Orange Book product · Brand (NDA)

ARYNTA

LISDEXAMFETAMINE DIMESYLATE

Brand (NDA)NDA 219847RX AZURITY

Jun 16, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 16, 2025
1 yr ago
Today
Patent 12433859 expires
Listed drug product patent expiration.
Apr 16, 2040
in 14 yr
Patent 12582620 expires
Listed drug product patent expiration.
Apr 16, 2040
in 14 yr
Patent 11576878 expires
Listed drug product patent expiration.
Aug 30, 2040
in 14 yr 5 mo

Active ingredient

LISDEXAMFETAMINE DIMESYLATE

Strength

10MG/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 219847

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
12433859	Apr 16, 2040	in 14 yr	ProductU-842
12582620	Apr 16, 2040	in 14 yr	Product
11576878	Aug 30, 2040	in 14 yr 5 mo	Product