Orange Book product · Brand (NDA)

SEGLUROMET

ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE

Brand (NDA)NDA 209806RX 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 9308204 expires
Listed drug product patent expiration.
Oct 21, 2030
in 4 yr 5 mo
Patent 9439902 expires
Listed method-of-use patent (U-2214) expiration.
Oct 21, 2030
in 4 yr 5 mo
Patent 8080580 expires
Listed drug substance patent expiration.
Dec 19, 2031
in 5 yr 7 mo

Active ingredient

ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE

Strength

2.5MG;1GM

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 209806

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
9308204	Oct 21, 2030	in 4 yr 5 mo	Product
9439902	Oct 21, 2030	in 4 yr 5 mo	U-2214
8080580	Dec 19, 2031	in 5 yr 7 mo	SubstanceProductU-2214