Orange Book product · Brand (NDA)

BRISDELLE

PAROXETINE MESYLATE

Brand (NDA)NDA 204516TE ABRX LEGACY PHARMA

Jun 28, 2013

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 28, 2013
13 yr 2 mo ago
Today
Patent 8946251 expires
Listed drug substance patent expiration.
Aug 04, 2026
in 2 mo
Patent 9393237 expires
Listed method-of-use patent (U-904) expiration.
Aug 04, 2026
in 2 mo
Patent 8658663 expires
Listed drug substance patent expiration.
Apr 06, 2029
in 2 yr 10 mo

Active ingredient

PAROXETINE MESYLATE

Strength

EQ 7.5MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Application

NDA 204516

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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
8946251	Aug 04, 2026	in 2 mo	SubstanceProductU-904
9393237	Aug 04, 2026	in 2 mo	U-904
8658663	Apr 06, 2029	in 2 yr 10 mo	SubstanceProductU-904