Orange Book product · Brand (NDA)

XADAGO

SAFINAMIDE MESYLATE

Brand (NDA)NDA 207145TE ABRX MDD US

Mar 21, 2017

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 21, 2017
9 yr 5 mo ago
Today
Patent 8278485 expires
Listed drug substance patent expiration.
Jun 08, 2027
in 1 yr
Patent 8076515 expires
Listed drug substance patent expiration.
Dec 10, 2028
in 2 yr 6 mo
Patent 8283380 expires
Listed method-of-use patent (U-1993) expiration.
Mar 21, 2031
in 4 yr 10 mo

Active ingredient

SAFINAMIDE MESYLATE

Strength

EQ 50MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 207145

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
8278485	Jun 08, 2027	in 1 yr	SubstanceU-1993
8076515	Dec 10, 2028	in 2 yr 6 mo	SubstanceProductU-1993
8283380	Mar 21, 2031	in 4 yr 10 mo	U-1993