Orange Book product · Brand (NDA)

ESOMEPRAZOLE MAGNESIUM

Brand (NDA)NDA 214278DISCN DEXCEL

Oct 20, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 20, 2020
5 yr 9 mo ago
Today
Patent 10076494 expires
Listed drug product patent expiration.
Dec 08, 2036
in 10 yr 8 mo
Patent 10835488 expires
Listed drug product patent expiration.
Dec 08, 2036
in 10 yr 8 mo

Active ingredient

ESOMEPRAZOLE MAGNESIUM

Strength

EQ 20MG BASE

Dosage form

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 214278

Product number

001

Marketing status

DISCN

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
10076494	Dec 08, 2036	in 10 yr 8 mo	Product
10835488	Dec 08, 2036	in 10 yr 8 mo	Product