLOZIN

Brand (NDA)NDA 209803RX MSD SUB MERCK

Dec 19, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 19, 2017
8 yr 7 mo ago
Today
Patent 8080580 expires
Listed drug substance patent expiration.
Dec 19, 2031
in 5 yr 7 mo

Active ingredient

ERTUGLIFLOZIN

Strength

5MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 209803

Product number

001

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
8080580	Dec 19, 2031	in 5 yr 7 mo	SubstanceProductU-2214